Tuesday, 16 August 2022

Insightec bags CDSCO approval for neurosurgery platform, Exablate 4000

20 September 2021 | News

To enable treatment of Essential Tremor, Tremor-dominant Parkinson's Disease and neuropathic pain

Image Credit: https://www.insightec.com/

Image Credit: https://www.insightec.com/

Israel and US-based Insightec has received market approval from the Central Drugs Standard Control Organization (CDSCO) for its incision-less neurosurgery platform, the Exablate 4000.


The Exablate 4000 (Exablate Neuro) platform uses MR-guided focussed ultrasound to precisely ablate a small target deep within the brain without incisions. The approval will enable the treatment of patients in India living with Essential Tremor, Tremor-dominant Parkinson's Disease and neuropathic pain. 


"This approval adds to the growing recognition of the value of Focused Ultrasound for global healthcare systems," commented Maurice R Ferré MD, Insightec CEO and Chairman of the Board of Directors. "More importantly, expanded access to our technology is helping to transform the lives of people living with debilitating medical conditions."


"This technology offers appropriate patients immediate tremor control with a less invasive procedure that requires no incisions or anaesthesia with minimal complications," said Prof Paresh Doshi, Director of Neurosurgery, Jaslok Hospital and Research Centre and Group Advisor Functional Neurosurgery, Apollo Group of Hospitals, President of The Neuromodulation Society of India and Past President of the Indian Society for Stereotactic and Functional Neurosurgery. "Global clinical studies have demonstrated the procedure as approved is safe and helps patients to regain daily function."


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