How does post-market surveillance data inform the FDA's ongoing assessment of the 510(k) program?

Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ... 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, ... Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... 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 ... 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. 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 ... Oct 4, 2023 ... Anumana's ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to screen for LEF in adults at risk for heart failure. It is important to seek feedback from FDA at a time when it will be of most value. o Initiating a pre-submission meeting early might mean that you still have ... Sep 6, 2023 ... A Premarket Notification [510(k)], when the device is low to moderate risk and there is a legally marketed predicate device. Regardless of the ... Jan 12, 2024 ... The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use ...