Digital therapeutics startup Akili Interactive Inc. has secured $160 million in a combined equity and debt financing to accelerate commercialization of its Endeavorrx platform for cognitive disorders. The company won FDA clearance and the CE mark in June 2020 for its video game-based treatment, Endeavorrx ALK-T01, for children with attention deficit hyperactivity disorder (ADHD).
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beyond Air, Circassia Group, Exthera Medical, Gensight Biologics, Henry Schein, Innova Medical Group, Medical Diagnostic Laboratories, Mesi, Mirati Therapeutics, Neovasc, Qiagen, Sharp Packaging, Retractable Technologies, Udg Healthcare.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bimini Health Tech, Ibex, Koya Medical, One Drop, Pentax Medical, Turner Imaging Systems, Varian, Visionairy Health, Xandar Kardian.
Med-tech firms raising money in public or private financings, including: Dynamics, Hello Heart, Intocare Medical Technology, Sonnest, Torus Biosystems.
For the next three years, the government of Shanghai will hand out R&D subsidies up to ¥100 million ($15.6 million) per year to each biopharma company in the municipality to support innovative medicines. Med-tech players can also each receive up to ¥15 million a year for developing innovative devices.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Foldax, Geneoscopy, Noctrix Health, One Medical, Procyrion.
With a number of Medicare coverage policies in flux, the U.S. Senate has confirmed Chiquita Brooks-LaSure as the next CMS administrator, closing out one more critical remaining position for the Biden administration at the Department of Health and Human Services. Still unannounced is the administration’s nominee to lead the FDA, an omission that becomes more conspicuous with each passing day.
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