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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 US Food and Drug Administration recently updated the labeling of Abiomed’s Impella RP System to reflect the latest results from a clinical study on the device. The FDA first approved the heart pump system in September 2017.

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Some Essential Cardiac Devices In Short Supply, FDA Warns

The US Food and Drug Administration is alerting health care providers that some cardiac devices from a major supplier are in short supply.

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Medtronic Issues Another Recall For The HeartWare VAD System

The latest recall for Medtronic's HeartWare Ventricular Assist Device (HVAD) System was triggered by reports of hardened driveline boot covers, which can make disconnecting the driveline from the controller difficult.

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Temporary Stent To Treat Prostate Enlargement Gets FDA Greenlight

The US FDA has approved a temporary prostatic stent from SRS Medical Systems that allows urine to flow through the urethra when it is blocked by an enlarged prostate.

FDA Regulation

AdvaMed Urges Biden Administration To Use CHIPS To Prioritize Patient Care

Now that the CHIPS and Science Act is law, AdvaMed wants the Biden administration to use it to ensure device makers get the semiconductor chips they need for their products while preventing the US from facing another shortage of the essential components, as experienced during the pandemic.

Medical Device Policy

Compatibility Issues With Some LAV Connectors And Prefilled Syringes Can Interrupt Drug Delivery, FDA Warns

The US FDA says issues with certain LAV connectors attached to prefilled glass syringes may cause clogging and prevent the proper administration of drugs. This could result in serious harm, especially during emergencies.

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