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FDA Approves Marketing of Self-Fitting Hearing Aid

November 14, 2018 Lindsay Laddaran

The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid.  According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review pathway, is the first approved hearing aid that can be self-fit and adjusted by a user.

FDA & DHS Coordinate Efforts to Address Cybersecurity

October 24, 2018 Albert J. Sueiras

The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities.”

Benchmarking Quality Assurance

October 11, 2018 Mark E. Davis

Best Practices, LLC recently released a study that provides insights into the amount of resources pharmaceutical and medical device companies allocate to ensure their products meet quality and regulatory standards.  The study includes aggregate and anonymized data from 31 large medical companies, including Fisher & Paykel Healthcare, ResMed, Smith & Nephew, and Medtronic, among others.  The majority of the surveyed companies operate primarily in the medical device field, but the data also includes results from diagnostic and pharmaceutical companies.

FDA Launches 'Quik' 510(k) Review Pilot Program

October 11, 2018 Nathan J. Lee

The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third.  The pilot, dubbed as “a Turbo Tax for information submitted in 510(k)s,” by FDA Commissioner Scott Gottlieb, will allow device manufacturers to submit premarket notifications electronically using “eSubmitter” software, as long as the device is classified under one of the specific product codes included in the pilot program and is not a combination product.  In addition to lower risk devices, the pilot program includes some higher risk Class II devices, such as surgical lasers, certain endoscopic equipment, and certain imaging devices (e.g., MRI and stationary X-rays).

Apple's Latest Watch Receives FDA Approval For ECG Functionality

October 11, 2018 Aaron S. Johnson

Since its first release in 2015, the Apple Watch has continued to evolve and incorporate more health- and fitness-tracking capabilities. The latest version of Apple’s Watch—Series 4—features a larger display screen, thinner case, a new interface, and, according to Apple “revolutionary health capabilities.” These health capabilities include electrocardiogram (ECG) functionality, which has been granted approval by the U.S. Food and Drug Administration. Also incorporated into the latest version of the Watch, according to Apple, are a new accelerometer and gyroscope that allow for fall detection.

First CBD Drug Receives FDA Approval

October 11, 2018 Mark E. Davis

The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the United States.  The announcement notes that Epidiolex contains a highly purified form of cannabidiol (CBD), one of many cannabinoids derived from cannabis plants.  CBD, however, lacks the psychoactive properties of its more famous cousin, tetrahydrocannabinol (THC).  The FDA approved the use of Epidiolex for the treatment of seizures associated with several rare forms of epilepsy in patients 2 years and older.

Apple Watch Receives Clearance from FDA as an Over-the-Counter ECG-monitoring Device

October 11, 2018 Sean S. Kim

On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 has been granted De Novo classification by the FDA, which allows Apple to provide its Series 4 Apple Watches as an over-the-counter ECG-monitoring device.

FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence

October 11, 2018 Nathan D. Reeves

The FDA has announced new goals to help modernize its procedures and respond to new technologies.  In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials for medical devices and develop standards for new technologies like artificial intelligence.

BrainsWay Deep TMS System Receives FDA Clearance for OCD Treatment

October 11, 2018 Jordan E. Gottdank

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).

FDA Approves First Generic Epinephrine Autoinjectors

October 1, 2018 Mark Rubinshtein, Ph.D.

he United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors.  According to the press release, Teva’s autoinjectors are the first generic versions of Mylan’s EpiPen® and EpiPen Jr ® to receive FDA approval.

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