It’s a little early for St. Patrick’s Day, but the green is surely flowing for Acutus Medical Inc. as the company achieved its second milestone under the terms of its asset purchase agreement with Medtronic plc and triggered a $17 million payment. Read More
With yet another deadline looming for passage of spending bills for the U.S. federal budget, Congress has drafted an omnibus spending bill that would extend coverage of Medicare telehealth services. The problem with the legislation in the eyes of many stakeholders is that the Verifying Accurate Leading-edge IVCT Development (VALID) Act is not part of the package that must be passed by Dec. 23, an omission that leaves lab-developed tests (LDTs) in a nether world of regulatory ambiguity. Read More
Women’s health startup May Health SAS has completed treatment of the first five participants in a U.S. feasibility study of its investigational Ovarian Rebalancing technique, a one-time, ultrasound-guided, transvaginal ablation procedure for women with polycystic ovary syndrome (PCOS). The novel treatment is designed to jumpstart the ovaries into releasing mature eggs in normal monthly cycles in women with PCOS-associated infertility. Read More
Seven new U.S. medtechs are poised to make a splash in the diagnosis and treatment of nervous system disorders thanks to funding under a new program within the National Institutes of Health (NIH) Blueprint for Neuroscience Research called Blueprint Medtech. Read More
Repeat expansions of two or more base pairs cause dozens of neurological disorders – Huntington’s disease, which is caused by an expansion of the triplet CAG in the coding sequence for huntingtin, is perhaps the most famous one. Now, investigators at Stanford University have shown that cancer genomes, too, frequently feature repeat expansions. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Foundation Medicine, Venus Concept. Read More
