The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Dune Medical Devices has announced it has received a favorable recommendation from an FDA advisory panel for its MarginProbe System for use in breast cancer surgery, according to a news release. The ...
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CSA Medical submits application to FDA for RejuvenAir System
The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.
The FDA has approved ProlivRx, the first prescription, home-based brain neuromodulation therapy, as an adjunctive treatment ...
Enterra Medical, Inc., today introduced Enterra ReliaStim®, a new stimulation lead designed to make Gastric Electrical ...
In a recent interview, Food and Drug Administration Commissioner Marty Makary declared that Medicare should automatically cover FDA-designated breakthrough devices — a rare and refreshing commonsense ...
Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...
U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as recent layoffs have reportedly had ...
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
Stereotaxis plans to launch the MAGiC cardiac ablation catheter in early 2026, CEO and Chair David Fischel tells MassDevice.
The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen ...
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