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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aferetica, Cytosorbents, New World Medical.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA taking adcomm nominations; HHS, DoD ink deal with Cue Health; NTAP town hall set for Dec. 15-16.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cefaly Technology, Crossbay Medical, Fh Ortho, Immersivetouch, Micro Medical Solutions, Sonivie.
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