Haifa, Israel–based Insightec — which has its U.S. headquarters in Miami — said the approval expands the accessibility of non-invasive magnetic resonance (MR)-guided focused ultrasound treatments for patients and healthcare providers.

The new clearances enable the integration of Exablate Prime with select, compatible Philips systems. Those include Philips 1.5T and 3.0T Ingenia systems, Philips Ambition 1.5T, Philips Elition 3.0T, as well as Philips MR 7700 3.0T.

Insightec develops focused ultrasound technology. Its Exablate Prime platform focuses MRI-guided sound waves to provide tremor treatment to patients with medication-refractory essential tremor and Parkinson’s disease. The procedure takes place in a single, outpatient procedure. According to the company, many patients show immediate improvement with minimal or no complications.