Health Canada Approval Granted to Insightec’s Exablate Prime System

Insightec has earned a Health Canada Medical Device License for its Exablate Prime system. Previously approved by the U.S. Food and Drug Administration (FDA), this latest authorization expands access to incisionless, magnetic resonance (MR)-guided focused ultrasound treatments.

Exablate Prime builds on the success of its predecessor, delivering shorter procedure times through efficient workflows and hardware. The system features a more intuitive user interface with guided workflows and automated steps that simplify planning, according to the company. Intelligent algorithms and refined visualization options provide enhanced insights that may better inform clinical decision-making. Additional upgrades, including improved cybersecurity and remote planning, further support a smoother, more productive clinical workflow. Health Canada’s approval also expands MR system compatibility.  Exablate Prime can now be used with GE HealthCare and Siemens, as well as select Philips MR systems at Canadian treatment centers. 

“This Medical Device License from Health Canada marks an important step in expanding access to advanced focused ultrasound treatment for people living with Parkinson’s disease and essential tremor in Canada,” Insightec Chairman/CEO Maurice R. Ferré, M.D., said. “By bringing Exablate Prime to more treatment centers, we aim to support clinicians with an enhanced platform and help more patients access incisionless treatment options today, while continuing to advance focused ultrasound for the future.”

Focused ultrasound is delivered in a single, outpatient procedure, with many patients experiencing immediate improvement and minimal or no complications. To date, more than 30,000 patients have been treated with Insightec’s Exablate technology for various movement disorder indications at 214 centers worldwide.

Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company’s Exablate Neuro platform focuses sound waves— safely guided by MRI—to provide 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. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas; Frankfurt, Germany; Shanghai; and Tokyo.