Brian Bossetta is a Senior Writer at Informa. He specializes in the intersection of medicine and healthcare, focusing on themes such as medical technology, healthcare technology, and public health. His work has been featured in Citeline and highlights critical topics including medical equipment innovations, digital health, and patient care.
Preston is the artificial intelligence that powers the Intelligent Relations PR platform. Meet Preston
United States (National)
Not enough data
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.
This information evolves through artificial intelligence and human feedback. Improve this profile .
By: Brian Bossetta
AdvaMed is urging the US Copyright Office not to renew an exemption allowing independent servicers to repair medical devices. AdvaMed cites intellectual-property, safety and cybersecurity concerns, while Trimedx argues the exemption helps ensure timely repairs and hospitals choice.
By: Brian Bossetta
The US FDA has issued an early alert concerning connectivity issues with the Philips Lumify ultrasound system that may interrupt scans and delay care. The company reports eight serious injuries and four deaths associated with the issue. Philips says it is developing an updated software.
By: Brian Bossetta
The MedTech Conference, hosted by AdvaMed, will bring more than 4,000 industry leaders to Boston Oct. 18–21 to discuss major medtech trends including AI, real-world evidence, regulatory policy, quality systems and global market access.
The US FDA has issued an early alert for some Commander M delivery systems used with Edwards Lifesciences' Sapien M3 transcatheter mitral valve replacement system after reports of balloon ruptures during inflation. The company reports three incidents, including one death and one serious injury.
By: Brian Bossetta
Bipartisan House legislation would exempt ostomy and urological supplies from Medicare competitive bidding for five years, as CMS moves to include them in the program's next round. Groups supporting the bill say these products are unique and not suitable for the program.
By: Brian Bossetta
AdvaMed CEO Scott Whitaker listed tariffs, user fees, reimbursement predictability and strengthening cybersecurity as his top policy priorities during a press conference to lead off the MedTech Conference in Boston.
By: Shubham Singh, Marion Webb, Brian Bossetta, George Underwood
In this week's Digital Health Roundup, BD has struck a $19bn US investment deal for relief from future Section 232 tariffs. UltraSight raises $24m for AI echocardiography, Elixir readies a Japan launch, and Reset Health reports GLP-1 adherence data as it courts NICE.
By: Brian Bossetta
Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in FY 2026 and is rebuilding a workforce that lost around 30% of its reviewers. She said the proposed MDUFA VI agreement is targeted for submission to Congress by January 2027.
Stay ahead in the Medtech industry with expert insights and analysis. Explore trends, innovations, and market intelligence from Citeline's Medtech Insight.
By: Brian Bossetta
Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the new QMSR, emphasizing robust quality systems, proactive FDA engagement and documented corrective actions. They said inadequate remediation can trigger escalated enforcement.
