Brian Bossetta
Senior Writer, US Policy & Regulation
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
Listen Up! Big Things Happening In The World Of Audiology
From innovation to legislation, the US audiology market is being shaped by cutting-edge technology from device makers and legislation from the Biden administration to get more hearing aids to those that need them.
FDA Posts Study Confirming OD Risk From ENFit LDT Syringes
The US FDA has posted a study affirming a safety communication the agency issued in October that warned of overdose risk from certain low dose tip syringes.
FDA Warns Of Severe Risks Associated With Medtronic Leadless Pacemakers
The US Food and Drug Administration has issued a warning to clinicians of the heightened risk for adverse events, including death, from potential cardiac perforation during implantation of Medtronic’s Micra Transcatheter Pacing System (TPS).
Exec Chat: Intricon CEO Bullish On OTC Hearing Aids
Scott Longval, CEO of medical device manufacturer Intricon, says the US FDA’s proposal to allow over-the-counter sales of hearing aids without a prescription will benefit industry as well as those with hearing loss.
FDA Gives Green Light To Non-Opioid Treatment For Back Pain
The US Food and Drug Administration has authorized a virtual reality system for treating chronic lower back pain. EaseVRx uses a virtual reality headset and sound amplifier to assist in breathing exercises aimed at reducing pain.
US FDA Updates Template For OTC COVID-19 Test Development
The US FDA’s most recent update is intended to help test makers provide validation data and other information to the agency for developing at-home diagnostic tests.