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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262018Feb
Free Starbucks giftcard raffle! Contest ends 3/10/18

Free Starbucks giftcard raffle! Contest ends 3/10/18

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…

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122018Feb
FDA Commits to improving the recall process

FDA Commits to improving the recall process

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!

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92018Feb
UDI: Not just for manufacturers anymore

UDI: Not just for manufacturers anymore

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

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222017Mar
Compliance Dates for UDI Requirement

Compliance Dates for UDI Requirement

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….

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