302018Mar
Office of Women’s Health

Office of Women’s Health

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.

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132018Mar
FDA recently approved devices

FDA recently approved devices

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…

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62018Mar
Medical Device Recall Class Type

Medical Device Recall Class Type

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….

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12018Mar
Can Your Hip Replacement Kill You?

Can Your Hip Replacement Kill You?

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.

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