Israeli device maker InSightec landed a green light from the Chinese Food & Drug Administration for its ExAblate MRI-guided focused ultrasound therapy, with an indication to treat non-cancer-causing tumors in the uterus.
These tumors, called uterine fibroids, occur in more than 20% of women of childbearing age, according to the company. ExAblate is an incision-free treatment that uses ultrasound frequencies to ablate tumors.
The device is designed to treat bone tumors, brain disorders, uterine fibroids, uterine thickening and to help with pain management. It has won different indications in different markets around the world and in 2012 landed a green light in the U.S. to treat pain-inducing bone tumors.
Chinese approval was based on clinical trials at Peking Union Medical College Hospital and China Medical University First Hospital.
"We are extremely proud to have received CFDA approval for ExAblate which is another vote of confidence in ExAblate’s high safety profile and excellent outcomes," said InSightec CEO Dr. Kobi Vortman in prepared remarks.
