We are hyper-focused on continuing to deliver on our vision of ‘saving a life’. We are strategically growing and working to embed our technology in clinical workflows at forward thinking…
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OWH-Funded Research: Medical Device Safety The FDA Office of Women’s Health awards research grants for 1-2 year studies to support FDA regulatory decision-making and advance the science of women’s health….
FDA has recently approved the following devices to be marketed: PulseRider Aneurysm Neck Reconstruction Device (“PulseRider”) – H160002 The PulseRider is a permanent nitinol (nickel titanium) self-expanding stent implant for…
A thanks to @US_FDA for linking to our website and App download. We’re a part of the #OpenFDA Developer Community. https://buff.ly/2FGVeEq Check it out! #medicaldevice #surgery #medical #FDA
Excellent Read Here! FDA Commissioner Scott Gottlieb, M.D., commits to improving the FDA regulated recall process. The current push and ongoing focus of improving this process only further supports our…