Insightec said today it won FDA approval for its Exablate Neuro model 4000 system, now cleared for use with 1.5 Tesla magnetic resonance imaging for treating essential tumor in patients non-responsive to medication.
The Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.
“Being able to bring MR-guided focused ultrasound to hospitals that have 1.5T MRIs will enable more essential tremor patients to have access to this non-invasive treatment option using Insightec’s ground-breaking technology,” CEO & board chair Dr. Maurice Ferré said in a press release.
The company won a nod from the FDA for the Exablate Neuro for use with 3.0 T MRI systems last July.
Last month, Insightec said that the 1st patient had been treated in a feasibility trial exploring the use of its Exablate Neuro system in treating benign centrally-located intracranial tumors in pediatric and young adults.