Brian Bossetta

Brian Bossetta

Senior Writer

New York, NY

After moving to New York from his hometown of New Orleans, Brian worked on the East End of Long Island covering news, politics and the military. He has since covered the diamond and jewelry industries and most recently pharmacy and health care. His experience also includes freelance reporting and photography contributed to the New York Times. Brian holds a BA in history from Loyola University of New Orleans, is a die-hard Saints fan, and loves running, classical music and jazz. He lives with his wife, Caroline, in New York’s magnificent Hudson Valley.

Latest from Brian Bossetta

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

FDA Blocks Some Olympus Endoscopes From Entering US

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics