Insightec Gets Europe’s CE Clearance For Non-Invasive MRI-Guided Ultrasound Tech

Insightec, a Tirat Carmel-based medical technology company, and Siemens Healthineers, a leader in medical technology and diagnostic and therapeutic imaging, announced in a statement that they have received Europe’s CE mark for the Exablate Neuro, which uses focused ultrasound for treatments deep within the brain with no surgical incisions, and its compatibility with Magnetom Skyra, Prisma and Prisma Fit scanners from Siemens Healthineers.

The CE mark includes approval for treatment of medication-refractory essential tremor, tremor-dominant Parkinson’s disease and neuropathic pain, the companies said. They received FDA approval in October for the Exablate Neuro compatibility with MRI scanners from Siemens Healthineers to treat medication-refractory essential tremor.

“Insightec and Siemens Healthineers are working in partnership to transform patient care,” said Maurice R. Ferré, MD, Insightec Chief Executive Officer and Chairman of the Board. “This milestone is key to expanding patient access to incisionless brain surgery using focused ultrasound.”

“We welcome a new era of advanced MRI-guided therapy in the neuro space,” said Arthur Kaindl, Ph.D., Head of Magnetic Resonance at Siemens Healthineers. “The cooperation with Insightec is the latest example of our open innovation strategy. Through close collaboration with clinical experts and partner companies we make great strides in expanding precision medicine.”

Earlier this year, Insightec was among 15 Israeli companies on Fast Company’s “World’s Most Innovative”for revolutionizing surgeries for treating essential tremor, a nerve disorder characterized by uncontrollable shaking, with their non-invasive MRI-guided ultrasound technology. It raised $150 million in a Series E funding round in January.

Insightech has a second headquarter in Miami, Florida, with offices in Dallas, Tokyo, and Shanghai.