How does the FDA communicate information about the safety and effectiveness of medical devices to the public?

Mar 9, 2022 ... Information that supported 510(k) cleared assays is publicly available! ... What does this mean? • Intended only for Employment and ... Feb 14, 2025 ... The goal of the 510(k) submission is to demonstrate that the device is "substantially equivalent" to a device that has already been cleared by ... Jan 30, 2025 ... In addition to the clearance, AI Optics is ... A total of 196 patients (48.5% women; mean age, 61 years) were identified who had been referred for ... 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 ... Mar 17, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram ... 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 ... TPRG specializes in the review of 510(k) submissions, providing you with efficient FDA clearance. The Third Party Review Group is the expert in 510K TPR ... Apr 16, 2017 ... FDA's analysis of whether to exempt a type of device from the 510(k) requirements is specific to the devices within the generic category in ... FDA has a clear definition of the 510(k) pathway which allows manufacturers ... FDA's Premarket Approval (PMA) pathway. The European Union CE marking ... Nov 22, 2024 ... The US Food and Drug Administration (FDA) 510(k) clearance of remote scanning and remote protocol adjustment features on Philips Radiology Operations Command ...