Insightec has announced FDA approval and CE mark for its Exablate Prime system for use with specific Philips MRI systems, expanding the reach of non-invasive, magnetic resonance (MR)-guided focused ultrasound treatments.
The clearances enable the integration of Exablate Prime with Philips 1.5T and 3.0T Ingenia systems, Philips Ambition 1.5T, Philips Elition 3.0T, as well as Philips MR 7700 3.0T. This collaboration between Insightec and Philips aims to make the technology more accessible to treatment centers, ultimately benefiting patients.
How Exablate Prime Works
Insightec's Exablate Prime platform employs MRI-guided focused ultrasound to treat tremors in patients with medication-refractory essential tremor and Parkinson’s disease. The procedure is conducted in a single outpatient visit, with many patients experiencing immediate improvement and minimal complications. Focused ultrasound has already received FDA approval for treating both sides of the body.
Executive Insights
"This is the result of a dedicated collaboration between Insightec and Philips," said Maurice R. Ferré, Insightec Chief Executive Officer and Chairman of the Board. "We are proud of adding Philips to our extended family. Our goal is to make these groundbreaking solutions accessible to more treatment centers, ultimately benefiting patients with cutting-edge care."
Market Presence and Future Applications
Insightec currently has over 160 systems installed worldwide, with nearly 20,000 commercial applications as of earlier this year. The company continues to research future applications in the neuroscience space, supported by a recent $150 million funding round to advance its incision-less, ultrasound-based neurosurgery technology.
