Michael Mina, assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, again criticized the U.S. FDA for taking a conventional regulatory approach to rapid antigen tests for the pandemic. However, not everyone at the FDA’s parent department deserves brickbats. Mina said Assistant Secretary for Health Brett Giroir deserves a lot of credit for assisting in the effort to stand up pilot studies for rapid antigen tests that could be used to restore the U.S. economy even in the absence of a fully rolled-out vaccination campaign. Read More
Edwards Lifesciences Corp. held its 2020 virtual investor conference Dec. 10, providing details on its 2021 financial outlook. The company is projecting global mid-teen sales growth totaling $4.9 billion to $5.3 billion and a return to double-digit sales growth in its transcatheter aortic valve replacement (TAVR) business. Earnings per share (EPS) guidance for the coming year is $2-2.20, below the consensus estimate of $2.21, due to investments in R&D and sales to fuel future growth. Read More
Advanced Bionics LLC heard good news from the U.S. FDA, which granted approval for the company’s Marvel cochlear implant (CI) platform and the first-ever sound processor designed specifically for children. The development brings the Marvel platform, initially created for hearing aids produced by Advanced Bionics' sister company, Phonak AG, to the sound processor for CIs for the first time. Read More
TORONTO – Waterloo, Ontario-based DarwinAI Corp. and Raleigh, N.C.-based Red Hat Inc.are developing a suite of deep neural networks for COVID-19 detection and risk stratification via chest radiography in cooperation with Boston Children’s Hospital. DarwinAI designed COVID-Net as “explainable” artificial intelligence (AI) that illuminates the inner workings of AI-driven medical technologies and promptly offered it on an open-source platform for the broader hospital community. Read More
PERTH, Australia – Med-tech company Control Bionics began trading on the Australian Securities Exchange (ASX:CBL) Dec. 7 in an IPO that saw the company raise AU$15 million (US$11.25 million). Melbourne-headquartered Control Bionics develops assistive technologies (AT) that allow people with severe disabilities to communicate and control electronic devices using electromyography (EMG). Read More
LONDON – A study of genetic variants in patients with life-threatening COVID-19 has shed light on the mechanisms that underpin severe disease, uncovered new drug targets and pointed to approved drugs, including JAK inhibitors and phosphodiesterase type 4 inhibitors, as therapies that could aid recovery. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA delays comment period for electromagnetic compatibility draft; CMS, ONC post info sharing, prior authorization rule; Van Hollen debuts diagnostic accuracy bill; CDC updates POC testing guidelines; GAO: Specimen biopsy handling errors relatively low. Read More
Med-tech firms raising money in public or private financings, including: Abcellera Biologics, American Bio Medica, Certara, Nanobiotix, Neovasc, Vivos Therapeutics. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agendia, Caris, Creatv Microtech, Diadem, Exact Sciences, Myriad. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akoya Biosciences, Biocogniv, Dermtech, Djo, Litecure, Nanalysis, Nanovibronix, Neovasc, Pear Therapeutics, Roche, Rs2d, Spinal Elements, Ultra Pain Products. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode. Read More
Keeping you up to date on recent developments in neurology, including: Genetic differences important in Alzheimer’s diagnosis; Stanford develops tool for studying neural activity; Gut microbiota plays a role in brain function, mood regulation. Read More
