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
A warning letter from the US FDA citing concerns of some Abbott continuous glucose monitors will not stop the company from launching a novel diabetes sensor later this year as planned.
The US FDA has published its annual international harmonization assessment for fiscal 2025, which reports on the device center’s progress in aligning medical device regulations with global standards to improve patient access to safe, innovative technologies.
The US FDA says Abiomed has reported 22 serious injuries linked to an issue with some of its temporary heart pumps that provide support to patients with acute right heart failure.
The US FDA’s Quality Management System Regulation has officially replaced the decades-old Quality Management System. The new system links with international standards for regulating medical device systems.
The US FDA has granted clearance to eMurmur, broadening the use of its AI-powered software platform. The innovative system identifies primary heart sounds to detect abnormal murmurs as they occur.
The US FDA has published a draft guidance on clinical performance testing and evaluation for premarket submissions from manufacturers of cuffless blood pressure measuring monitors, which the agency generally regulates as class II devices.