Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avelas Biosciences, Foldax.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Activepure Technologies, Aditx Therapeutics, American Bio Medica, Ashvattha Therapeutics, Babylon Health, Builtspace, Diabeloop, Efemoral Medical, Eurofins Technologies, GE Healthcare, Hummingbird Bioscience, Insightec, Lifescan, Luminultra, Mymedbot, Novacyt, Novocure, Oncimmune, Pacific Biosciences, Roche, SonALAsense, Tempus Labs, Todos Medical, Variscite, Welldoc.
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).
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.
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.
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.
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.
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