Brian Bossetta is a senior writer whose work has been featured in Informa. He covers a range of topics in the medical field, including FDA regulations, recalls and approvals, clinical trials, and medical device safety. With a focus on providing timely and informative news, Brian keeps readers up to date on the latest developments in the industry.
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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
In its inaugural two-day meeting, the FDA Digital Health Advisory Committee discussed the promise of generative AI-enabled medical devices as well as challenges the agency faces in premarket evaluation, benefit/risk analysis, and postmarket monitoring.
The page you’re looking for is not available. Explore Citeline News & Insights for in-depth healthcare information and resources.
The page you’re looking for is not available. Explore Citeline News & Insights for in-depth healthcare information and resources.
During an online seminar Tuesday, the FDA offered guidance on registration and listing requirements for lab-developed tests that will go into effect on 6 May 2026.
Patient safety group ECRI put AI-enabled applications at the top of its annual list of health hazards for 2025. The group says that despite its enormous potential, artificial intelligence presents the most significant risk among health technologies going into the new year.
By: Brian Bossetta
The US FDA has issued its first communication as part of a new pilot program the agency initiated to increase transparency in recalls of high-risk medical devices. The early alerts are meant to minimize the time between the FDA finding out about a potential issue and informing stakeholders.
The page you’re looking for is not available. Explore Citeline News & Insights for in-depth healthcare information and resources.
The medtech industry played a pivotal role in the first Trump administration, most notably during the COVID-19 pandemic. But the sector was also impacted by the administration’s deregulation push and trade posture towards China, including tariffs. So, should stakeholders expect more of the same in a second Trump term, or brace for uncertainty and change?
The page you’re looking for is not available. Explore Citeline News & Insights for in-depth healthcare information and resources.
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