Blog Tag: FDA

FDA to Strengthen Cybersecurity Oversight

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the premarket review process for medical devices. In particular, the report suggests including cybersecurity documentation as a criterion in the FDA’s Refuse-To-Accept (RTA) checklist, using presubmission meetings to address cybersecurity questions, and including cybersecurity as an element of the FDA’s Smart template.

The FDA has been ramping up its cybersecurity review lately to deal with increased cybersecurity concerns. For example, a ransomware attack caused an Indiana hospital to shut down its system. Other cyberattacks may have gone undetected.

Currently, the FDA reviews documentation that manufacturers submit regarding cybersecurity as part of the premarket submissions. The FDA uses this information to consider known cybersecurity risks and threats when reviewing submissions that deal with networked medical devices. The FDA may request additional information from applicants when submissions require clarification or when cybersecurity documentation is lacking. In view of these requests, the FDA regularly approves manufacturers on cybersecurity issues when sufficient documentation is provided.

For example, in one review of a glucose monitoring system, an FDA reviewer did not find “any information on how the manufacturer included cybersecurity in the device’s design,” according to the report. “The FDA reviewer explained that the device relied heavily on users to protect against cybersecurity threats by using antivirus software and enabling firewalls. The FDA reviewer requested that the manufacturer update its hazard analysis to address the missing information. The manufacturer did so, and FDA found the update to be acceptable.”

Because of examples like this, the report suggests using cybersecurity documentation as an element in the FDA’s RTA checklist. The RTA checklist is a screen against incomplete applications. Were cybersecurity part of these checklists, failure by a manufacturer to provide adequate cybersecurity documentation could prevent the FDA to accept the submission for substantive review.

The report also suggests that the FDA use presubmission meetings to address cybersecurity-related questions. These meetings serve as a way for manufacturers to ask the FDA specific questions, such as whether the submission satisfies the FDA’s standards. During these meetings, the FDA can include cybersecurity as part of the discussion, which may reduce the amount of time for the FDA review.

Finally, the report recommended that cybersecurity be a stand-alone element in the FDA’s Smart template. A dedicated section on cybersecurity could allow FDA reviewers to explain the results of their review regarding cybersecurity in a standard format.

The FDA has agreed with these recommendations and has begun taking steps to implement them, such as by including cybersecurity in the Smart template. The FDA also said that it “intends to update the RTA checklist and the accompanying guidance to specifically identify cybersecurity as an item in the checklist during the next update of these items.” The FDA is also currently considering new rules that may require submission of software as part of a premarket submission.

FDA Grants Breakthrough Status to Dthera Sciences’ Alzheimer’s Therapeutic

FDA Grants Breakthrough Status to Dthera Sciences’ Alzheimer’s Therapeutic

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy designation is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments. A therapy that receives Breakthrough Therapy designation will be reviewed within 60 days of receipt.

Dthera Sciences chief executive officer Edward Cox stated:

We commend the FDA for recognizing this significant unmet medical need as well as the critical importance of providing innovative new treatments to patients with Alzheimer’s and their caregivers.

According to Dthera Sciences, the therapeutic device, termed DTHR-ALZ, is a prescription digital therapeutic for patients with Alzheimer’s disease. The device digitally delivers ReminX, a reminiscence therapy, to patients with Alzheimer’s disease and automatically optimizes the therapy using biofeedback. Reminiscence therapy is a behavioral intervention that involves introduction of familiar pictures, music, or other materials to help patients reminisce about past experiences.

According to the press release, Alzheimer’s disease is a neurodegenerative disease that is among the ten leading causes of death in the United States. In addition, it is one of the most financially costly diseases. According to Dthera Sciences, DTHR-ALZ mitigates the symptoms of agitation and depression associated with Alzheimer’s disease with minimal investment of time and resources.

FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse.  With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA intends to encourage development of medical devices that will help to combat the ongoing opioid crisis.

According to the announcement, diagnostic and therapeutic devices at any stage of development are eligible for submission to the Challenge.  The FDA also indicates that currently marketed devices may be submitted if developers are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain.  Non-limiting examples of suitable medical devices provided by the FDA include diagnostic devices that identify patients at increased risk for addiction, opioid-sparing or opioid-replacement therapies for acute or chronic pain, and devices that monitor the use and prevent diversion of prescription opioids.

