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Brian Bossetta

Senior Writer, US Policy & Regulation

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

Rise In Class I Device Recalls A ‘Grave Concern,’ Says FDA’s Anne Reid

The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.

FDA Recalls

Shuren Says CDRH Is ‘Turning The Ship Around’ As Operations Return To Normal

The director of the US FDA’s device center discussed several of the center’s priorities at Medcon, such as moving beyond the pandemic, focusing on patients, and advancing health equity.

FDA Regulation

Alarming Rise Of Diabetes in Several US States, Study Shows

A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.

US States Diabetic Care

News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR

This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.

News We're Watching Approvals

FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

FDA Evaluate Data

Israeli Company Lands De Novo Clearance For Digital Bone Marrow Application

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

FDA Diagnostics
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