Stryker Corp. continued its aggressive M&A program this year with the planned acquisition of Vertos Medical Inc. Vertos offers a minimally invasive lumbar decompression (Mild) solution for chronic lower back pain caused by lumbar spinal stenosis. The announcement brings Stryker to six deals so far this year: Société d'Etudes, de Recherches et de Fabrication (SERF) SAS, Mfphd LLC, Artelon Inc., Molli Surgical Inc., Care.ai Inc. and now Vertos. Financial terms were not disclosed for any of the transactions.
The U.S. FDA’s draft guidance for predetermined change control protocols for all device types fills in a gap left by previous draft guidance, but there is one potential stopping point for class III devices.
A new brain-computer interface (BCI) developed at UC Davis Health is able to translate brain signals into speech with up to 97% accuracy – the most accurate system of its kind.
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
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