According to the announcement, Challenge submissions should describe:

  • The novelty of the medical device/concept,
  • The development plan for the medical device,
  • The development team, and
  • The anticipated benefit of the device used by patients and the impact on public health as compared to other available alternatives.

The FDA has indicated that they will work directly with selected applicants during a collaboration phase to accelerate the development and review of new devices, similar to the process under the existing Breakthrough Devices Program.  The announcement also reports that selected devices will also be granted Breakthrough Device designation without requiring a separate application.  Challenge applications will be accepted through September 30, 2018.  The FDA will be hosting a webinar on July 25, 2018 to provide further information.

Medtronic Launches Deep Brain Stimulation Clinician Programmer for Use with Samsung Tablet

Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is presently being launched in Europe and is expected to be launched in the United States before the end of July 2018.

DBS therapy involves the delivery of electrical stimulation to specific areas of the brain using a surgically-implanted device. About 125,000 Medtronic Activa devices are implanted globally. Medtronic’s Activa DBS system is used as therapy for neurological diseases including Dystonia and Parkinson’s disease.

The Activa Programming Application is designed for use with the Samsung Galaxy Tab S2 tablet. According to Medtronic’s press release, the purpose of the application is to “enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients.” The programmer is expected to have an immediate impact on thousands of patients’ post-implant care.  For example, the programmer will allow the service life of certain Activa rechargeable implantable neurostimulators to be extended by 6 years, giving patients about 15 years between device replacement surgeries.

Dr. Mohammad Maarouf, associate professor, head of the Department of Stereotaxy and Functional Neurosurgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Germany stated that the programmer’s “intuitive, visual interface and task-based workflow makes daily use easier, saving [him] time to focus on what’s most important-[his] patients.”

According to Medtronic’s press release, Medtronic’s DBS Clinician Programmer is also approved for use with the Activa DBS systems for treating refractory epilepsy, which will be launched in the United States later this year.

The FDA’s Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

The FDA’s Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.”

FDA Commissioner Scott Gottlieb stated that “[m]edical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis.” Medical devices can be used to address opioid addiction by, for example, effectively addressing local pain syndromes in order to supplant the use of systemic opioids and reduce the use of opioids. “New digital technology products and diagnostic tests could help in the opioid addiction fight by detecting, treating, and preventing addiction; addressing diversion of the opioid supply chain to illicit use; and treating pain,” the FDA said.

According to Bloomberg, “accepted companies will get to work more closely with the FDA’s review offices than usual to help get their products approved. Products that qualify as breakthrough devices under food and drug law will receive that designation without the sponsor needing to submit an application, the agency said. A breakthrough device designation can reduce the time and cost to get a product to market that addresses life-threatening or irreversibly debilitating diseases.”

The innovation challenge is open to any product in any stage of development. The challenge also is open to developers of currently marketed devices who can show that their devices have an improved benefit-risk profile compared to opioid use in pain management. The FDA anticipates “that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application.”

This innovation challenge is part of the FDA’s plan to aid in the opioid crisis and supports several overarching goals of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis. On April 20, 2018, the agency also released the first of two new draft guidances intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence.

FDA Unveils Update to Software Precertification Program

The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA expects to roll out a finalized version of the program by December 2018 and to have a pilot test available in 2019.

With the precertification program, the FDA hopes to streamline the certification of “mobile apps” and other software that is used to “treat, diagnose, cure, mitigate, or prevent disease or other conditions,” or so-called software as a medical device (SaMD), according to the updated program description. While software in a medical device (SiMD) is not currently part of the program, the FDA hopes to include SiMD and software that is an accessory to hardware in the future. The program will allow certain organizations that can demonstrate a “culture of quality and organizational excellence” to streamline their oversight of SaMD.

The update clarifies that not all software is subject to regulatory review even if it has some connection to the medical industry. In particular, the update notes that non-device software is exempt, such as software that is intended for (1) for administrative support, (2) for maintaining or encouraging a healthy lifestyle, (3) to serve as electronic patient records, (4) for transferring, storing, converting formats, or for displaying data, or (5) to provide certain limited clinical decision support.

