Masimo Corp. selected Catherine (Katie) Szyman, an industry leader with deep med-tech roots, to guide the company as it seeks to rebuild its reputation and revenues following a gritty two-year battle for control. Current CEO Michelle Brennan will serve as chairman of the Masimo board. Brennan stepped up to lead Masimo after founder and former CEO Joe Kiani resigned following a shareholder vote that ousted him from his position of board chair as part of a protracted proxy battle between Kiani and Politan Capital Management LP. Read More
Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments waiver, will enable clinicians to detect several STIs including chlamydia, gonorrhea and Mycoplasma genitalium, in as little as 20 minutes. Read More
Ravgen Inc. prevailed in a hearing at the Federal Circuit over Labcorp Inc., seemingly bringing a close to a long-running dispute over patents for non-invasive prenatal tests. Ravgen has won damages that will likely exceed $400 million over alleged infringement of its patents for these tests, proof once again that a solid understanding of prior art is essential to avoid costly litigation. Read More
Standing for live visualization of brain circuits, LVIS Corp launched the cloud-based Neuromatch Access platform as a software as a service to help neurologists and medical professionals review, interpret and analyze electroencephalogram (EEG) data. Read More
Device makers know all too well the hazards of liability where their products are concerned, but those liabilities may soon balloon dramatically in the EU. Two pieces of EU legislation are in development, including the AI Liability Directive, which may have the effect of forcing the defendant in a liability case to prove that its product was not the cause of the alleged harm. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Exact Sciences, Helius Medical Technologies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biomimetic Innovations, Intuitive Surgical, Novocure, Orthopediatrics, Sanara Medtech, Thrive Orthopedics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inflammatix, Intelligenome, Roche. Read More
