FDA Expands Approval of Insightec’s Exablate

Insightec gained an expanded FDA approval for its Exablate Neuro platform, this time allowing patients to receive treatment for essential tremor (a neurological disorder that causes involuntary shaking) on the other side of the brain at least nine months after treatment on the first side.

The system uses magnetic resonance imaging to identify areas of the brain responsible for the symptoms and then applies a focused ultrasound beam to heat and destroy targeted tissue.

The expanded approval is supported by results from a study that showed immediate significant reduction in tremor, which was sustained through at least six months of follow-up, consistent with treatment on the first side, the company said.

The Exablate Neuro system first received FDA approval in 2016.