According to the update, organizations “of all sizes” can qualify. The FDA makes clear that startups and smaller companies can apply and receive precertification. Two levels of precertification exist. Level 1 precertification allows an organization to develop and market “lower risk” software without review while also streamlining review of higher risk software. This level would be awarded to an organization that demonstrates excellence in product development but may have a “limited track record” in “developing, delivering, and maintaining” products in the healthcare market. Level 2 precertification allows “lower and moderate risk” software to be developed and marketed without review and allowing streamlined review of other software. This level is awarded to those organizations with a track record in demonstrating high quality software products.

In determining what amount of review is required for “lower risk” and “moderate risk” SaMD, the FDA looks at (1) the risk category of the product, (2) the level of precertification of the organization, and (3) the extent of the changes the software relative to an existing device. Under either level of precertification, “minor changes” require no review by the FDA.

The FDA is looking to update additional aspects of the precertification program, including how it relates to substantially equivalent device review. The FDA is currently requesting comments on the program.

FDA grants De Novo Market Clearance of Artificial Intelligence Software

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the “first artificial intelligence triage software” and its approval begins “a new era of intelligent stroke care begins as regulatory approval.” The Viz.AI LVO Stroke Platform, according to the U.S. Food and Drug Administration press release, is a clinical support software designed to analyze Computerized Tomography (CT) scans, identify suspected large vessel blockage, and send a notification to specialist of a potential stroke in patients sooner.

According to the Centers for Disease Control and Prevention, strokes are the fifth leading cause of death in America. A stroke occurs when the blood vessels in the brain are damaged, compromising the necessary blood flow to the brain. There are many types of strokes and can often lead to brain damage, long term disability, and death. A CT scan can show the location and extent of the damage to the brain to diagnose the stroke as well as the type of stroke that has occurred.

Viz.AI is a healthcare company based in San Francisco and Tel Aviv, dedicated to “expand Direct-to Intervention care” which “advances information about treatable patients straight to the interventionalist.” Neurosurgeon and CEO of Viz.Al, Dr. Chris Mansi stated in a press release:

“The Viz.ai LVO Stroke Platform is the first example of applied artificial intelligence software that seeks to augment the diagnostic and treatment pathway of critically unwell stroke patients.”

According to the FDA press release, Viz. AI Contact application was granted De Novo premarket review, which is a “regulatory pathway for new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence.” This is a new regulatory classification, “which means that subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Viz.AI Contact application is one example of what the FDA calls “clinical decision support software (CDS). CDS includes technology that aids in diagnosing and identifying treatment plans. CDS includes “technology has the potential to enable providers and patients to fully leverage digital tools to improve decision making.” The FDA is currently creating a regulatory framework for CDS to provide guidance and encourage developers in this field.

According to Robert Ochs, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, “(This) software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke.”

23andMe Wins FDA Approval for Test to Detect BRCA Mutations

The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants).  According to an FDA news release, the approved test is the first direct-to-consumer test to report on three specific BRCA1 and BRCA2 breast cancer gene mutations. 

According to the news release, BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins.  Mutations of these genes may interfere with the production or functioning of the proteins and are linked to an increased risk of female breast and ovarian cancers.  About 12% of women in the U.S. population will develop breast cancer sometime during their lives.  However, according to the National Cancer Institute, a recent large study estimated that about 72% of women who inherit a harmful BRCA1 mutation will develop breast cancer by the age of 80.  Similarly, about 69% of women who inherit a harmful BRCA2 mutation will develop breast cancer by age 80.  Because mutations of the BRCA1 and BRCA2 genes may be passed down to future generations, genetic testing for breast cancer risk has become more common.

23andMe offers genetic testing directly to consumers.  Traditionally, genetic testing was only available through healthcare providers: an individual would request tests from a healthcare provider, the healthcare provider would order tests from a laboratory, collect and send the samples, and interpret the test results before passing them onto the individual.  In contrast, direct-to-consumer genetic testing allows consumers to order and perform genetic tests without needing to interact with a healthcare professional.  23andMe has previously offered direct-to-consumer tests for the purposes of discovering an individual’s ancestry.  However, this new FDA approval indicates expansion of genetic testing services to other applications.

