What are the specific safety considerations for devices interacting with the nervous system?

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 1, 2011 ... 1) The 510(k) clearance process generally is not intended to evaluate the safety and effectiveness of medical devices because the standard for ... Jun 14, 2021 ... ... 510(k) process is focused on equivalence, not safety.'"10. The Court was critical of the amount of time and resources the FDA spends on 510(k) ... Mar 22, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, “This FDA 510(k) clearance is a defining moment for Monogram ... Dec 22, 2021 ... The FDA clearance is based on data from multiple studies of the ... mean tear film breakup time and meibomian gland secretion score ... 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) ... 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 ... 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 ... Jan 12, 2024 ... The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use ... 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, ...