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 Read More

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. Read More

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. Read More

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. Read More

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. Read More

The risk of developing multiple sclerosis (MS) is nearly four times as high for women as it is for men. And that relative risk has increased sharply over time. In 1955, women were only slightly more likely than men to develop MS. A research team at the University of Toronto and the Oklahoma Medical Research Foundation (OMRF) has gained new insights into possible causes for this increasing disparity. Read More

New hires and promotions in the med-tech industry, including: Noscendo GmbH, Qaelon Medical, Quanterix, Trinity Biotech. Read More

Med-tech firms raising money in public or private financings, including: Cairn Surgical, Eyenovia, Precisedx, XII Medical. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Radiation Shield Technologies, Titanflex. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anew Medical, Atrion, Biocardia, Delphinus, Dovetail, Goenomics, Nordson, Quest Diagnostics, Utime. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nano-x, Procept Bioreobotics, Soclean. Read More