How can manufacturers utilize post-market data to identify and address potential safety issues with their devices?

Nov 13, 2024 ... It includes the latest features used in molecular imaging and simplifies workflows significantly. This is a new milestone in NM Processing and ... 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. FDA clearance through the 510(k) process means the agency is in agreement with the manufacturer that a medical device is similar to a previously approved ... Mar 22, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, “This FDA 510(k) clearance is a defining moment for Monogram ... Technically, the FDA does not “approve” medical devices or IVDs for sale under the FDA 510(k) premarket notification process. The FDA gives “clearance” for them ... ... 510(k) process; the agency gives the nod for them to be marketed in the U.S. Please note that FDA approval and FDA clearance mean the same. Premarket ... 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 ... 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 ... 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 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 ...