Insightec's Exablate Prime Receives FDA and CE Mark for Philips MRI Integration
Key Insights
Insightec's Exablate Prime (search) system has been approved by the FDA and has received CE Mark for integration with select Philips MRI systems, expanding access to focused ultrasound treatments.
The Exablate Prime (search) system is now compatible 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.
Focused ultrasound, pioneered by Insightec, is an FDA-approved and CE Marked treatment for essential tremor (search) and some Parkinson's disease (search) symptoms, performed in a single outpatient procedure.
Insightec, a global healthcare company focused on therapeutic applications of acoustic energy, has announced that its Exablate Prime (search) system has received FDA approval and CE Mark for integration with certain Philips MRI systems. This clearance broadens the availability of non-invasive, MR-guided focused ultrasound treatments for patients with essential tremor (search) and Parkinson's disease (search).
Exablate Prime (search) is designed to integrate with select Philips 1.5T and 3.0T Ingenia systems, Philips Ambition 1.5T, Philips Elition 3.0T, as well as Philips MR 7700 3.0T. The focused ultrasound procedure is performed in a single outpatient visit, with many patients experiencing immediate improvement and minimal complications.
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 benefitting patients with cutting-edge care."
Focused Ultrasound Technology
Focused ultrasound, pioneered by Insightec, is FDA approved and CE Marked to treat essential tremor (search) and some symptoms of Parkinson's disease (search). The technology focuses sound waves, guided by MRI, to provide tremor treatment to patients with medication-refractory essential tremor and Parkinson's disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions.