Guidance Outlines Testing Parameters For MRI-Compatible Devices
This article was originally published in The Gray Sheet
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.
You may also be interested in...
US FDA put out a class I recall notice and sent health-care providers a warning to avoid using Monteris Medical's NeuroBlate probes after at least one patient bled to death after the probe overheated. The agency says it can't conclude for sure the patient death was caused by the device, which is used to support brain surgery.
FDA has partnered with the Med Institute, part of Cook Group, to spend the next three years trying to understand what standards could be used to determine whether a device is MRI compatible.