Although the FDA approval of 23andMe’s test is positive, the FDA expressly noted certain caveats regarding the test.  Specifically, the FDA clarified that the test only detects three out of more than 1,000 known BRCA mutations and that only a small percentage of Americans carry one of the three mutations.  A negative result therefore does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.  Additionally, the FDA is establishing criteria, called special controls, which set forth the agency’s expectations in assuring the test’s accuracy and performance.  Though this test may be a precursor for exciting possibilities on the horizon, the FDA warned that this limited test should not completely replace consultations with a health care professional.   

 

 

 

 

FDA Approves Blood Test for Concussion

FDA Approves Blood Test for Concussion

The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway.   According to the press release, Banyan BTI is the first in vitro diagnostic blood test for the evaluation of mild traumatic brain injuries (mTBI), commonly referred to as concussions, authorized for marketing by the FDA.   

According to Banyan Biomarkers, more than 90 percent of patients presenting to the emergency department with mTBI receive a negative CT scan.  Banyan BTI purports to identify two brain-specific protein biomarkers that rapidly appear in the blood after a brain injury, providing information to assess patients with suspected mTBI.  According to the FDA, availability of a blood test for concussions will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

With respect to approval of Banyan BTI, FDA Commissioner Scott Gottlieb, M.D. stated:

“A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”

 

FDA Clears New Surgery Infection Control System

FDA Clears New Surgery Infection Control System

The FDA recently cleared Prescient Surgical’s CleanCisionTM  Wound Retraction and Protection System (CleanCisionTM), a retractable device designed to prevent surgical site infection. According to Prescient Surgical, CleanCisionTM is “a novel, first-in-class, advanced intraoperative infection control system” that utilizes an active cleansing technology.

Traditionally, practices for preventing surgical site infections (SSIs) involve administering drugs, controlling patient’s blood glucose level, maintaining optimal temperature and tissue oxygenation, using skin prep agents, and using plastic wound protectors.

The press release states that unlike traditional methods, ClearCision combines wound protection and wound cleansing. Retractable plastic sleeves protect the wound while providing direct access to the surgical site. Irrigation system continuously cleans the wound edge using sterile irrigant solution and removes contaminant using suction. Insoo Suh, cofounder of Prescient Surgical, noted that ClearCision is “a proactive approach to clearing contamination during surgery.”

The press release also notes that SSIs can be caused by bacteria entering the surgical incision site, and lead to significant financial burdens on teh healthcare system.

Jonathan Coe, cofounder, president, and CEO of Prescient Surgical, said in the press release that the company is “initially focusing on abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of [SSI] is high and the need is acute.”

Seizure-Detecting Smart Watch Given FDA Approval

The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for dangerous seizures, including grand mal or generalized tonic-clonic seizures. These seizures cause loss of consciousness and can cause a state of confusion in patients for periods of time after they finish. Embrace is said to allow medical professionals to gain information about when seizures happen with higher accuracy than was previously available and can also alert caregivers when patients are having seizures. During a seizure, the watch vibrates, LEDs light up, and an alert is sent via Bluetooth to the patient’s smartphone. An app on the phone can then send a distress signal via text or phone call to one or more caregivers.

The device was previously approved by the European Medical Agency in April 2017. According to articles, the technology was originally developed at MIT in 2007 and was funded by a successful crowdfunding campaign in 2014, which netted the maker, Empatica, more than $800,000. Embrace went on sale shortly after that campaign and has been available commercially but was not previously available as a medical device in the U.S.

The FDA’s approval was reportedly based on a clinical trial of 135 patients over 272 days. Each of the patients had epilepsy and were simultaneously monitored by EEG and using Embrace. The trial recorded over 6500 hours of data, including 40 seizures, which Embrace detected with 100% accuracy.

Matteo Lai, Co-Founder and CEO of Empatica, touted Embrace’s design and functionality, saying “We wanted to design the world’s first medical device that could win a design award, while being used as a lifesaving product.” Embrace is said to be the first smart watch to be approved by the FDA for neurological monitoring.

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device.

