There is “a wide gap” in the availability of pediatric medical devices that suggest most of these were developed for adolescents, according to a new study on FDA premarket approval applications (PMAs). The findings stem from an evaluation of 297 PMA documents for 149 high-risk devices, 68% of which include pediatric age indications. Pediatric medical devices have lagged behind their adult counterparts in terms of availability, options and innovation. The new findings add to the current relatively limited body of research considering the ample medical device space but are consistent with previous findings that most devices indicated for children are limited to those over 18 years of age. Read More
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. Read More
Adela snapped up $60 million in a series A financing round to commercialize its blood test for cancer detection and disease monitoring. At the same time, the company announced its name change from Dnamx Inc. The Adela system profiles all methylated DNA fragments in a blood sample, allowing it to determine the tissue of origin early in development of a malignancy and potentially simplifying screening across all cancer types. Read More
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. Read More
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. Read More
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. Read More
Med-tech firms raising money in public or private financings, including: Alayacare, Codex DNA, Epipole, Figur8, Second Sight Medical Products, Silk Road Medical. Read More
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. Read More
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. Read More
