FDA Publishes New Monkeypox and Medical Devices Web Page
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes information on diagnostic testing, Laboratory Developed Tests (LDTs), and information for test developers. With more than 22,000 confirmed Monkeypox cases in the U.S., the new Monkeypox Medical Devices web comes as FDA takes significant actions to increase Monkeypox testing capacity nationwide following the Secretary of Health and Human Services’ August 9th announcement of public health emergency.
The FDA’s guidance issued for test developers under Policy for Monkeypox Tests to Address the Public Health Emergency describes, among other things, review priorities of Emergency Use Authorization (EUA) requests for monkeypox diagnostic tests. And, on the same day as the FDA guidance was issued, the FDA also issued the first EUA to a commercially available monkeypox test in the United States to Quest Diagnostics for its Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR device. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus,” said Jay G. Wohlgemuth, M.D., Senior Vice President, R&D, Medical and Chief Medical Officer, Quest Diagnostic.
Quest Diagnostics is not the only company that has been working on monkeypox diagnostic test kits. Earlier in June, Becton Dickinson announced partnership with CerTest Biotec to collaborate on molecular diagnostic test for monkeypox. Several other healthcare and pharmaceuticals companies have also been linked with this effort. This comes at a time when many of these companies are preparing for a drop in revenue from COVID-19 testing as the threat of COVID-19 reduces.
FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.
The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.” According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”
Now, two recent guidance documents issued by the FDA allow for altered 510(K) approaches for certain medical devices. The first guidance, issued September 13, 2019, is for a “Special 510(K) Program.” The FDA describes this program as “an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).” The guidance is intended to clarify “the types of technological changes appropriate for review as Special 510(k)s.” The new guidance also supersedes prior FDA guidance from 1998 regarding Special 510(k) policy in “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”
This MDDI article purports to offer a “handy checklist” to determine “if changes made to your medical device can be reviewed under the [Special 510(K)] program.” Some of the questions listed on the article’s checklist include the following:
- Is it a change to the manufacturer’s own device?
- Are performance data needed to evaluate the change?
- Is there a well-established method to evaluate the change?
- Can the data be reviewed in a summary or risk analysis format?
The second FDA guidance, also issued September 13, 2019, is for the “Abbreviated 510(K) Program.” The FDA describes the program as “an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s)” and that “uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.” The guidance is “intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.”
A copy of the guidance for the Special 510(K) Program can be found here, and a copy of the guidance for the Abbreviated 510(K) Program can be found here. The FDA currently states that comments on either guidance may be submitted at any time. Public comments on the guidance for the Special 510(K) Program may be submitted here and for the Abbreviated 510(K) Program here.
BrainsWay Deep TMS System Receives FDA Clearance for OCD Treatment
Israel-based BrainsWay recently announced the de novo FDA clearance of its Deep Transcranial Magnetic Stimulation (TMS) system for treatment of obsessive compulsive disorder (OCD).
According to the press release, the BrainsWay Deep TMS system was previously cleared for treatment-resistant major depressive disorder in 2013, and this month’s de novo clearance is the second indication granted for the device, and marks the first clearance of a non-invasive device for treatment of OCD. The BrainsWay press release further notes that the Deep TMS system’s H7-coil targets the anterior cingulate cortex, which is known to play a role in the pathophysiology of OCD. BrainsWay stated that Deep TMS treatment, which uses changing magnetic fields to stimulate nerve cells in the brain, is non-invasive and has been shown to be safe and well-tolerated by patients.
BrainsWay plans to offer its OCD treatment both in new installations and as an upgrade to its existing systems. Addressing the broad future applicability of the Deep TMS system, BrainsWay president and CEO Yaacov Michlin said:
This clearance further establishes Deep TMS as a platform technology that will provide treatments for additional psychiatric indications, subject to successful completion of our currently ongoing multi center studies and regulatory approvals.
Akili Interactive Announces Trial Results for Video Game Treatment of ADHD
Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to file AKL-T01 with the U.S. Food and Drug Administration (FDA) for clearance under the 510(k) medical device pathway as a novel treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD).
