Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aethlon Medical, Biorobotics, Carestream Health, Dermtech, Haier Group, Mirxes, Onex, Pie Medical, Shanghai RAAS, Thermo Fisher.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elixir, Roche.
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.
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.
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.
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.
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