Showing all posts written by Jordan Gottdank
Mr. Gottdank earned his J.D. from UCLA School of Law, where he co-founded the Intellectual Property Law Association and worked as a research assistant in the fields of intellectual property law and international environmental regulation. While in law school, Mr. Gottdank served as a judicial extern for four judges in the U.S. District Court for the Central District of California, working exclusively on patent cases. He has experience in a wide range of fields, including electronics, communications technology, optics, medical devices, transportation, apparel, and sporting goods.
Mr. Gottdank worked as a summer associate at the firm in 2014 and joined the firm in 2015. Click here to read full bio
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.
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.
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.
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.
According to Novocure’s press release, the final results of the EF-14 clinical trial indicated a two-year survival rate of 43% for patients treated with the Optune device in addition to conventional temozolomide (TMZ) chemotherapy, versus a two-year survival rate of 30% for patients treated with TMZ alone. Novocure also reported that the addition of the Optune device to the standard TMZ treatment resulted in a five-year survival rate increase from 5% to 13% and a median overall survival extension from 15 months to 21 months. The press release noted that these results were seen across all patient subgroups, including young versus elderly patients, patients with methylated versus unmethylated MGMT promoter and patients who underwent any extent of tumor resection.
EF-14 Principal Investigator Roger Stupp, M.D., stated:
Now, we see a meaningful improvement in survival at two years and beyond. With the combination of Optune and temozolomide, one out of seven patients is living longer than five years.
Optune is advertised as being a wearable device that uses transducer arrays adhered to the scalp to deliver tumor treating fields (TTFields), a form of alternating electric field therapy, to inhibit division of GBM cells. According to Novocure, Optune has been FDA approved for treatment of newly diagnosed GBM since 2015, and for treatment of recurrent GBM since 2011. According to Novocure CEO Asaf Danziger, the “efficacy shown in EF-14 for GBM gives us hope that TTFields used in combination with other cancer treatments may increase survival without significantly increasing side effects for a variety of solid tumors.” Dr. Stupp added that TTFields “may well be suited for combination with conventional treatments for many other cancer types.”
The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF), an international group of medical device regulatory authorities including the FDA. When finalized by the IMDRF, the draft guidance will represent the FDA’s “current thinking” on SaMD clinical evaluation and will not be binding.
SaMD is defined in the guidance as software that functions as a medical device and can run on a general purpose computing platform, “without being part of a hardware medical device.” Unlike other medical device-related software, SaMD primarily has risks associated with incorrect output affecting clinical management of a patient, rather than risks resulting from direct patient contact. Thus, the guidance is intended to address the “uniqueness of indirect contact between patients and SaMD” and provide globally harmonized principles for establishing scientific validity, clinical performance, and analytical validity for a SaMD.
The FDA is seeking public comment on the draft guidance generally, and related to eight specific issues:
Does the document address the intention captured in the introduction/scope or vice versa?
Does the document appropriately translate and apply current clinical vocabulary for SaMD?
Are there other types of SaMD beyond those intended for non-diagnostic, diagnostic and therapeutic purposes that should be highlighted/considered in the document?
Does the document adequately address the relevant clinical evaluation methods and processes for SaMD to generate clinical evidence?
Are there other appropriate methods for generating clinical evaluation evidence that are relevant for SaMD beyond those described in the document?
Are the recommendations related to the “importance of clinical evidence and expectations” appropriate as outlined for the different SaMD categories?
Are the recommendations related to the “importance of independent review” appropriate as outlined for the different SaMD categories?
Given the uniqueness of SaMD and the proposed framework—is there any impact on currently regulated devices or any possible adverse consequences?
The draft guidance is available for comment until December 13, 2016.
Second Sight announced in a press release the publication of positive results from a long-term clinical trial of the Argus II Retinal Prosthesis System. According to the press release, the five-year trial included 30 subjects who were blind due to retinitis pigmentosa (RP). The results, which will be published in Ophthalmology, indicate that the Argus II device provided improved visual function that was sustained over the course of the trial. The study further reported improved patient well-being and an acceptable safety profile. Will McGuire, President and CEO of Second Sight, said:
“We are excited to see that the substantial visual improvement gained from the Argus II endures over five years – promising news for patients blinded by RP, as well as for our company’s continued efforts to restore vision.”
The Argus II Retinal Prosthesis System assists wearers with RP-related blindness by capturing images using an eyeglass-mounted camera, converting the images to electrical pulses, and transmitting the electrical pulses to the retinal surface. The Argus II system received FDA approval in February 2013, and according to the press release a 2014 study supported the device’s long-term cost effectiveness.
ESDs have been used to reduce or eliminate self-injurious or aggressive behavior by applying an electric shock to the skin. According to the proposal, FDA determined that ESDs “present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.” The proposed rule also cited ethical concerns, as many people exhibiting aggressive or self-injurious behavior are among a vulnerable patient population due to intellectual or developmental disabilities. Such patients may have difficulty communicating pain or consent, and may be unable to make their own medical treatment decisions.
FDA’s “primary concern is the safety and well-being of the individuals who are exposed to these devices,” according to William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in an April 22 press announcement.
“These devices are dangerous and a risk to public health–and we believe they should not be used.”
FDA research indicates that only one facility is using ESDs to treat aggressive and self-injurious behavior in the United States, treating an estimated 45-50 people. Although medical practice has largely evolved toward positive behavioral treatments, sometimes combined with medication, the proposed rule “would ultimately remove these devices from the marketplace completely.”
FDA medical device bans are rare and typically used only when necessary to protect public health. However, the proposed ESD ban follows just one month after a March proposal to ban powdered gloves. The only medical device ban currently in effect was issued in 1983, covering implantable prosthetic hair fibers for concealing baldness.
The proposed rule is available online for public comment for 30 days.
According to its recent press release, Stryker Corporation has reached an agreement to acquire Sage Products, LLC from Chicago private equity firm Madison Dearborn Partners in a $2.775 billion cash transaction. Stryker describes itself as medical technologies company based in Kalamazoo, Michigan, specializing in orthopedic implants for hip, knee, and other replacement surgeries, as well as various medical-surgical, neurosurgical, and spinal technologies. According to its website, Cary, Illinois-based Sage develops products for prevention of hospital-acquired injuries and infections in patients and clinicians. Sage’s products include solutions for oral care, skin preparation and protection, patient cleaning and hygiene, turning and positioning devices and heel care boots.
Kevin Lobo, Chairman and CEO of Stryker, praised Sage’s “established leadership team and innovative products,” which “have driven consistent double-digit sales growth.” According to Lobo, the two companies share a “focus on offering products and services that support a mindset of prevention, specifically in the area of ‘never events’ such as hospital acquired infections.” The acquisition will “provide a consistent disposable revenue stream that will complement [Stryker’s] capital equipment offerings.”
Scott Brown, President and CEO of Sage Products, stated:
Sage is well-positioned for continued achievement and long-term success with Stryker, a company that understands our business, supports our goals and embraces our values.”
The transaction is expected to bring Stryker future tax benefits of over $500 million, as well as approximately 15 years of increased cash flows. According to Bloomberg, Madison Dearborn Partners will gain nearly 320% in the sale, having invested $350 million in Sage Products 3 years ago. The transaction is expected to close in the second quarter of 2016.