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 the treatment of wide-necked aneurysms located at or near branching areas of arteries in the brain. The device’s Y or T shape provides support 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
This technology could help clinicians to diagnose and monitor #neurological conditions such as #epilepsy. In the future it may be useful for brain-machine interfaces, such as those controlling #prosthetic limbs. Soft Electronics for Long Term Neural Monitoring and Recording
Know about your medical device implant. Here is the recall class breakdown. An FDA “Class I Recall” is the most urgent type of recall that the FDA will issue. In an FDA Class I Recall, there is significant and immediate danger of death or other serious injury from the use of the product being recalled….
Breasts implants with unexplainable symptoms Facing unexplainable symptoms, Kansas City Metro Women argue silicone breast implants made them sick. Read the full story here.
Is the medical device industry moving too fast to keep patients safe? Are much needed clinical tests being skipped? Check out this article by Jeanne Lenzer. #medicaldevice #physicaltherapy Take action and be informed about your health! Start tracking your medical device implant(s) now with our TrackMy™ Implants App.
Do you or someone you know have a medical device implant? Do you love FREE COFFEE? Only two simple steps to be entered for a chance to win. 1.) Download our TrackMy™ Implants App 2.) Post an App screenshot on our Facebook page. The winner will be announced 3/10/18. Download the App here! (App Store…
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 mission of engaging and educating patients to better manage their health!
UDI stands for Unique Device Identifier. Barcodes aren’t just for the department stores anymore. UDI is becoming a standard topic among healthcare providers. Check out this article by Karen Conway, Executive Director, Industry Relations, GHX
Compliance Dates for UDI Requirements The table below outlines key compliance dates in the UDI final rule. Compliance Date Requirement 1 year after publication of the final rule (September 24, 2014) The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI….