Tiger BufordYour Orthopedic Industry Expert (free today)

Orthopedics is waking up to metal implant allergies that is a contributor to revisions.

6 Oct 2024 · 1 min

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Metal allergies to orthopedic implants cause revision surgeries but have been largely ignored. The FDA recently flagged two new implant designs as breakthrough devices. A company is developing a test to identify patients at risk for or already having reactions to metal implants.

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So it really is underrecognized in that area. It is beginning, I think, to be more recognized. There have been several publications more recently. And, you know, we are seeing comments from folks like the FDA talking about needing a better understanding of the host response, which is essentially where our company's focused. So the FDA recently designated two new implant designs as breakthrough devices. We know this is seen as an issue by the FDA., and we're looking to launch this product in the US to help identify patients who either are at risk of having a hypersensitivity reaction or experiencing a current hypersensitivity reaction.