According to the article, unlike traditional drug treatments for ADHD, AKL-T01, also known as Project: EVO, is a video game patients play on a tablet device. AKL-T01 uses storytelling and reward
mechanisms, like those found in standard video games, and further uses adaptive algorithms to automatically adjust the level of stimulus up or down to target deficient cognitive neural systems in the brain and meet the specific needs of the patient.
The article further notes that in the randomized, controlled trial, 348 children and adolescents diagnosed with ADHD were evaluated before and after four weeks of at-home treatment with either AKL-T01 or an active control. According to Akili’s press release, children and adolescents who used AKL-T01 showed a statistically significant improvement in attentional functional compared to the children in the active control group. According to Akili, a full analysis of the results is underway and will be presented in upcoming peer-reviewed publications, scientific conferences, and medical meetings.
The use of interactive software as digital treatment is a relatively new trend. The FDA recently approved what it characterized as its first-ever mobile medical application, an application developed by Pear Therapeutics to treat substance use disorders. As reported by Reuters, Akili’s plan to file for FDA approval may pave the way for what would be the first such digital prescription product to tackle ADHD. Considering that Pear Therapeutics was recently selected to participate in the FDA’s digital health software precertification pilot program, the FDA has provided an indication that the agency may be interested in the type of digital therapy treatment Akili claims to offer.
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.
Speedboat RS2 Endoscopic Device Receives FDA Clearance
UK-based Creo Medical recently announced the clearance of its Speedboat RS2 surgical endoscopic device for minimally invasive removal of lesions in the bowel.
According to the press release, the Speedboat RS2 device and the associated CROMA energy platform received premarket clearance through the 510(k) process by demonstrating that the device is substantially equivalent to an existing legally marketed device. According to Creo, the FDA clearance was received earlier than expected. Expected to take roughly six months, the 510(k) process was completed just 49 days after submission.
The Speedboat RS2 device for endoscopic submucosal dissection is said to be the first of several devices planned for use with Creo’s CROMA radiofrequency and microwave generator. According to the announcement, the Speedboat RS2 is intended for removal of early stage cancerous and pre-cancerous lesions, and combines bipolar radiofrequency cutting and microwave coagulation for precise dissection and controlled hemostasis. The combined functionality is said to reduce the risk of puncturing tissue and enhances the safety profile of endoscopic lesion removal. According to Creo’s CEO Craig Gulliford,
Over the coming weeks, we will be looking to bring forward the development of our US capabilities whilst continuing with the promising training programme underway in Europe.
FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements
The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt “should withdraw their submissions.”
According to the Notice, the exemptions from the 510(k) requirements do not apply to other statutory or regulatory requirements. Further, the Notice indicates there are limitations on some of the exemptions. Table 1 in the Notice lists exempt devices that are subject to general limitations of certain sections of the Code of Federal Regulations (CFR). Table 2 lists exempt devices subject to those general limitations and that must comply with partial exemption limitations as indicated in the table. Table 3 lists exempt devices classified as “radioallergosorbent (RAST) immunological test systems” but which are only a subset of all devices in that classification.
The FDA claims the exemptions “will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.” Further, the Notice states, “regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.”
The Notice was published in accordance with procedures established by the 21st Century Cures Act, which was signed into law December 13, 2016. According to the Notice, the 21st Century Cures Act requires the FDA to publish a list of each type of exempt class II device within 90 days after enactment of the Act and at least once every 5 years thereafter. The Notice reflects the FDA’s final determination regarding a proposed list of devices for exemption issued earlier this year. The relevant codified language for each listed device will be amended by the FDA in a “future action.”
Medtronic’s Recent Interactions with the FDA
It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of Medtronic’s recent interactions with the FDA.
First, in early April, the FDA announced that Medtronic was notifying customers of a voluntary field corrective action for its Newport HT70 and HT70 Plus ventilators over the potential for unexpected shutdowns, which it believes are due to software issues in the devices. MassDevice reports that is recalling well over 7,000 of the affected devices.
Next, the FDA cautioned healthcare providers against using Medtronic’s NavLock Tracker with instruments not cleared to be used with the device. The NavLock Tracker is an accessory to Medtronic’s StealthStation navigation system for use during spinal fusions. As a result, Medtronic is updating its labels on the devices to indicate that only Medtronic instruments should be used.
