How does the FDA approach the review of non-inferiority and superiority clinical trials for medical devices?

FDA Cleared: When used correctly, this term refers to FDA allowing a device to market through the 510(k) process based on substantial equivalence to a legally ... Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... Aug 22, 2022 ... The step means that Nerve Tape's development partner, Atlanta ... Nerve Tape is the company's first FDA-cleared medical device and ... 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 ... Apr 2, 2024 ... "Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, ... Jan 17, 2023 ... Henry further said it's important to keep in mind that the definition of “recall” is broad and doesn't necessarily mean a product was so ... Feb 7, 2024 ... One crucial milestone for many health apps is obtaining 510(k) clearance from the US Food and Drug Administration (FDA). But what exactly does ... May 21, 2017 ... Soterix Medical is the world leader in non-invasive neuromodulation and brain stimulation technology. Researchers and clinicians choose ... Feb 4, 2025 ... FDA clearance through the 510(k) process means the agency agrees ... What does it mean to be 510(k) exempt? Some medical devices are ... Jun 5, 2024 ... A legally marketed predicate means the device has previously gone through a 510(k) clearance process and obtained FDA clearance or was on the ...