INSIGHTEC SUBMITS PRE MARKET APPLICATION OF EXABLATE NEURO TO THE JAPANESE PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA)
INSIGHTEC, the leader in MR guided Focused Ultrasound (MRgFUS) therapy announced today that it has submitted an application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to approve its Exablate Neuro platform. The approval submission was based on data collected globally.
Exablate Neuro uses high intensity focused ultrasound to thermally ablate the target tissue and continuous MRI to visualize the anatomy, plan treatment and monitor treatment outcomes. In the brain, MRgFUS is used to perform neuro-functional surgery through intact skull.
“The current submission represents an important milestone in turning MRgFUS technology a standard of care for patients with neurological disorders,” said Maurice R. Ferré, MD, CEO and Chairman of INSIGHTEC. “INSIGHTEC will continue to invest in the development of its technology for a wider range of clinical indications.” Dr. Ferré concluded.
“Ultimately, our goal is to make our Exablate Neuro treatment accessible for Japanese people suffering from neurosurgical disorders, so they can take advantage of this high-end non-invasive treatment option,” said Yair Bauer, INSIGHTEC’s Country Manager for Japan. “We are focused on meeting unmet medical needs for Japanese patients,” he concluded.