Brian Bossetta
Senior Writer, US Policy & Regulation
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
eSTAR Now Open For PMA Submissions
The US FDA electronic submission process for streamlining its product review process is now available for sponsors submitting some premarket approval applications.
FDA Evaluating Safety Of Plastic Syringes From China, May Prevent Their Import To The US
The US FDA is advising the public that certain plastic syringes from China could fail, leak, or break. If necessary, the agency may prevent Chinese syringes from entering the US.
FDA Receives Thousands Of Opinions On Proposal To Regulate LDTs As Comment Period Comes To A Close
As the US FDA works to finalize new regulation of lab-developed tests, it must consider more than two thousand comments that have poured into the agency since the proposed rule was published in October. The comment period closes Monday.
More Nightmares For Philips DreamStation Machines
The US FDA has received a significant increase in medical device reports associated with Philips DreamStation 2 machines, including fire, smoke, and burns.
Founder Of AI Tool For Predicting Progression Of Chronic Kidney Disease Discusses Technology
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.
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.