A percutaneous hydrogel treatment for chronic low back pain has won a U.S. FDA breakthrough device designation. The status will enhance interactions between Baltimore, Md.-based Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization.
Calling it a “a critical milestone in its fight against COVID-19,” Health Canada authorized the Pfizer Inc./Biontech SE COVID-19 vaccine for people age 16 or older.
NEW DELHI – Recent changes to India’s rules on medical devices have evoked mixed reaction among industry and legal experts with concerns over their impact on patenting of innovations tinged with a welcome reception of a new clause for mandatory registration and licensing of medical devices in the country to improve adherence to quality requirements.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medical Ingenuities, Mesa Biotech, Regeltec, Sonivie, Volta Medical.
The latest global regulatory news, changes and updates affecting biopharma, including: Sacklers threatened with House subpoena; DEA proposes de-scheduling Alkermes drug; Marburg MCMs protected under PREP; OPDP: Don’t make risks a P.S.; U.S. Senators sound off on E&M offsets.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Albireo, Amryt, Bebig, Beigene, Citius, Chugai, Lipocine, Pfizer, Rafarma, Sinovac, Sorrento, Tricida, Tvax, United, Valeo.
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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Metal-containing masks can cause injuries during MRIs.
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.
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