InSightec lands new FDA approval for Exablate Neuro

MR-guided focused ultrasound (MRgFUS) developer InSightec has received U.S. Food and Drug Administration (FDA) approval for the use of its Exablate Neuro device with 1.5-tesla MR scanners in treating essential tremor.

As was the case with the initial FDA approval for Exablate Neuro with 3-tesla scanners in July 2016, the latest FDA approval is for the treatment of essential tremor in patients who have not responded to medication, according to the vendor. The MR head coil uses focused ultrasound waves to target and ablate the ventral intermediate nucleus of the thalamus; MRI guidance provides real-time treatment monitoring, InSightec said.

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