Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cathvision.
Hypothermic therapy startup Tectraum Inc. has finished enrolling patients in a pivotal trial of its Pro2cool device for the treatment of concussion. The company expects to submit the results to the U.S. FDA to support regulatory clearance by the end of this year and commercially launch Pro2cool in the U.S. in the first quarter of 2023.
Xeltis BV plans to expedite an international pivotal trial investigating its restorative hemodialysis access graft Axess following encouraging preliminary data. The company released results from a clinical trial investigating the graft at CX 2022, the Charing Cross International Symposium on Vascular and Endovascular Challenges, in London. Data showed the graft had 100% functional patency and safety in a patient cohort of 11, with a median follow-up of 6.5 months.
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
Xbiome Inc. acquired M-201, a clinical-stage program from Assembly Biosciences Inc., to treat patients with mild to moderate ulcerative colitis as it looks to develop products to address the growing incidence of bowel disease throughout Asia. The company expects to start a phase Ib trial of the oral live biotherapeutic product in the U.S. in 2022 and also plans to run clinical trials in China.
In launching the European Health Data Space May 3, the European Commission (EC) heralded it as “a fundamental game-changer for the digital transformation of health care in the EU.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosensors International, Isono Health, Mirvie, Spinex, Strados, Suneva Medical, X-Therma.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908 Devices, Biotium, Cerus, Cognitivecare, Cue, Fresenius Kabi, Ion Beam Applications, Modus Medical Devices, MTF Biologics, Orthofix Medical.
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