A panel at the J.P. Morgan Healthcare Conference touched on how multiple remote patient monitoring devices and management can be streamlined via machine learning to identify patients who need follow up, in many cases in their homes, increasing value without increasing the burden on already short-staffed health care organizations. The panelists saw technology as a way around a shortage of providers that could both increase access to care and deliver more targeted acute care while also addressing factors in health disparity to prevent development of disease. Read More
Some patent litigation cases don’t require a deep effort to interpret claims, but the litigation between Agilent Technologies Inc., and Dionex Softron GmbH, forced the Court of Appeals for the Federal Circuit to determine whether a written description adequately captures the use of a piston in a liquid chromatograph to avoid nullification of the claim. Read More
The U.S. FDA has granted Opticyte Inc. a breakthrough device designation for its Cell O2 patient monitor, a noninvasive technology for monitoring patients at risk of organ failure. The device could help to reduce serious illness and deaths by alerting clinicians to patients experiencing organ failure before irreversible damage occurs. Read More
Cardiovascular Systems Inc. (CSI) reported the submission by its partner Innova Vascular Inc. of U.S. FDA premarket notification for thrombectomy devices to treat peripheral vascular disease. Already an acknowledge leader in atherectomy technologies, St. Paul, Minn.-based CSI intends to acquire and commercialize each device to expand its technology portfolio to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Read More
U.S. FDA warning letters for medical devices are relatively rare these days, and the Oct. 6, 2022, warning to Empowered Diagnostics LLC of Pompano Beach, Fla., suggests that COVID tests are still front and center where FDA enforcement is concerned. Read More
New hires and promotions in the med-tech industry, including: Aptamer Group, Aspen Surgical, Healthy.io, Microtransponder, Nyxoah, Quanterix, Sengenics, Sysmex America, Vizgen, Vygon Group. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Diadem, Geneoscopy, Neuroptics, Synchron. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biointellisense, Brainsway, Care.ai, Catheter Precision, Cerveau, Coeus, Dermtech, Foundation Medicine, Fusion Genomics, GE Healthcare, Imactis, Karyopharm, Neuronetics, Organox, Othair, Pear Therapeutics, Prothena, Prothena, Ra Medical Systems, Sophia Genetics, Theranica, Thirona. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Act Genomics, Arthrex, Bactiguard, Cellmyx, Inogen, Medalliance, Micronoma. Read More