According to Gene Saragnese, Chairman & CEO of MedyMatch, the platform is a “first-in-class hemorrhage detection tool.”  The MedyMatch device utilizes artificial intelligence and deep learning technologies to analyze non-contrast head CT images for signs of ICH.  Further implementations of the MedyMatch deep vision platform include diagnosis and monitoring of acute and chronic diseases based on concurrent analysis of imaging data and other patient data.  Vice President of Clinical, Regulatory, and Quality Affairs, Dr. Joshua Schulman, said:

This designation is a recognition of both the need for new assessment tools for intracranial hemorrhage and an affirmation of MedyMatch’s technical approach to assisting clinicians to need to make time-sensitive yet accurate decisions in emergency settings.

The EAP Program, intended to speed approval of certain medical devices, generally includes priority review, more interactive review, and senior management involvement.  EAP designation can be awarded for devices that address unmet needs for treatment or diagnosis of life-threatening or irreversibly debilitating conditions.    It is said to be expected that EAP designated devices will be transitioned to the new Breakthrough Devices program established under the 21st Century Cures Act of 2016.

FDA Issues Draft Guidance for “Least Burdensome” Approach to Device Regulation

The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.”  The FDA provides this draft guidance following a December 2017 Government Accountability Office (GAO) report assessing the FDA’s application of the “least burdensome” approach to regulation.

The least burdensome mandate for medical devices has been a part of the FDA’s governing law since Congress’ passage of the FDA Modernization Act of 1997.  Its intent is to eliminate unnecessary delays for approving new devices, while still maintaining the statutory requirements for approval.   The GAO report found that, between 2013 and 2016, device sponsors had appealed FDA staff decisions to agency management a total of 63 times.  Of these 63 appeals, 33 raised issues related to the FDA’s application of the least burdensome approach, and the FDA at least partially agreed in 11 of these cases.  The GAO report further notes that the FDA has not evaluated its compliance with the least burdensome mandate and suggests the development of performance metrics to meet this end.

FDA Commissioner Scott Gottlieb states that he is “fully committed” to implementing the least burdensome mandate.  The draft guidance defines least burdensome to be the “minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.”  The guiding principles espoused in the draft guidance include the FDA’s intent to require the “minimum information necessary to adequately address the regulatory question or issue at hand,” a call for industry sponsors to submit “well-organized, clear, and concise information” for the FDA to review, and the FDA’s commitment to apply regulatory approaches that “fit the technology, taking into account its unique innovation cycles, evidence generation needs, and timely patient access.”

The draft guidance also provides examples of how the least burdensome approach can be applied.  For example, it suggests that:

  • Computer modeling and simulations “should be used to support medical device safety and effectiveness as alternatives to traditional benchtop or animal performance testing in appropriate circumstances.”
  • “Alternative approaches should be considered, when appropriate, to optimize the time and resources of FDA and industry. Both FDA and industry should understand that there are often
    multiple ways to satisfactorily address a particular regulatory issue. The resolution of the regulatory issue should be based on a discussion about which method is least burdensome, while still satisfactorily addressing the regulatory issue.”
  • “Bench performance testing should be considered to address preclinical or clinical endpoints,
    when appropriate. This may include bench models for anatomy, such as evaluating tortuous
    paths for catheters used across many clinical applications.”

This draft guidance will replace an earlier guidance document issued in 2002.  The period for public comment on this draft ends on February 13, 2018.

FDA Approves Prickless Glucose Monitoring System

FDA Approves Prickless Glucose Monitoring System

The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients.  The glucose monitoring tool will allow patients to monitor their glucose levels the without painful and inconvenient finger pricks of traditional glucose monitoring.

According to an Abbott press release, the FreeStyle Libre system will allow patients to self-apply the sensor (which is about the size of two stacked quarters) to the back of the upper arm and capture real-time glucose readings with painless scans of a small hand-held reader over the scanner.  This is in contrast to traditional blood glucose monitoring, which may require some patients to finger stick up to 12 times per day.

According to the Centers for Disease Control and Prevention, over 29 million Americans have diabetes.  The FreeStyle Libre system, which became available by prescription from most retail pharmacies in the U.S. by the end of 2017, should enable patients to better manage their disease.  Healthline reports that the product has been available for several to patients in other areas of the world.  Dr. Maria Tulpan of Lenox Hill Hospital in New York, NY commented:

What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.

