Angle plc, of Guilford, U.K., said it has completed a de novo submission for its Parsortix Pc1 seeking U.S. FDA clearance for use with metastatic breast cancer patients. The submission has also been designed to meet CE mark requirements and, if granted FDA clearance, the company plans to register for CE mark approval, allowing clinical sales in both the U.S. and Europe.
Palo Alto, Calif.-based Endpoint Health Inc. is partnering with Vanderbilt University Medical Center to create the first precision medicine clinical trial network focused on late-stage clinical trials in critical illness. The network will bring together leading critical illness researchers, trialists and medical centers from across the U.S. to support phase II and III interventional trials, prioritizing precision-driven interventions to treat problems such as sepsis and acute respiratory distress syndrome.
Houston-based regenerative medicine company Fibrogenesis has entered a manufacturing agreement with Ibiologics LLC, of Salt Lake City, to supply its allogeneic fibroblast cells to support Fibrogenesis’s growing chronic disease platform and ongoing clinical trials.
Voice-enabled virtual health assistant company Handsfree Health, of Wayne, Pa., has released a wearable medical alert system that integrates 24/7 emergency monitoring with its Wellbe voice assistant for consumers.
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Kalamazoo, Mich.-based Stryker Corp. reported the launch of its T2 Icf Intramedullary nailing system, offering a solution for patients suffering from serious foot conditions such as Charcot foot, a condition associated with diabetes.
Source: Bioworld