StoryRegulatory

Insightec secures Health Canada approval for Exablate Prime system with improved workflows and remote planning

InsightecExablate Neuro / Exablate Prime

Insightec announced receipt of a Medical Device License from Health Canada for Exablate Prime, the latest generation of its MR-guided focused ultrasound system. Exablate Prime includes improved user interfaces, guided workflows for operators, enhanced visualization, improved cybersecurity, and remote treatment planning capabilities, plus compatibility with Philips MR systems alongside existing GE and Siemens support.

  • Health Canada approval comes after FDA approval in the US, expanding access to focused ultrasound treatment for tremor in Canada.
  • Exablate Prime features remote treatment planning and guided operator workflows to reduce procedure time and improve consistency.
  • The system now supports Philips MR scanners in addition to GE and Siemens systems, expanding hospital compatibility.
  • Company has treated 30,000+ patients at 214 treatment centers globally, with strong adoption in the US, EU, and Japan.
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