The FDA’s device center recently updated its guidance for testing and labeling of devices for compatibility with magnetic resonance (MR) fields. Some items, such as orthopedic plates and screws, might not have been evaluated for compatibility up to now. The FDA’s Sunder Rajan said that existing 510(k) and PMA devices are grandfathered in under the legacy policy, but that all implants will have to be evaluated for MRI compatibility going forward, even devices not previously subject to testing.
TORONTO – Health Canada has proposed a single regulatory framework for medical device and drug clinical trials after broad industry consultation and a hard line drawn by the COVID-19 pandemic for a more streamlined system.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diabetomics, Oticon Medical, Otolith Labs, Sorrento Therapeutics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biomerica, Canon Medical Systems, Cmic, Cutiss, Draper, Haven Testing, Immudex, Invivoscribe, Johnson & Johnson, Lokavant, Medtronic, Merck, Novarad, Nucleai, Omron Healthcare, Penumbra, Rapid AI, Surfacide, United Therapeutics.
New hires and promotions in the med-tech industry, including: Artio Medical, Femasys, Motus GI, Neurent Medical, Piccolo Medical, Smisson-Cartledge Biomedical.
LONDON – New data from a randomized community study involving more than half a million people has shown that of 92,116 who had symptomatic COVID-19, 38% were still reporting symptoms 12 weeks later.
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.
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.
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