In early May, Medtronic received official FDA approval for a new drug-eluting stent (DES) known as Resolute Onyx. According to FierceBiotech, the stent is formed from a single strand of a cobalt alloy wire with a platinum-iridium core and can provide physicians with stent sizes up to 4.5-mm and 5.0-mm. This newly approved stent is available for use in the United States, Europe, and countries that recognize the Conformité Européene (CE) mark.
In addition, Pat Shrader, Medtronic’s Vice President of Global Regulatory Affairs, appeared on Capital Hill to request changes in device manufacturing facility inspections by government officials due to the short notice that the manufacturing facilities receive prior to inspection. Shrader was speaking on behalf of the Advanced Medical Technology Association, which includes other companies such as 3M, St. Jude Medical, and Boston Scientific. Ms. Shrader called for standardization of inspections by the FDA.
Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza
Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor. The results are based on a collaborative effort between Myriad Genetics and AstraZeneca for identification and treatment of patients with metastatic breast cancer and underlying BRCA 1/2 mutations.
In 2014, the FDA approved the use of BRACAnalysis CDx to identify patient with advanced ovarian cancer that would benefit from treatment with olaparib. Jonathan Lancaster, the chief medical officer of Myriad Genetics stated that, “we believe the results of the OlympiAD trial support use of BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing.”
The recent announcement is the first report of data from a Phase 3 Clinical Trial (the OlympiAD trial) that compares treatment options in Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations. The treatments compared the responses to Lynparza and so-called physician’s choice chemotherapy, where the investigators will choose Capecitabine, Vinorelbine, or Eribulin. Mydriad’s BRACAnalysis CDx test was used to identify patients with germline BRCA 1/2 mutations and these patients showed a statistically-significant improvement of progression-free survival when treated with olaparib compared to treatment with a chemotherapy of the physician’s choice. Information about the clinical trial can be obtained here: https://clinicaltrials.gov/ct2/show/NCT02000622.
According to Myriad, BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variations of BRCA1 and BRCA2 in both protein coding and intron/exon junctions regions of the genes. The device analyzes genomic DNA obtained from whole blood. Small genetic variations including single nucleotide polymorphisms (SNPs) are identified using PCR with Sanger sequencing. Larger genetic variations, including large deletions and duplications, are detected using multiplex PCR.
FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring
The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new report issued by the NEST Planning Board. The Planning Board was convened by the FDA and the Duke-Margolis Center for Health Policy in order to outline the initial priorities for NEST.
The FDA plans for NEST to be the national evaluation system for medical devices and is aiming to evaluate evidence from the entire life-cycle of medical device products in order to more effectively monitor medical device safety and efficacy.
In July, FDA Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health (CDRH) stated that this system for evaluating health technology:
could quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.
The Planning Board’s report explains that new standards for sharing medical data between multiple entities will be the focus of a planned NEST Coordinating Center. The proposed Coordinating Center will work to develop a network of experts which will aid NEST in collecting and evaluation clinical data, as well as data received directly from patients. According to the report, the Coordinating Center will foster the development of a NEST clearinghouse of analytical tools, methods, and standards for using linked real-world data collected through clinical and administrative workflows as well as from patients themselves to evaluate devices.
FDA Issues Proposed Guidance for Changes to Medical Device Software
The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software changes to the FDA for approval. The final document will provide assistance to medical device companies and the FDA for determining when changes to software or firmware for a medical device require FDA clearance. The medical devices covered include 510(k)-cleared devices and preamendments devices subject to 510(k).
The FDA’s proposed guidance explains that premarket notifications are generally submitted for commercially-distributed medical devices undergoing significant changes in design. Such changes include modifications that “could significantly affect the safety or effectiveness of the device” or a “major change or modification in the intended use of the device.” The proposed guidance relates to software changes and is an update to the original guidance issued in 1997 regarding changes to existing devices.
The “software” subject to the proposed guidance is defined as “electronic instructions used to control the actions or output of a medical device, to provide input to or output from a medical device, or to provide the actions of a medical device.” This includes software embedded in a device, software that is an accessory to another device, and “software that is intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.”
