The follow-up to the U.S. 21st Century Cures Act, dubbed Cures 2.0, encodes several anticipated features such as a Medicare coverage mechanism for breakthrough devices and the Advanced Research Projects Agency for Health (ARPA-H). Less expected was a provision for the use of real-world evidence in evaluation of the safety and effectiveness of drugs and biologics after FDA approval, a provision that could prove useful in post-approval evaluations of products such as Biogen’s Aduhelm.
Quanta Dialysis Technologies Ltd. raised $245 million in a series D round led by Glenview Capital. The funds will be used to accelerate commercialization of the company’s SC+ portable hemodialysis system. Novo Holdings co-led the oversubscribed and upsized financing, with support from Blackrock, Eldridge, Sands Capital, Millennium Management, Monashee Investment Management LLC, Puhua Capital, Segulah Medical and Ancora, alongside Orlando Health, an integrated delivery network.
TORONTO – Femtherapeutics Inc. is combining artificial intelligence-driven machine learning and 3D design to manufacture a device for relieving urinary incontinence and discomfort in women suffering pelvic organ prolapse. The custom-made pessary is intended to support vaginal tissues displaced because of the condition, replacing conventional pessaries that company officials said can result in irritation and penetrate soft tissues causing bleeding.
LONDON – The U.K. is setting up a service for developers and users of artificial intelligence (AI) to provide a single source of advice covering all requirements for the technology, from clinical research to regulatory scrutiny, health technology evaluation and through to commissioning.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Cardiofocus, Flo Health, Hologic, Innova, Integrity Implants, New View Surgical, Penumbra.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Castor, Conformis, Dermtech, Electrocore, Establishment Labs, Hesperos, Intouch with Health, Kromax International, Lightship, Lmt Surgical, M2S, Moleculight, Namsa, Paramit, Prisma Health, Sherlock Biosciences, Siemens Healthineers, Somatus, Spinecraft, The Tecan Group, Vitalhub, Xr Medical Group, Wishbone Medical.
Med-tech firms raising money in public or private financings, including: Alayacare, Codex DNA, Epipole, Figur8, Second Sight Medical Products, Silk Road Medical.
Oncohost Ltd. has opened eight U.K. trial sites in the study assessing the ability of its artificial intelligence (AI)-driven proteomics profiling technology to single out which cancer patients will respond to treatment with immune checkpoint inhibitors. The sites will carry out proteomic analyses of blood samples from patients with late-stage melanoma or non-small-cell lung cancer (NSCLC), to predict their likely response to immunotherapy.
RSS
