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. OWH has funded research projects that address health issues affecting women across their lifespan. Read the full article here.
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.