How has the FDA addressed these criticisms and concerns over time?

Jan 21, 2022 ... The BioFire COVID-19 Test 2 is an in vitro diagnostic test used in conjunction with the BioFire FilmArray instrument to analyze nasopharyngeal swab, or NPS, ... Feb 8, 2024 ... For comparison, the FDA mean review times were 150 days for 510(k)s ... And the 510(k) clearance pathway is generally easier and faster. Nov 20, 2024 ... “THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with ... 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. 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 ... Apr 2, 2024 ... "Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, ... 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 ... Aug 22, 2024 ... A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a ... 8 days ago ... Laser endoscopy ophthalmic system receives FDA 510(k) clearance · Study: Home OCT impacts physician decision making · FDA does ... The mean IOP ... May 6, 2021 ... What is the risk of recall and high-risk recall for devices undergoing US Food and Drug Administration (FDA) 510(k) clearance compared with ...