Brian Bossetta
Senior Writer, US Policy & Regulation
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
What We Have Here Is A Failure To Communicate
ECRI says gaps in communication about recalls of medical devices used at homes pose a significant risk to patients. The nonprofit safety organization’s list of the top ten technology hazards for 2023 put lack of communication at the top.
CDRH 2022: Shuren Says COVID-19 Left Agency ‘Battle-Scarred’ But Also Wiser
The US Food and Drug Administration’s device center released its annual report, noting the challenges posed by monkeypox on top of the ongoing COVID-19 pandemic. The report also cites what the center sees as its accomplishments for the year.
Philips Implements Plan To Address FDA Concerns Following Harsh Inspection Report
After a lengthy inspection of a Philips facility that manufactured several recalled breathing and ventilator devices, the US Food and Drug Administration delivered a pointed report to the company highlighting multiple risk management and quality systems issues. In response, Philips wrote to the FDA outlining steps it plans to take to fix the problems.
News We're Watching – 27 January
This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel.
Class I Recall Of Datascope Cardiac Assist Devices
The US Food and Drug Administration has designated a recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps from Datascope/Getinge as class I due to the potential for the pumps to shut down during use.
Medtech Monthly, Ep. 5: Eargo CEO Discusses OTC Hearing Aids
Listen up! In this episode of Medtech Monthly, Eargo CEO Christian Gormsen discusses the newly created OTC category for hearing aids.