The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIST ramps up Zero Trust cybersecurity program; TGA sets date for mesh up-classification; IMDRF posts post-market study update; ANVISA updates list of non-regulated devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Enterprise, Ezra, Spectrum Solutions.
The news that the U.S. FDA has opened a new digital health office carries some significant expectations for stakeholders, expectations that may take time to meet. More than one participant in the Oct. 19 FDA listening session for the Digital Health Center of Excellence (DHCoE) called on the FDA to ensure that this new center provides more regulatory clarity regarding a number of products, a task that may be some time in coming, given the need to harmonize with other national and international regulatory entities.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA’s cybersecurity discussion paper emerges; CMS eyes MAC default for Allomap coverage; CMS floats draft coverage for CRC screening test.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosensors International, Centogene, DNA Genotek, Dxterity, Everlywell, Fresenius Medical Care, Ossio, Thermo Fisher Scientific.
Endologix LLC has begun a controlled launch of its Alto abdominal stent graft in Europe, following the receipt of CE mark approval in August. The next-generation Ovation system for polymer endovascular aneurysm repair (EVAR) is designed to provide the broadest indications in infrarenal EVAR grafts, including a 7 mm aortic neck length indication.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Genalyte.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts guidance agenda for FY 2021; Third-party 510(k) review report posted; NIOSH testing flunks more imported filter masks; OIG says Cedars-Sinai billed for non-compliant bariatric surgeries.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Livmor, Sanuwave, See-Mode Technologies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.
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