Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Thermo Fisher.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dixi Medical, Estar, Hologic, Medx, Minerva, Motus GI, Natera, Neuropace, Rapid, Parkway Medical, Wetrade.
Surgical mesh product liability litigation has fed a massive volume of billable hours for attorneys on both sides of these lawsuits, but a recent case went the way of Coloplast AS unit Coloplast Corp., of Minneapolis, which prevailed over a litigant in a case heard in a Minnesota district court. Despite the win, the case sustains an ongoing debate over whether the gatekeeping function for expert testimony was appropriately exercised, an issue that may soon be clarified by an advisory body on judicial procedures.
Implementation of the new regulations for medical devices and in vitro diagnostics in the EU have presented a number of problems, including a serious crunch in the availability of notified bodies (NBs) to review premarket filings.
Viome Life Sciences Inc. launched its Cancerdetect test for oral and throat cancer, the first in a developing portfolio of tests that use mRNA technology and an artificial intelligence (AI)-driven platform. The saliva-based oral and throat cancer test demonstrated 95% specificity and 90% sensitivity in identifying these notoriously difficult to diagnose malignancies in a recent study.
Investors are backing Levita Magnetics International Corp. with $26 million to advance its new Magnetic-Assisted Robotic Surgery (MARS) platform. The series C financing round was led by Ballast Capital, with participation from Medtex Ventures, Invermaster and Carao Ventures. The new platform builds on the company’s first commercial device, the Levita Magnetic Surgical system which received U.S. FDA approval in 2015. The system enables reduced-port laparoscopic surgical procedures and consists of an external magnet that is placed on the skin and controls a magnetic grasper inside the abdomen during surgery.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Immunovia, Roche.
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