Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asensus Surgical, Karl Storz, Neuraxis, Nexstim, Qiagen, Sinaptica Therapeutics, Stimvia.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Depuy Synthes, Mequ.
Germline variants that did not affect gene function nevertheless affected multiple aspects of breast cancer risk, via their visibility to the immune system and its reactions. Perhaps most surprisingly, the same genetic constellations that were protective at the very earliest stage of breast cancer, stage 0 or ductal carcinoma in situ, were associated with worse outcomes once a tumor had become invasive.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Enspectra Health, Seastar Medical, Venus Concept.
Researchers from the University of Chicago and Northwestern University have filed for protection of an mobile application to track individualized patient needs, engagement in continuous positive airway pressure machine use, and the correlation of risk behaviors to determine sleep apnea treatment progress.
Medical device manufacturers based in China may feel the FDA has a bullseye on their backs, but two firms located in Canada were the subjects of recently posted FDA warning letters.
In what undoubtedly came as a response to Medtronic plc’s recently reported Small Annuli Randomized to Evolut or SAPIEN Trial trial results that showed a decisive advantage for its Evolut transcatheter aortic valve replacement system in patients with a small aortic annulus, Edwards Lifesciences Corp. reported the results from an analysis of data from its Placement of Aortic Transcatheter Valve trials of the Sapien 3 valves showing “excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex.”