Although it does not generally infect humans, a single mutation of the H5N1 virus in the highly pathogenic avian and bovine clade 2.3.4.4b could overcome this barrier and possibly trigger a pandemic. Scientists at The Scripps Research Institute have warned of this possibility after studying the three-dimensional structure of the viral hemagglutinin and seeing how a change in one amino acid would make it more suitable for the human cell receptor. The researchers stress the need to monitor new mutations of this virus in order to act quickly in case the global jump to our species occurs. Read More
The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial changes, some more significant than others. Read More
Nua Surgical Ltd. secured €6.5 million ($6.9 million) in series A financing to support regulatory clearance in the U.S. and early commercialization of its Stericision C-section retractor. The device is a self-retaining surgical retractor designed to improve outcomes for mothers undergoing a caesarean section. Read More
The Biosecure Act missed its expected ride through the U.S. Congress via the National Defense Authorization Act, but it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed “biotechnology companies of concern.” Read More
Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining the Ensuring Patient Access to Critical Breakthrough Products Act for potential passage in the lame duck session – a development that would draw enthusiastic cheers from industry. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptive Biotechnologies, Hologic, NMDP, Precisedx. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anx Robotica, Ceryx Medical, Crossject,Elabnext, Eppendorf, Inspiremd, Lunit, Myome, Natera, Navis, Nightware, Nikon, Setpoint, T2, Wildcat Dx. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiodynamics, Artivion, Copan Diagnostics, Conavi. Read More