Abbott states that the FreeStyle Libre Flash Glucose Monitoring System is based on proprietary technology and lists over 50 U.S. Patents issued to Abbott Diabetes Care, Inc., that is believes are associated with the device.  Representative examples include U.S. Patent Nos. 8,889,305, 9,000,929, and 9,014,774.

FDA Pre-cert Program for Lab-Developed Tests

FDA Pre-cert Program for Lab-Developed Tests

The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests themselves.  The American Clinical Laboratory Association describes LDTs as:

[T]ests that hospitals, academic, and clinical laboratories develop as testing services according to their own procedures.  These tests are often created in response to unmet clinical needs, and are commonly used for early and precise diagnosis, monitoring, and guiding patient treatment.

The organization believes that the ability to innovate and design custom diagnostic tests has been critical to the growth of personalized medicine and keeping pace with the changes in the medical profession.

According to Sean Khozin, associate acting director of the FDA’s Oncology Center of Excellence, the program will be modeled after the FDA’s pilot approval process for digital health products. This process functions as a stamp of approval by the FDA, Mr. Khozin explained that:

The precertification program represents a modern approach to regulation, shifting the focus from the product, to the developer of the product . . . .  That product then doesn’t necessarily have to go through analytical validation process.

This program may be compared to to the Digital Health Software Precertification (“Pre-cert”) Program that was announced in July, 2017.  The agency picked nine companies for the program, including Alphabet Inc. (Google’s parent company), Apple Inc., and Fitbit Inc. Under the Digital Health SOftware Pre-cert program, the FDA will examine the software (rather than the device itself) and inspect facilities to ensure they meets the FDA’s standards.  If the companies pass the audit, the companies will attain pre-certified status and their products will be pre-cleared in lieu of being examined by the FDA’s traditional regulatory framework.

Regulating LDTs has been an issue that the FDA has considered in response to a “boom” in the diagnostics industry and as more physicians demand complex tests to screen for diseases like breast cancer and Alzheimer’s.

The medical device and clinical laboratory industries have been at odds over the question of LDT regulation since 2014, when the FDA first sought to regulate LDTs.  Device makers supported the FDA’s regulation-based approach while clinical labs, which were already regulated by the Clinical Laboratory Improvement Amendments (CLIA) under the Centers for Medicare & Medicaid Services, disagreed.  The FDA dropped its enforcement proposals in 2016.  The American Clinical Laboratory Association, whose members traditionally have been regulated under CLIA, said:

[The ACLA] has consistently maintained that LDTs are not medical devices and cannot be regulated as such. The decision by the FDA last year to not issue final guidance to regulate LDTs was a victory for diagnostic innovation and for patients.

The FDA is now expected to announce a new pilot plan soon to certify laboratories that develop diagnostic tests in lieu of drafting rules for the tests themselves. The plan for the LDTs do not seem to conflict with CLIA rules as the CLIA rules does not concern manufacturers, the CLIA rules concern labs.

 

 

FDA Announces Plans for Alternative Clearance Pathway

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in patient care.

According to Commissioner Gottlieb, the FDA regulatory processes for medical devices have remained relatively unchanged for over 40 years.  Under a commonly used clearance pathway, device manufacturers are required to submit a Premarket Notification, known as a 510(k).  The 510(k) constitutes a premarketing submission demonstrating substantial equivalence of a new device to a similar, legally marketed “predicate” device.  The FDA explains that the submission allows the FDA to determine whether the device is as safe and effective as an equivalent device already placed into one of the three FDA classification categories.

However, Commissioner Gottlieb believes that “there are an increasing number of cases where this basic framework isn’t well-suited to reflect the innovation that we see today in certain technologies, and how we must evaluate those technologies.” Similarly, he states that the current 510(k) requirements fail “to realize the full potential of the FDA’s consensus standards program, which was established through the Food and Drug Administration Modernization Act of 1997, and will be refined and expanded as a result of provisions in the 21st Century Cures Act of 2016.” To address these shortcomings, the FDA plans to offer an alternative pathway for demonstrating substantial equivalence in a 510(k) submission.

