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.
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.
Airehealth Inc.'s management took a deep breath on hearing that the company's Vitalmed nebulizer received U.S. FDA 510(k) clearance after waiting nearly 11 months. The portable, electronic, vibrating mesh nebulizer will connect to the Orlando, Fla.-based company's diary companion app early next year as part of an integrated suite of products designed to help individuals with chronic respiratory issues track symptoms and better manage their care.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA issues guidance on enforcement policy regarding certain quality standards requirements under MQSA; MHRA looks to provide additional help post-Brexit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaite, Airehealth, Rheonix.
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