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The algorithm correctly detected tumors in 26 cores in the validation study that were originally reported as tumor negative, the company said. 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
In a clinical trial, the device successfully achieved fast, reliable biomechanical closure and rapidly stopped the flow of blood, the company said. Read More
The gentamicin-eluting ceramic bone void filler is intended for use in skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement. 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