Brian Bossetta

Brian Bossetta

Senior Writer

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

US FDA Continues AI Adoption With Agentic Product Roll-Out

With the roll out of agentic AI, the US FDA continues to expand its capabilities, following the launch of Elsa, its generative AI tool in May.

Makary Continues To Seize On AI ‘To Modernize’ The FDA And Accelerate Advanced Treatments

With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.

Stakeholders Tell FDA Real-World Data Essential In Evaluating AI-Device Performance

In September, the US FDA asked the public to weigh in on how AI-enabled medical devices perform in real-world settings. With the comment period now closed, the agency has heard back from dozens of stakeholders on how the agency can use clinical outcomes to better understand these devices.

Hundreds Of Adverse Events, Multiple Deaths, Associated With Abbott Correction Of Libre 3 Sensors

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

LDTs Aimed At Catching Cancers Early Hold Promise In Reducing Late-Stage Diagnoses, Study Shows

A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

FDA Staff Warn Device AI Hallucinations Could Harm Patient Care

Hallucinations are a common problem in AI and pose significant challenges to medical devices powered by the technology. A paper authored by several FDA staffers argues that focusing on how hallucinations impact patients is the best approach.