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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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The Klinrisk model, a new AI-driven tool developed to predict the progression of chronic kidney disease, proved highly effective in a recent study. The model’s scientific founder told Medtech Insight the novel technology has the potential to help healthcare professionals better identify patients most at risk.

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FDA Leaves Global Harmonization Working Party, Will Focus International Harmonization Efforts

Three years after joining, the US FDA announced its withdrawal from the Global Harmonization Working Party and intention to focus its work on medical device harmonization through its collaboration with the International Medical Device Regulators Forum.

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FDA Issues Final Guidance On Device Shortage Reporting, Adds Device List

The US FDA has published final guidance requiring firms to notify the agency about significant manufacturing interruptions of medical devices during a public health emergency, as well as a supplementary draft guidance that includes a list of specific devices that manufacturers must report to the agency when they are in short supply.

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B. Braun Medical is recalling more than 10,000 pump systems used to deliver drugs. The US FDA has labelled the recall class I, its most serious type, and reported one death associated with the recall.

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Simple 2 Test available OTC as first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV. 

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