Insightec has received a Medical Device License from Health Canada for the company's MR-guided focused ultrasound system, Exablate Prime.
The system has already been approved by the U.S. Food and Drug Administration (FDA), the company said. This approval expands access for its use on patients in Canada living with essential tremor.
Exablate Prime, Insightec’s MR-guided focused ultrasound system.Insightec
Exablate Prime features an intuitive user interface with guided workflows and automated steps that aim to simplify planning. It also has intelligent algorithms and refined visualization options to provide enhanced insights. Additional upgrades include improved cybersecurity and remote planning. The Health Canada approval also expands the system's MRI compatibility.
Exablate Prime is now available for use with select MRI systems from Philips, in addition to those from GE HealthCare and Siemens Healthineers, at treatment centers throughout Canada.
