Siemens Healthineers AG has received CE mark for a neurofilament light chain assay to help with the early diagnosis of multiple sclerosis and aid in predicting the risk of relapse in patients suffering from the disease. The test developed in collaboration with Novartis Pharma AG will be launched in Europe later this year. Read More
For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device. Read More
Criticisms over the U.S. FDA’s use of advisory committees led the agency to hold a June 13 public hearing during which FDA commissioner Bob Califf said the agency is working to improve the experience of special government employees who take part in these hearings. Read More
With all the criticism the U.S. NIH has been getting of late, it’s not surprising that yet another reform proposal for the research agency is brewing in Congress. In unveiling a proposed framework to reform the NIH, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) recognized the critical role the agency plays in life-saving medical research and innovation. Read More
Elutia Inc. received U.S. FDA clearance for its antibiotic-eluting bioenvelope. Designed to prevent post-operative complications from the implantation of cardiac devices such as pacemakers and defibrillators, Elupro (formerly Cangaroo RM) combines slow release of the antibiotics rifampin and minocycline with a biomatrix that stimulates regeneration of a tissue pocket to surround and protect the device. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardioflow, Elutia, Philips, Siemens. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bicycle Health, Bluejay Diagnostics, Co-Diagnostics, Glaukos, K2 Medical, LED Radiofluidics, MGI, Neuromod, Opiaid, Premium Imaging, Seqone, Shangkang Life Science, Shineco, Turing Video, Vapotherm. Read More
