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Guidance Outlines Testing Parameters For MRI-Compatible Devices

The new document details how companies can test passive medical devices, such as orthopedic implants and stents, against risks from radiofrequency-induced heating during an MRI scan.

FDA has finalized a guidance that tells device manufactures how they can evaluate whether multi-configuration, passive medical devices are compatible with MRI scanners.

Implanted medical devices, including orthopedic implants and cardiovascular stents, are often made of electrically conductive materials and configured in a way that could cause them heat up in response to...

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