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 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.
Latest From Brian Bossetta
FDA Publishes Guidance On Radiology Images And Device Data For Submitting 510(k)s
The US FDA has updated guidance on computer-assisted detection devices that was first released in 2012. The document, which is intended to help developers win FDA approval of their products, was last updated in 2020.
Potential Pump Malfunction Results In Class I Recall For LifeSPARC Circulatory System
The US FDA has labelled a recall of several hundred components of the LifeSPARC circulatory support system from LivaNova as class I, the agency’s most serious recall designation.
FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs
As part of a policy revamp, FDA encourages COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.
FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs
As part of a policy revamp, the US FDA is encouraging COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.
Another Class I Recall For Philips BiPAP Machines
The US FDA has labelled as class I an August recall of Philips Respironics BiPAP machines due to the potential of hazardous chemicals being inhaled by the user or shutting down the machines.