Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ultrasight.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AI Medical Service, Claripi, Concertai, GC Genome, Invo Bioscience, Neogenomics, Novarad, Teleflex, Terarecon, Vielight.
Beijing Tinavi Medical Technologies Co. Ltd.’s surgical robot received approval from China’s National Medical Products Administration (NMPA) for total knee replacement, expanding its product portfolio to cover spine, trauma and joints in orthopedic surgery. The new product, named Tirobot Recon, provides support for surgeons in total knee arthroplasty.
Deep learning algorithms are used to remotely monitor and track just about everything these days and now that includes ordinary and chronic cough. Hyfe Inc. has launched an AI-driven remote patient monitoring (RPM) program designed to monitor cough for a whole range of serious ailments at virtual hospitals, remote care and telehealth programs across the U.S.
The U.S. FDA has issued a draft guidance for devices intended to address opioid use disorder (OUD), a problem with a massive public health footprint that has defied the efforts of public health programs. The draft guidance highlights some of the difficulties in executing pivotal studies for these devices, but the FDA’s July 27 press omits any mention of a 2018 innovation challenge for this category of devices, a programmatic effort that seems to have yielded little in the way of tangible results.
News from Truvian Health Inc. that its benchtop blood testing platform can deliver results similar to those generated by central laboratory is promising for the diagnostic sector still coming to terms with fraudulent claims from companies such as Theranos Inc. and Arrayit Corp. that their various technologies were able to run an array of tests with just a few drops of blood.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Hope Vision, Numares.
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