Brian Bossetta is a Senior Writer at Informa. He specializes in medicine and healthcare, with a focus on medical technology, healthcare technology, and wellness, covering topics such as medical equipment innovations, digital health, telehealth, consumer health, and mental health. Brian's work has been featured in Citeline and other prominent publications.
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Brian Bossetta's focus is on healthcare and pharmaceutical, with a strong emphasis on regulatory developments and government announcements in the medical devices sector. His coverage suggests he would be most responsive to pitches offering expert commentary or insider insights related to FDA regulations, medical device recalls, or legal policies affecting the healthcare industry.
Given his extensive coverage of government announcements and legal policy regulation, sources who have direct knowledge of evolving FDA guidelines or specific cases related to medical devices may find success in pitching their expertise for commentaries or insights into ongoing issues within the healthcare industry.
It's worth noting that Brian does not appear to have a specific geographic focus but rather covers national as well as international news pertaining to healthcare regulations.
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By: Brian Bossetta, Jul By
Danaher's 2Q 2026 results beat Wall Street expectations and allowed the company to raise its full-year EPS guidance, buoyed by strong life sciences growth and the Masimo acquisition. However, shares dropped on a narrower core revenue growth outlook driven by bioprocessing shipment delays.
By: Brian Bossetta
Speed, predictability, and investment in emerging technologies are the hallmarks of the proposed MDUFA VI commitment letter, which stakeholders describe as the product of the smoothest round of negotiations in memory. FDA will hold a public meeting on Aug. 5 before finalizing the agreement.
By: Brian Bossetta, Jul By
The US Food and Drug Administration has approved SimpleScreen CRC, a blood-based colorectal cancer screening test developed by Freenome that Abbott will exclusively commercialize in the US for average-risk adults aged 45 and older. The test detects cell-free DNA signals linked to colorectal cancer.
By: Brian Bossetta, Jul By
Abbott has launched a post-market study to gauge the safety and real-world performance of its TriClip transcatheter edge-to-edge repair system for treating tricuspid regurgitation. The five-year study will enroll some 1,000 patients across 100 sites in North America and Europe.
By: Jul By, Brian Bossetta
The Food and Drug Administration will increase user fees for most medical device submissions by nearly 10% in FY 2027 under its annual MDUFA fee schedule, with the annual establishment registration fee rising nearly 21% from FY 2026.
By: Brian Bossetta
CMS finalized a 2.3% FY2027 inpatient payment rate increase and eliminated the alternative NTAP pathway for FDA breakthrough devices, while delaying the CJR-X joint replacement payment model to Jan. 1, 2028.
By: Brian Bossetta
The FDA has issued an early alert concerning certain Becton Dickinson Intraosseous Vascular Access System Needle Sets. The agency said 45 serious injuries and four deaths have been associated with the recalled sets, which provide temporary vascular access during emergencies.
By: Marion Webb, Brian Bossetta, Shubham Singh
Science Corp.'s PRIMA brain-computer interface receives CE mark for restoring central vision in AMD patients. Viz.ai partners with Cortechs.ai on MS tracking. AMA urges Congress to regulate mental health AI chatbots. MedLink earns Mayo Clinic Platform qualification.
By: Brian Bossetta
BD reported a strong third quarter, saying its first full quarter as the “New BD” exceeded expectations. The company raised its full-year guidance citing momentum in GLP-1 drug delivery, advanced patient monitoring, PureWick and advanced tissue regeneration, and highlighted several product launches.
By: Brian Bossetta
ACLA's Susan Van Meter argues that PAMA's flawed data pushed Medicare lab reimbursement below market — and that the bipartisan RESULTS Act would fix it by using a qualified independent claims database to set payment rates while limiting future reimbursement cuts to 5%.
