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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.

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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.

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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. 

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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.

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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. 

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FDA Asks For Input On Best Ways To Support Premarket Use Of Real-World Evidence

The US Food and Drug Administration is seeking public comment on how best to allocate funds authorized under the latest installment of the Medical Device User Fees Amendments to support premarket real-world evidence.

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Recall Chances Higher For 510(k) Devices With Recalled Predicates, Studies Show

Two studies recently published in JAMA argue that a higher recall rate tied to 510(k) devices cleared based on also-recalled predicate devices help to demonstrate 510(k) safety concerns.

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