Children with autism spectrum disorder (ASD) can face a lifetime of frustration because of challenges with communication, social behaviors and flexibility of thought. Early intervention can improve outcomes, but nailing a diagnosis of ASD often takes years. Cognoa Inc. wants to change that with its digital ASD Diagnostic and is on track to apply for U.S. FDA clearance before the end of the year. Read More
Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee. Read More
HONG KONG – Seoul, South Korea-based Vuno Inc. reported that it plans to list on South Korea’s Kosdaq bourse either by the end of 2020 or early next year, CTO and cofounder Kyu-hwan Jung told the 2020 Bioplus Interphex Korea Conference. After receiving A ratings in the recent technology evaluations by assessment institutions NICE D&B and Korea Enterprise Data, Vuno submitted a preliminary examination application to the bourse on July 28 that is currently underway, the company said. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) has posted a proposed rule for coverage of FDA-designated breakthrough devices, a programmatic objective that has been front and center for the agency for several years. However, Tamara Syrek Jensen, director of the Coverage and Analysis Group (CAG) at CMS, said the proposal to redefine the term “reasonable and necessary” may be the more critical piece of the proposed rule because it would give the agency unprecedented flexibility in covering a broad swath of medical technologies. Read More
Two studies seek to answer the most pressing question for physicians examining a patient with COVID-19: What's this person's risk of death? Mount Sinai researchers presented their clinical prediction model in The Lancet Digital Health and a team from Johns Hopkins published their risk calculator in the Annals of Internal Medicine. Read More
The U.S. FDA has granted breakthrough device designation status to Medtronic plc’s Tyrx absorbable antibacterial driveline wrap, a medical device aimed at reducing driveline complications in patients receiving a ventricular assist device (VAD). Read More
New hires and promotions in the med-tech industry, including: Creavo Medical, Mercury Medical, Nano-X, Onsight Medical, Pressao Medical, Spinal Elements, Strive Health. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bio Conscious, Bio-Techne, Immunexpress, Kubtec. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accenture, Angle, Ardigen, Bioclinica, Caresafely, Change Healthcare, Cpsi, Ebamed, GI Reviewers, Longitude Capital, Medtronic, Quadvantage Technologies, Royal Philips, Thermo Fisher Scientific, Think Surgical, Total Joint Orthopedics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capsovision, Orbusneich, Surmodics, Urotronic. Read More
Keeping you up to date on recent developments in orthopedics, including: Technology for printing customized neuroprostheses on a 3D bioprinter; AI could expand healing with bioscaffolds; AI detects osteoarthritis years before it develops; 'Bandage' developed to rebuild broken bone. Read More
