AI could significantly improve the value of patient recalls following mammography, but so far radiologists seem reluctant to rely on computer-aided readings. Radiologists tend to trust their own judgment – and that of their colleagues – in mammogram readings far more than AI-based diagnostics, even when the AI is much more accurate, a prospective trial analysis published in Radiology by Karolinska Institutet researchers found.

“We’ve lost 1,000 person-years of expertise in a few weeks,” former U.S. FDA Commissioner David Kessler said in an April 9 House Oversight and Government Reform hearing as he discussed the impact of the termination of 3,500 FDA employees the previous week, on top of the 1,000 who were let go or offered retirement in February.

The U.S. FDA has cleared regenerative medicine company Orthocell Ltd.’s 510(k) for its nerve repair product, Remplir, paving the way to begin commercial operations in the $1.6 billion U.S. nerve repair market.

Some say it’s not what you say but how you say it, but the U.S. FDA’s Feb. 10, 2025, warning letter to Denver-based Exer Labs Inc., makes clear that a 510(k)-exempt device can’t be altered and promoted for claims that are disallowed under the regulation.

The U.S. FDA cleared Artrya Ltd.’s Salix Coronary Anatomy software that analyzes coronary computed tomography angiogram scans via AI to better diagnose coronary artery disease.

GE Healthcare Technologies Inc. gained full ownership of Nihon Medi-Physics Co. Ltd. after acquiring the remaining 50% stake from Sumitomo Chemical Co. Ltd. on March 31.

Two French startups, Gleamer SAS and Azmed SAS, received clearance from the U.S. FDA for their AI-powered tools for chest X-rays. They join an increasing number of companies developing software tools to help clinicians detect a range of abnormalities on images, enhancing diagnostic accuracy, reducing delays and improving patient outcomes.

The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go beyond FDA regulation of clinical lab operations.

As the U.S. Department of Health and Human Services begins implementing its reorganization and reduction-in-force plan by sending out termination notices this week to 10,000 more employees across its agencies, top Democrats in Congress are demanding details about the plan.

Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors.