Insightec announced today that it received FDA approval and CE mark for its Exablate Prime system with certain Philips MR systems.
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.
Focused ultrasound has FDA approval to treat both sides of the body. Last fall, the company received positive coverage for its essential tremor therapy. Insightec announced in June that it raised $150 million to further support its incision-less, ultrasound-based neurosurgery technology.
“This is the result of a dedicated collaboration between Insightec and Philips,” said Insightec Chief Executive Officer and Chairman of the Board, 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.”
The company also has research for future applications in the neuroscience space. It already has more than 160 systems installed worldwide, with use in nearly 20,000 commercial applications as of earlier this year.
