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.
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.
The COVID-19 pandemic has been more than just a distraction for the U.S. FDA, which started 2020 with a number of ambitions regarding digital health regulation. Despite having unveiled the Digital Health Center of Excellence to great fanfare, the agency is struggling to wrap up major digital health programs, such as the precertification program for software as a medical device, leaving the FDA with a daunting agenda for digital health in the coming year.
The rising tide of digital therapeutics approved and funded in the U.S. raised the outlook for Mahana Therapeutics Inc. and Freespira Inc. as both companies announced good news. Mahana's prescription digital therapeutic for gastrointestinal conditions, Parallel, received premarket authorization from the U.S. FDA and Freespira, formerly Palo Alto Health Sciences Inc., raised $10 million for its digital therapeutic for panic attacks, panic disorder and post-traumatic stress disorder.
HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and new devices are developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8.
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).
TORONTO – Ontario and British Columbia med-tech companies have received CA$1.4 million (US$1 million) from Ottawa’s Supercluster fund, making a difference they said for patients suffering the long-range effects of COVID-19, chronic disease and undergoing joint replacement surgery.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mahana Therapeutics, Nanovibronix, Paige.AI, Solvd Health, Zebra Medical Vision.
While telehealth has been gaining traction over the last few years, the COVID-19 pandemic really shined a spotlight on this rapidly rising space. In July, Globaldata predicted that the telehealth industry likely would reach $20 billion by 2024, boosted by a loosening of restrictions. Indeed, an Oct. 30 CDC report highlighted a 154% increase in telehealth visits during the last week of March vs. the same period in 2019. The authors added that policy changes could help boost access to care via telehealth during and after the pandemic.