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Brian Bossetta

Senior Writer, US Policy & Regulation

New York, NY

After moving to New York from his hometown of New Orleans, Brian worked on the East End of Long Island covering news, politics and the military. He has since covered the diamond and jewelry industries and most recently pharmacy and health care. His experience also includes freelance reporting and photography contributed to the New York Times.

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

News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR

This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.

News We're Watching Approvals

FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

FDA Evaluate Data

Israeli Company Lands De Novo Clearance For Digital Bone Marrow Application

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

FDA Diagnostics

More Heartmate Troubles For Abbott. Latest Recall Includes 14 Deaths

Abbott initiated a recall in February of thousands of Heartmate devices due to a system obstruction that can result in serious health outcomes, including death. The FDA has now designated the recall as class I.

FDA Recalls

Mini-Slings Are Comparable To Traditional Ones To Treat Incontinence, FDA Says

The US FDA continues to provide updates on the safety and efficacy of surgical mesh sling procedures, a common surgery to correct stress urinary incontinence.

FDA Post Market Regulation & Studies

News We’re Watching: Lung Preservation System Goes National, De Novo For MMI, Brazil’s ANVISA To Recognize Overseas Approvals

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

Regulation Commercial
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