What are the safety considerations for devices used in rehabilitation?

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. Jul 21, 2016 ... The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least ... Leading letter “K” indicates 510(k) clearance, or Premarket Notification. This is an .exact field. It has been indexed both as its exact string content, and ... Deliver more personalised digital-first care and research with our enterprise platform which now has FDA 510 (K) Class II clearance for any physician-specified ... Mar 7, 2022 ... Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug ... 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 ... Sep 29, 2023 ... Many Software as a Medical Device and AI developers are looking to the US for a cheaper and speedier regulatory approval via an FDA 510(k) ... Following is a breakdown of 510(k) exempt and Good Manufacturing Practice ... FDA is taking this action in order to meet requirements of FDAMA and the ... Jan 3, 2024 ... May is an incredibly variable month for FDA decision-making and I don't honestly know why. Variability means that there's a lack of consistency, ... FDA 510(k) Medical Device Clearance. The 510(k) pathway is based on ... A claim of substantial equivalence does not mean the device(s) must be identical.