Under the new pathway, Commissioner Gottlieb states that manufacturers could obtain clearance without direct comparison testing to a predicate device.  Instead, substantial equivalence could be established by meeting objective safety and performance criteria, including FDA-recognized standards, FDA-developed guidance documents, or a combination of the two. The pathway would only be available for pre-specified categories of mature devices – those for which safety and performance criteria that meet or exceed the performance of existing, legally marketed devices can be identified.

Commissioner Gottlieb believes that this alternative pathway:

[H]olds tremendous promise to further streamline device review for sponsors and FDA and allow new innovations to get to patients more quickly; to allow more advanced technologies to be efficiently incorporated into new devices; and to foster greater confidence in the FDA’s ability to efficiently evaluate safety and benefits of technologies cleared under this pathway – all while maintaining the same gold standard that we apply to existing review processes.

The FDA will release its draft guidance on the new 510(K) pathway in the first quarter of 2018.

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system (the “IlluminOss System”).  According to the FDA, the de novo clearance is reserved for new, novel devices whose type has not been previously classified.

IlluminOss, a privately held commercial-stage medical device company based in East Providence, Rhode Island, describes itself as being involved in the development and commercialization of minimally invasive fracture fixation techniques.  The company explains that the newly-approved IlluminOss Bone Stabilization System is used for the treatment of impending and actual pathological fractures of the humerus, radius, and ulna resulting from metastatic bone disease.

Traditional bone stabilization procedures utilizing invasive techniques and intramedullary rods can risk causing extensive soft tissue damage and reduced patient mobility.  Moreover, the metal plates and rods may increase patients’ risk of cortical porosis, delayed bridging, and refractures upon removal.  Regarding its IlluminOss System, IlluminOss states:

The IlluminOss System was developed with an aim to provide improved patient experiences and outcomes when treating pathologic fractures. There is a critical need to make less invasive orthopedic fracture repair options available to an aging and underserved market segment.

In contrast to traditional fixation techniques, the IlluminOss explains that its System uses a small-diameter PET balloon and visible light fiber, each of which may be threaded through a 4.5 mm pathway into the medullary canal through a small incision in the patient’s skin.  Once inserted, the PET balloon is filled with a photoactive liquid monomer, causing the balloon to expand and conform to the specific shape of the patient’s bone.  With the liquid-filled balloon in place, the photoactive monomer is polymerized utilizing the visible light fiber, resulting in a hardened implant which conforms to the patient’s specific bone structure within 90 seconds.  The hardened implant stabilizes the fracture by providing both longitudinal and rotational stability across the length of the implant.

The IlluminOss System has been available internationally since 2010.  IlluminOss reports success in international markets: surgeons have reported smaller incisions, shorter procedure times, and a faster return to the patient’s daily living activities.  Reduced complication rates, and shorter hospital stays have also been observed.

With marketing clearance in hand, IlluminOss plans to initiate U.S. commercialization efforts in the second quarter of 2018.

Diabetes Monitoring Technology Moving Toward Consumer Convenience

Diabetes Monitoring Technology Moving Toward Consumer Convenience

The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System.  According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via taking fingertip blood samples using a fingerstick.

Traditionally, fingersticks required one to prick their finger to obtain blood droplets for diabetes monitoring devices to work.  The Libre flash instead uses a more discreet method of operation–a small sensor wire is inserted below the skin’s surface which continuously measures and monitors glucose levels.  According to Abbott, a mobile reader is used to measure glucose levels when a user waves the mobile reader above the sensor wire.  It is intended for use in people 18 years of age and older with type I or II diabetes.  After an initial 12-hour acclimation period, it can be worn for up to 14 days.  Because a diabetic patient’s pancreas can not produce insulin, those patients frequently must monitor their blood sugar and regularly inject themselves with insulin when their blood sugars spike.

Bloomberg and Reuters report that other companies have been left behind.  Johnson & Johnson is closing its insulin-pump unit after failing to keep up with Medtronic Plc. DexCom Inc., the current leader in glucose-monitoring systems, which, in turn, lost a third of its market value on Sept. 28 after Abbott’s Libre got approval.

The Centers for Disease Control and Prevention notes that more than 30 million people in the U.S. have diabetes.  People with diabetes either do not make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes).  When the body doesn’t have enough insulin or cannot use it effectively, sugar builds up in the blood.  High blood sugar levels can lead to heart disease; stroke; blindness; kidney failure; and amputation of toes, feet or legs.

