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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 healthcare. 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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Medical Device Legal Issues

Class I Recall For GE Healthcare CARESCAPE Ventilator

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

FDA Recalls

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The US FDA has granted its breakthrough designation to a virtual reality therapy that recreates everyday scenarios for patients dealing with severe anxiety and schizophrenia.

FDA Approvals

Biden’s Biomedical Research Initiative Moves One Step Closer To Fruition

The US House of Representatives overwhelmingly passed legislation authorizing the creation of a federal health agency to advance biomedical research. The bill now goes to the Senate.

Legislation Innovation

French Company Gets FDA Breakthrough Status For Brain Device

The US FDA has designated Carthera’s SonoCloud-9 as a breakthrough device. The French company’s ultrasound technology is designed to treat a wide range of brain diseases, including recurrent glioblastoma.

FDA Approvals

FDA Issues Final Guidance For Radiological Devices Using Quantitative Imaging

The US FDA has published its final guidance for premarket submissions of radiological devices that use quantitative imaging – technology which offers clinicians a more accurate picture of a disease.

FDA Guidance Documents
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