The FDA provides a flow chart for assisting with the determination, see below. Issues addressed in the determination include changes related to: strengthening cyber security; meeting specifications of the most recently cleared device; introducing or affecting hazardous situations; creating new risk control measures; and affecting clinical functionality or intended use of the device. Additional factors to consider beyond those in the flow chart and some examples of modifications are provided in the draft guidance as well.
The proposed guidance notes that in some cases a new 510(k) is not necessary, and that existing Quality System (QS) requirements may suffice. Such QS requirements mandate, among other things, that the manufacturer maintains records, for production upon request, regarding such changes and the processes used to determine the changed device meet the design specifications. Further, the proposed guidance does not apply to software for which the FDA has previously said it will not enforce compliance, including some mobile apps used with medical devices.
Some observers think the proposed guidance will help with improving cybersecurity of connected medical devices. The public may provide comments to the FDA on the proposed guidance until November 7, 2016: comments may be submitted electronically here.
FDA Approves AspireAssist Obesity Device
On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal. According to a press release by the manufacturer Aspire Bariatrics, the AspireAssist System is an endoscopic alternative to weight loss surgery for people with moderate to severe obesity and is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies.
The FDA news release summarized the procedure of installing and using AspireAssist as follows:
To place the [AspireAssist] device, surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen. A disk-shaped port valve that lies outside the body, flush against the skin of the abdomen, is connected to the tube and remains in place. Approximately 20 to 30 minutes after meal consumption, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents. Once opened, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet. The device removes approximately 30 percent of the calories consumed.
According to the FDA news release, the FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy and 60 control patients who received only the lifestyle therapy. The lifestyle therapy included nutrition and exercise counseling. After one year, patients who used AspireAssist lost an average of 12.1 percent of their body weight compared to 3.6 percent for the control patients. Clinical trial results also suggested that both patient groups had small improvements in conditions often associated with obesity, such as diabetes, hypertension and quality of life.
A youtube video on the AspireAssist System published by Aspire Bariatrics is attached below:
FDA Approves First App-Based Pacemaker Monitor
Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable pacemakers.
According to Medtronic, the MyCareLink Smart Monitor includes a handheld portable device reader paired with a MyCareLink Smart mobile app on a smartphone or tablet. The portable device reader receives pacemaker data (when placed in close proximity to the implanted device), and communicates with the mobile app on a smartphone. The data can then be transmitted to the patient’s physician or clinic (e.g., through cellular or Wi-Fi service). The MyCareLink Smart Monitor also allows patients to create personal profiles on the MyCareLink Connect Website and receive reminders, confirmations, and notifications about their data transmissions. HIT Consultant reports that the MyCareLink Smart Monitor will allow for faster treatment, reduced time in clinical care facilities, and potential improvements in survival rates.
Regarding the approval, Darrell Johnson, Vice President and General Manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic stated:
“As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare. The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement.”
NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage
Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral bodies damaged by tumors, fractures, or osteomyelitis.
According to NuVasive’s FDA filing, the X-Core Mini system can also be used for reconstruction following a corpectomy or to restore the integrity of the spinal column without resorting to spinal fusion in patients that have short life expectancies due to advanced-stage tumors involving the cervical spine. The X-Core Mini system is available in a variety of sizes and shapes to accommodate differences in individual patients’ physical characteristics and pathology.
NuVasive states that the X-Core Mini must be used with supplemental fixation that has previously been cleared by the FDA for use in the cervical spine, which includes NuVasive’s new Archon Reconstruction Corpectomy plate. This plate is designed to increase rigidity and to resist screw pullout.
In a company news release NuVasive’s President and Chief Operating Officer, Pat Miles, stated:
The assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive’s commitment to providing single-source, integrated procedural solutions to our customers. Combining X-Core Mini VBR and Archon Reconstruction plate provides another excellent example of defining the components necessary to properly address an unmet market need as NuVasive remains focused on becoming number one in spine.
According to Fierce Medical Devices, NuVasive became the third-largest competitor in the spinal device market last year. NuVasive maintains an active patent portfolio to help protect its market share: the USPTO Assignment Database lists NuVasive as the Assignee of 325 patents and patent applications dating from 1999 to the present.