According to Bloomberg, “the bulk of the sales are to the 1.25 million American diabetes patients with the most severe form of the disease, type 1.  There’s a larger, mostly untapped market: the about 20 million Americans with type 2, whose body’s ability to use insulin fades slowly over time and who don’t regularly use tools to manage their disease.”

 

 

FDA Clears First Apple Watch Medical Device Accessory

The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand.  According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG within 30 seconds and display the results on the Apple Watch or iPhone.  In conjunction with the KardiaBand, AliveCor is introducing “SmartRhythm, a new feature within the Kardia app for the Apple Watch.” 

Portable EKG readers for smart phones are not new; several are on the market already.  However, none of them can tell the patient when to take an EKG.  The KardiaBand solves that problem.  The combination of the KardiaBand and SmartRhythm will use the Apple Watch’s sensors “to continuously evaluate the correlation between heart activity and physical activity,” and alert the user to take an EKG using the KardiaBand when the “heart rate and activity are out of sync.”  According to Dr. Eric Topol, director of the Scripps Translational Science Institute,

[The KardiaBand] is continuously monitoring your heart rate to let you know if something is potentially off track.  That’s the big difference.

AliveCor eplains that the Kardia app will display the results of the EKG on the Apple Watch and alert the patient if atrial fibrillation (Afib) is detected.  If necessary, the results of the EKG can be emailed directly to a physician.  Dr. Topol believes that this technology will “markedly increase the number of EKGs taken,” which will potentially save lives, because Afib often goes undetected.

The news of KardiaBand’s approval comes within days of Apple’s announcement of the Apple Heart Study in conjunction with Stanford Medicine, which will investigate the detection of Afib using the sensors already embedded in the Apple Watch.  However, in a recent interview, AliveCor’s CEO, Vic Gundotra, distinguished the KardiaBand from the heart rate and activity sensors already found on the Apple Watch:

Apple might be able to say ‘oh your heart rate is high’ …but what does that mean? Does that mean you should go to the hospital? And if you go to the hospital what are they going to do?. Any doctor will say ‘ok come in, let’s get an EKG reading.’ . . . It’s not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play.

AliveCor touts the FDA’s approval of KardiaBand as a reason patient’s can be confident in the results of AliveCor’s mobile real-time EKG technology.  In another interview, Mr. Gundotra stated

The average consumer doesn’t know what a normal sinus rhythm looks like or what atrial fibrillation looks like. Yet the FDA has cleared our individual algorithms.  The consumer can have confidence that this is FDA-cleared. And frankly, we have the clinical studies to prove it.

The results of a recent study showed a 4-fold increase in Afib detection when using AliveCor’s mobile 30-second EKG technology.  That same study showed that when using mobile EKG technology, such as the KardiaBand or AliveCor’s other device, fewer cases of Afib went undiagnosed.

The KardiaBand is available on AliveCor’s website for $199.

FDA Provides Guidance on 3D-Printed Medical Device Products

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices.  The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices currently on the market that are manufactured using 3D printers.  Importantly, many of these devices can be tailored to fit a specific patient’s anatomy.  For example, the FDA has reviewed 3D-printed knee replacements and implants for facial reconstruction.

The new guidance gives the FDA’s recommendations regarding the content of FDA submissions, device testing, and manufacturing considerations for 3D printed devices.

In a press release announcing the new guidance, FDA Commissioner Scott Gottlieb stated:

[This guidance] will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.

The new guidance comes on the heels of recent FDA approvals for several 3D-printed devices, including Medicrea’s 3D-printed titanium interbody device for spinal surgery.  The FDA also recently approved a 3D-printed drug tablet, the epilepsy drug Spritam, marketed by Aprecia Pharmaceuticals.

Commissioner Gottlieb further opined that “3D printing is certain to alter the daily practice of medicine where patients will be treated with medical products manufactured specifically for them.”  He noted that 3D printing could one day be used to treat burn patients by printing their own skin cells onto their wounds or used to grow replacement organs.

Commissioner Gottlieb noted, however, that the FDA’s new guidance is intended only “to provide the FDA’s initial thoughts on an emerging technology” and that the FDA’s recommendations likely will change as 3D-printing technology develops.