The device, Varipulse, is a pulsed field ablation system which uses small burns or freezes to cause some scarring in the ...

Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...

Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...

Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock ...

Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

There are now artificial intelligence programs that scan MRIs for signs of cancer, Apple AirPods that work as hearing aids ...

Tarver, an ophthalmologist, replaces longtime CDRH Director Jeff Shuren, who announced his retirement in July.

Also known as a polymyxin B haemoperfusion (PMX), Toraymyxin is a haemoperfusion device that removes endotoxin, a toxic ...

NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve ...