The Trump administration applied a 90-day hold on nation-specific tariffs, but a group of 26 House Democrats urged the administration to think carefully before acting on a threat to impose tariffs on pharmaceuticals.
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.
Researchers from the University of Cincinnati filed for protection of an electrochemical aptamer-based biosensor technology with improved sensitivity and longevity, which has the potential for monitoring several biomarkers over sustained periods.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Chemeleon, Drummond, GE Healthcare, Innoblative, Nextech, Ocuco, Ondine, Prapela.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Cynosure, Dexcom, Intuitive.
“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.
Boston Scientific Corp.’s up to $664 million acquisition of Bolt Medical Inc. closed just days after Bolt secured U.S. FDA 520(k) clearance for its intravascular lithotripsy (IVL) system, positioning Boston Sci to challenge Johnson & Johnson’s Shockwave IVL system, which has been the only player in the market.
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.