What are the considerations for the biocompatibility testing of medical devices?

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 ... Oct 1, 2024 ... ... (FDA) for its PlaqueIQ™ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). PlaqueIQ is the first FDA-cleared ... Jan 30, 2023 ... ... dose concerns mean CT is not optimal. Adaptix's central mission is to transform radiology by offering affordable low-dose 3D imaging at the ... Dec 10, 2019 ... The InSet™ Total Shoulder System is used to treat significant disability in degenerative, rheumatoid, and traumatic disease of the glenohumeral ... 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 ... Mar 14, 2024 ... The US Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company's next-generation multiport robotic system. Feb 8, 2024 ... For comparison, the FDA mean review times were 150 days for 510(k)s ... And the 510(k) clearance pathway is generally easier and faster. Jul 29, 2024 ... The FDA's action means that SPIRA-A Integrated is now indicated for use at one or more levels, from L1-S1 as an adjunct to fusion in skeletally ... Physiomesh for market pursuant to its 510(k) process, which means that the FDA ... the Court finds that any probative value of the FDA 510(k) clearance is ... 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 ...