Shifts in the Regulatory Landscape
Regulatory approval of medical devices is a significant consideration for any innovator or manufacturer of medical technologies. The U.S. FDA’s regulatory approval processes, including, for example, 510(k) clearances and PMA approvals, are notoriously stringent. So stringent is the U.S. regulatory procedure that many medical device companies opt to enter the regulatory process elsewhere before entering the U.S. Europe, with its CE mark, which is commonly felt to be a simpler and more straightforward regulatory process, is a common choice. PR-BG.com reports that, due to several factors, of which regulatory complexity is one of the most significant, only 4% of manufacturers approach the U.S. first for regulatory submission. Conversely, due to the perceived regulatory simplicity in Europe, a staggering 80% of manufacturers approach the European Union first for regulatory submission. Because of barriers to entry in the U.S., such as high regulatory uncertainty, high cost of required clinical trials, long time-to-market, and complexity of the FDA’s approval process, many manufacturers never ultimately approach the U.S. for regulatory approval.
According to PR-BG, the FDA is trying to simplify the U.S. regulatory procedure and improve the perception thereof. As a positive result of the FDA’s efforts, backlogs and decision times have been reduced and approval rates have increased.
While the FDA attempts to make its regulatory process easier to navigate, the Irish Times reports that the EU is now attempting to tighten its medical device regulations. Proposed changes to the regulation of medical devices in the EU are currently being considered and have just come through the European Parliament. Such beefed-up regulations could very well increase the difficulty and cost of getting products from bench to the European bedside. Bill Doherty, Vice President of Cook Medical’s Europe, Middle East and Africa divisions states that Europe is an attractive development center for medical device companies, such as Cook, because in Europe companies can get their products to market about three years sooner than in the U.S. and Japan. Were the proposed regulations to become law, the European regulatory timeline and costs would likely both increase, thereby giving medical device companies serious cause to consider pulling development and manufacturing out of Europe. According to Doherty, the proposed laws would ultimately stifle Cook’s and other manufacturers’ innovation plans.
As the EU considers making its regulatory process more stringent and the FDA looks to make its regulatory process more accessible, we may begin to see initial filings occurring with increasing frequency in the U.S. and a corresponding decreasing frequency in Europe. However, as the U.S. is likely to remain relatively strict in its procedures (despite its efforts to ease the approval procedure), we may ultimately see medical device manufacturers moving to other, potentially more favorable, jurisdictions such as parts of Asia and South America. Only time will tell.
Hacking the Human Body – Medical Device Security
Medical device development, as always, is shooting upwards – and it has just reached the clouds.
According to News Medical, Verizon just announced that it received 510(k) clearance for its Converged Health Management medical device (the first time Verizon has applied for and received FDA clearance). Converged is a remote patient-monitoring medical device based in the cloud and according to the press release should be available in late 2013.
Verizon claims that the new healthcare solution resides in its allegedly “HIPAA-ready cloud” and will provide easy access to nearly real-time patient data from connected medical devices. Theoretically, this will allow nearly constant medical monitoring – for example, you’re driving your car and you begin to display pre-stroke symptoms (which you can’t notice), if you’re hooked up to Verizon’s “HIPAA-ready cloud,” your primary care physician can call you to tell you to make your way to the nearest hospital.
The potential benefits of this technology could be very interesting (it doesn’t take much imagination to think of some). However, there are also potentially significant consequences. Clearance to fully wireless based devices was first granted in 2006. The FDA has recognized that, while it grants clearance to wireless and cloud-based medical devices, such wireless devices may present a significant security risk. On August 13, 2013 (a surprising 7 years after the first wireless based device clearance) the FDA issued “Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff,” a guide that attempts to offer “reasonable assurance of safety.” In recognition of the potential for cyber-attacks on wirelessly connected and internet-enabled medical devices (and the patients connected to them), the Center for Internet Security has publicized a new initiative attempting to better secure such systems from cyber-attacks.
All security systems have vulnerabilities which can be exploited – the question is how small they are and how smart a potential attacker must be to find them. Will Pelgrin, the president and CEO of the Center for Internet Security stated that:
[W]e wanted to be ahead of the curve. Instead of waiting for a major incident to happen, we wanted to provide guidance across the board. . . . As these devices become connected to the internet and networks, they become more than just clinical devices, they become IT systems. As we all know, the weakest node on a network can be your entry point for negative consequences that can affect those devices.
