Activ Surgical Inc. has closed a $45 million series B financing round to kick off commercialization activities of its augmented reality surgical software suite. Founded in 2017, Boston-based Activ Surgical is preparing to commercialize its first product Activinsights, an FDA-cleared software that provides real-time, intraoperative visual data such as key blood flow identifiers to surgeons. Read More
Jury trials for product liability litigation are not always the last stop for these lawsuits, but courts are more frequently banning device makers from presenting evidence related to premarket filings in these proceedings. One example of this was the pelvic mesh trial of McGinnis v. Bard, in which the trial judge allowed the plaintiff to make nearly two dozen references to the FDA without allowing rebuttal from counsel for the defense, thus biasing a jury that awarded the plaintiff $68 million without hearing the entirety of the evidence. Read More
Medtronic plc strengthened its suite of products for minimally invasive spine surgery with several new additions. The portfolio provides an integrated solution that includes implants, navigation, robotics, and artificial intelligence to streamline transforaminal lumbar interbody fusion (TLIF), customize treatment for patients and improve outcomes. Read More
Shanghai Wision AI Co. Ltd. (Wision AI) has shared positive data from a first-of-its-kind study on the use of artificial intelligence (AI) computer-aided polyp detection (CADe) system during colorectal cancer screening in a U.S. patient population. Published in the journal Clinical Gastroenterology and Hepatology, it marks the world’s first external independent randomized controlled trial of AI in the medical field conducted in the U.S. Read More
As if it were needed, Amicus Therapeutics Inc.’s spin-off of its gene therapy work and PDUFA VII’s provisions to increase the capacity of the FDA’s Center for Biologics Evaluation and Research offered further proof this week of the global explosion that’s happening in the regenerative medicine field. Read More
LONDON – Industry-sponsored clinical research in the U.K. took a big hit in the pandemic and is still struggling to catch up – and to capitalize on innovative trial designs and delivery approaches that were so successful in speeding up COVID-19 studies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: ANP Technologies, Cardiovascular Systems, Cigalah Group, GE Healthcare, Illumina, Medow, Novacyt, Picard Medical, Syncardia Systems, Ultrasight. Read More
