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Helsinki, Finland-based Bioretec’s bioresorbable Activa IM-Nail was effective in treating pediatric forearm fractures in an ongoing postmarket study by European researchers. Read More
Novela Neurotechnologies, a digital health company that specializes in epilepsy care, has acquired a portfolio of seizure-monitoring devices through the purchase of Brain Sentinel’s intellectual property, including 58 patents and applications. Read More
GE Healthcare and Medtronic have gained FDA 510(k) clearance and the EU CE mark for an integration of two Medtronic technologies with GE Healthcare's CARESCAPE monitors that will allow physicians to continuously monitor patients at the bedside and in transport as well as automatically transmit data to their electronic medical records. Read More
Two lines of Becton Dickinson (BD) devices that rely on software can be hacked relatively easily, the U.S. Cybersecurity and Infrastructure Security Agency said, deeming both to be vulnerable to “low-attack complexity.” Read More
Orthofix Medical’s M6-C artificial cervical disc showed significant benefit over spinal fusion in data from a five-year clinical trial conducted under and FDA Investigational Device Exemption (IDE). Read More
San Diego, Calif.-based Quidel has completed its $6 billion acquisition of Ortho Clinical Diagnostics, creating what the newly merged company, QuidelOrtho, calls a “balanced and diversified” portfolio of diagnostic instruments and assays. Read More
If part of your cleaning procedure is swab samples, FDA investigators will expect to see how the swab sample is taken. Is it vertical? Is it horizontal? How large of an area is swabbed? Where is the swab taken? Read More