How does 510(k) clearance impact a medical device company's marketing strategy?

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 ... Jan 21, 2022 ... The BioFire COVID-19 Test 2 is an in vitro diagnostic test used in conjunction with the BioFire FilmArray instrument to analyze nasopharyngeal swab, or NPS, ... Oct 21, 2021 ... The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance. 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 ... May 6, 2021 ... What is the risk of recall and high-risk recall for devices undergoing US Food and Drug Administration (FDA) 510(k) clearance compared with ... 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, ... 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 ... Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... May 21, 2017 ... Soterix Medical is the world leader in non-invasive neuromodulation and brain stimulation technology. Researchers and clinicians choose ... Oct 1, 2024 ... ... (FDA) for its PlaqueIQ™ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). PlaqueIQ is the first FDA-cleared ...