Are there any mechanisms for independent review of FDA decisions on medical devices?

Nov 29, 2023 ... With this unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of OSA severity. Jan 29, 2025 ... 2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on ... Jan 4, 2023 ... • it is marketed without a 510(k) clearance (when applicable);. • a restricted device uses false or misleading advertising or is sold ... Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of ... Aug 4, 2022 ... “When Xoran states that TRON is the 'One RING to rule them all,' we truly mean that this compact, mobile, open-bore device is poised to ... Sep 19, 2023 ... The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat ... ... 510(k) Timeline. FAQs. What does 510(k) stand for? 510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act. * Source: https://www.fda.gov ... Jan 7, 2025 ... This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can ... Mar 17, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram ...