The FDA approved full-body MRI scans for conditional use with Medtronic’s deep brain stimulation (DBS) systems on Dec. 9.
The Medtronic DBS systems are the only ones approved for full-body MRI scans, according to the company. Approximately 43,000 people in the U.S. received DBS therapy.
Approval was based on the evaluation of DBS systems within 10 million simulated patient scans and more than 38,000 implant conditions.
The therapy is approved to treat disabling symptoms of essential tremor, Parkinson’s disease and chronic intractable primary dystonia.
Before this approval, patients could receive head scans at a low radiofrequency limit, but the DBS system was required to be turned off before the MRI scan. With the approval of full-body MRI scans, patients can now have increased radiofrequency power limits.