Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asensus, Aerwave Medical, Alkem Medtech, Edge Medical, Exactech, HTEC, Kane Biotech, Karl Storz, Lindus Health, Lucius Partners, Maui Imaging, Microbot, Neuroxt, Podimetrics, Stratus Medical, Trudell, Vyaire, Woebot Labs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atricure, Clarity, Rehabtronics, Sibel Health.
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
Cresilon Inc. secured U.S. FDA clearance for Traumagel, a hydrogel that stops potentially life-threatening bleeding in seconds. Cresilon designed the product for use by the U.S. military, first responders and medical professionals to swiftly and effectively stop bleeding from traumatic wounds
Algodx AB received U.S. FDA 510(k) clearance for its sepsis detection software Navoy CDS. The technology, which analyzes patient data, has the potential to improve patient outcomes as it enables clinicians to detect and treat sepsis earlier.
The U.K. Medicines and Health Care Products Regulatory Agency enacted its AI Airlock program for artificial intelligence – the agency’s branding for its regulatory sandbox for this type of medical software.
The U.S. FDA’s effort to regulate lab-developed tests was predictably controversial, but the final rule drew a second lawsuit, this time from the Association for Molecular Pathology.
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