The EE Times points out that many medical devices (which can be connected to networks), such as sport watches, monitoring bracelets, heart rate monitors and pedometers, offer valuable information but would not harm the wearer upon malfunction. However, there are many medical devices which are life-sustaining, such as pacemakers, insulin pumps, defibrillators, and neural implants. If these medical devices were “hacked” through inherent weaknesses or through weaknesses in a node of the network to which they are connected, the consequences could obviously be fatal. According to the article, an insulin pump has already been hacked (by a diabetic white hat hacker demonstrating weaknesses in the system).
ResMed Announces FDA Clearance of Noninvasive Ventilation Device for COPD Treatment
ResMed announced recently that the FDA had recently cleared its home variable positive airway pressure (VPAP) device for treatment of respiratory disorders such as chronic obstructive pulmonary disease (COPD). According to its press release, one in five patients with stage 3 or 4 COPD hospitalized for acute exacerbations are readmitted to the hospital within 30 days, but by providing better at-home care such readmissions can be avoided. Geoff Nelson, ResMed’s Respiratory Care business unit president, states in the press release that:
Minimizing the likelihood of acute events that lead to readmissions starts at the point of discharge, sending patients home with the best tools like ResMed’s VPAP COPD to help them breathe better when their lungs have been damaged by the disease.
According to the press release, ResMed’s device customizes the breath delivered to the patient with a rapid inhalation phase and an extended exhalation phase, which can help enable better gas exchange by overcoming air trapping that is common with COPD patients. ResMed’s press release is available here.
FDA Clearance for Monteris Medical Ablation System
Today’s Medical Developments reports that Monteris Medical‘s second generation MRI-guided ablation device, the “NeuroBlate System,” has just received FDA 510(k) clearance.
According to the press release, the NeuroBlate System combines updated, active MRI visualization and a surgical laser to selectively ablate diseased brain tissue. Monteris Medical’s first generation system has been available in U.S. hospitals since 2010. Regarding its new system, John Schellhorn, President and CEO of Monteris Medical, states that:
Monteris invested significant resources to develop a laser ablation system that is faster and adapts to contemporary clinical workflow. The NeuroBlate System provides neurosurgeons controlled, three-dimensional ablation via a powerful software platform. It supports surgical decision making during brain operations as well as providing post-procedure confirmation of the effects of the thermal therapy.
The press release also indicates that the Cleveland Clinic will soon be adopting Monteris Medical’s second generation NeuroBlate System to treat patients who seek minimally invasive options or are not candidates for traditional surgery.
ABL Medical Launches SilvrSTAT® in U.S.
ABL Medical, LLC has announced the official launch of its SilvrSTAT® Antibacterial Wound Dressing Gel in the U.S.
According to the press release, SilvrSTAT® is based on the company’s patented nano-molecular silver technology and has United States Food and Drug Administration clearance as a 510(k) medical device. ABL Medical states that SilvrSTAT “results in a 32ppm antibacterial wound dressing gel which provides quick and continuous antibacterial activity allowing for efficient wound management” and “has no known or expected adverse events due to the low 32ppm silver concentration.” ABL Medical promotes SilvrSTAT® as inhibiting the growth of a wide range of bacteria, viruses, yeast, and molds in laboratory tests.
The press release is available through Canada Newswire here.
FDA Approves TouchPACS Imaging Software Suite
DMH International announced today that its subsidiary, Touch Medical Solutions, Inc. (TMSI), has received approval from the United States Food and Drug Administration for TMSI’s “TouchPACS” medical imaging software suite. According to the press release:
TouchPACS is a cutting edge software suite for the PACS medical imaging market (Picture Archiving and Communications Systems). The market was valued at approximately $2.8 billion in 2010 and it is expected to grow to over $5.4 billion by 2017 . . . .
The press release states that DMH International, through TMSI, specializes in PACS, electronic hospital records, electronic medical records, personal health records, medical transcription, and paperless medical office solutions. The press release is available here.
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