Artivion has received premarket approval application (PMA) clearance from the US Food and Drug Administration (FDA) for the ...

Artivion AORT recently secured FDA premarket approval (“PMA”) for its AMDS Hybrid Prosthesis to treat acute DeBakey Type I ...

Basics and Beyond - Keeping Up with FDA Medical Device Submission Programs and Pilots” session MEDevice Boston 2026 on August ...

Original premarket approvals are taking “substantially longer” than last year, according to a report from BTIG.

BTIG analyst Ryan Zimmerman said while the increase in approvals is promising, longer decision times may have financial implications.

Artivion, Inc. announced that the FDA has approved the company’s AMDS hybrid prosthesis, an aortic arch remodeling device fo ...

The FDA has issued a warning letter to China-based continuous positive airway pressure (CPAP) device maker BMC Medical.

The regulation of medical devices in the US has grown increasingly complex, with multiple pathways to gain marketplace entry and a shift toward collecting evidence in the postmarket setting. The ...

Over-the-counter continuous glucose monitors have gained popularity over recent years. These devices are designed to help people manage diabetes and other conditions that require monitoring of their ...

Documentation submitted to FDA completing next step in HDE application ・Application enters FDA’s review phase for commercial ...

Please provide your email address to receive an email when new articles are posted on . FDA has approved a portable device for patients with locally advanced pancreatic cancer. A phase 3 trial showed ...