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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As part of its Home as a Health Care Hub initiative, the US FDA's device center has unveiled an Idea Lab that includes a virtual reality experiencing offering an inside look at what is possible for patients receiving care at home utilizing the latest digital technologies.
The US FDA has published a draft guidance document for developers of AI-enabled medical devices describing the postmarket management of their products. The guidance offers a comprehensive approach to the management of risk throughout the total product life cycle of a device.
By: Brian Bossetta
The US FDA has finalized guidance on notifying the agency of potential device shortages during or prior to a public health emergency. The document includes a list of devices that manufacturers must notify the FDA of when they are in short supply. The guidance also clarifies that device makers voluntarily notify the agency of potential supply chain disruptions at any time.
By: Brian Bossetta
The US FDA final guidance uses a Q&A format to help manufacturers navigate the regulatory landscape for communicating the off-label uses of their medical products to health care professionals. However, some say the final document fails to address potential free speech concerns.
A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.
The director of the US FDA's device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.
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.
By: Brian Bossetta
Sara Brenner, a preventive medicine and public health physician at the US FDA who served in the first Trump administration, has been named the agency's acting commissioner.
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