Blog Category: Blog

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

PTAB Institutes Inter Partes Review of Medtronic “Jervis” Patent

On June 11, 2019, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) instituted inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc.  The Decision instituted the IPR based on

New Motion Sickness Glasses Launched

New Motion Sickness Glasses Launched

In July 2018, Citroën, the French car manufacturer, unveiled glasses that aid in alleviating motion sickness.  The “Seetoën” glasses, developed by Boarding Ring, purports to eliminate motion sickness symptoms within about 10

Boston Scientific Exercises Option to Acquire Transcatheter Annuloplasty Ring Developer Millipede Inc.

Global medical device company Boston Scientific has announced on December 27, 2018, that it exercised its option to acquire remaining shares of privately-held medical device company Millipede, Inc. upon its recent successful

A New Weapon against Obesity

A New Weapon against Obesity

A new study based on a novel implantable weight loss device that was published in Nature, has shown that it was able to help rats shed almost 40 percent of their body weight.  This implant device developed by engineers at the University of Wisconsin–Madison

Medical Research Organization NAMSA Announces Acquisition of Reimbursement Strategies Consultancy

Medical Research Organization NAMSA Announces Acquisition of Reimbursement Strategies Consultancy

NAMSA, which describes itself as “the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services,”

Garmin and ActiGraph Collaborate to Explore Health and Activity Monitoring Solutions on Wearable Devices

Garmin International, Inc. recently announced a collaboration with ActiGraph to create health and activity monitoring solutions for academic research, clinical trials, and remote patient monitoring.  The collaboration will combine

Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic “Jervis” Patent

Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic “Jervis” Patent

On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc.  The ‘141 Patent is entitled “Medical

FDA Clears Mobile Medical Application for Patients with Opioid Use Disorder

On December 10, 2018, the U.S. Food and Drug Administration (FDA) announced that it granted clearance of the reSET-O™, a mobile medical application to help increase retention of patients with Opioid Use Disorder (OUD) in an outpatient

FDA Plans Overhaul of 510(k) Clearance Program

Recently, the U.S. Food & Drug Administration (FDA) announced plans to modernize FDA’s 510(k) clearance pathway, which was adopted more than 40 years ago.  The FDA stated that the plans are aimed at continuing to ensure that

Abbott Obtains FDA Approval for HeartMate 3 Device

Abbott announced on October 19, 2018 that its HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. Physicians

Benchmarking Quality Assurance

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

FDA Launches ‘Quik’ 510(k) Review Pilot Program

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

Apple’s Latest Watch Receives FDA Approval For ECG Functionality

Apple’s Latest Watch Receives FDA Approval For ECG Functionality

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,

First CBD Drug Receives FDA Approval

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

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

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

FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence

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

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

Boston Scientific Buys Venous-Stent Maker VENITI

Boston Scientific recently announced an agreement to acquire privately-held VENITI, Inc. for $160 million. According to the press release, VENITI submitted a pre-market approval application with the U.S. Food and Drug Administration

BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac ablation