Insightec Wins FDA, EU Nods for Exablate Prime on Philips MR Systems

Insightec has won U.S. Food and Drug Administration (FDA) approval and CE mark of its Exablate Prime system with certain Philips MR (magnetic resonance) systems.

Now, Exablate Prime can be integrated with select, compatible Philips 1.5T and 3T Ingenia, Ambition 1.5T, Elition 3T, and Philips MR 7700 3T systems. The approval boosts accessibility of non-invasive MR-guided focused ultrasound treatments for patients and healthcare practitioners.

Exablate Prime was rolled out in January 2024. Its improvements include:

• A user interface with guided workflows, automated steps, and a streamlined UI
• Intelligent algorithms for one-click skull-density-ratio (SDR) calculations, automatic fusion and AC/PC identification, and efficient no-pass region detection
• Temperature-driven control enabled by an accurate temperature prediction algorithm
• Precise targeting and lesion shaping with sub-millimetric targeting control and advanced shaping masks
• Plane thermal spot visualization, cumulative thermal dose overlays
• Improved cybersecurity, PACS connectivity, remote planning, and troubleshooting
• Automatic MR scan acquisition, intelligent targeting tools, and larger MR data sets in one planning session
• An optional, upgraded 3T head coil

Insightec pioneered focused ultrasound. It’s FDA approved and CE marked to treat essential tremor and some symptoms of Parkinson’s disease. The single, outpatient procedure showed immediate improvement with minimal or no complications, the company said.

“This is the result of a dedicated collaboration between Insightec and Philips,” said Insightec chairman and CEO Maurice R. Ferré. “We are proud of adding Philips to our extended family. Our goal is to make these groundbreaking solutions accessible to more treatment centers, ultimately benefitting patients with cutting-edge care.”