Canadian healthcare regulators approved InSightec’s ExAblate ultrasound system, clearing the device for use against 2 different diseases. Health Canada granted ExAblate indication to break up benign uterine tumors and to alleviate painful symptoms of metastatic bone tumors.
The Tirat Carmel, Israel-based company specializes in ultrasound ablation technology. InSightec’s ExAblate uses a highly focused beam, guided by an MRI, to break up tissue. The tumor-busting procedure uses non-iodizing radiation and alleviates symptoms without surgical removal.
The ExAblate device has won different indications in different markets around the world, indicated to treat bone tumors, brain disorders, uterine fibroids, uterine thickening and to help with pain management.
In 2012, ExAblate was cleared in the U.S. to treat pain-inducing bone tumors, and last month Chinese regulators cleared the device for uterine solid-tumor treatment.
"Health Canada’s approval is another vote of confidence in ExAblate’s high safety profile and excellent outcomes," CEO Dr. Kobi Vortman said in prepared remarks. "It once again highlights InSightec’s firm commitment to expand clinical indications in gynecology as well as in oncology and neurosurgery."