Pre-market approval of INSIGHTEC’s device, for Parkinson’s disease, submitted to Japanese PMDA

INSIGHTEC®, a global medical technology innovator of incisionless surgery, announced that it has submitted a Pre-Market Approval (PMA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for its Exablate Neuro (Exablate 4000) device for treating advanced Parkinson’s Disease patients suffering from mobility, rigidity or dyskinesia effects.

The Exablate Neuro, which uses focused ultrasound together with MR imaging to treat deep within the brain with no incisions, is intended to improve motor function and reduce dyskinesia. Dyskinesia is one of the debilitating symptoms that presents as uncontrolled, involuntary movement of the arms and/or legs. Dyskinesia often occurs as a side effect of medication in Parkinson’s Disease patients.

“INSIGHTEC is committed to supporting research that extends the applications and potential of focused ultrasound, to improve the lives of people living with Parkinson’s disease with a much less invasive approach than conventional surgery,” commented Maurice R. Ferré MD, INSIGHTEC’S CEO and Chairman of the Board of Directors.

The Exablate Neuro is currently approved by MHLW to treat medication-refractory essential tremor. There are currently seven medical institutions in Japan performing the incisionless focused ultrasound treatment for essential tremor on a routine basis.

About Pharmascroll:

Pharmascroll is a diligent business consulting and market research firm focused solely towards pharmaceutical markets. The company consults and researches in majorly chronic disease indications prevalent across the globe. The research conducted by Pharmascroll analysts is targeted to provide analytical and logical answers to the key business questions of the pharmaceutical and medical insights teams and to make better informed business decisions with the detailed relevant information available.

To read more news about Parkinson’s disease indication, visit https://pharmascroll.com/news-category/parkinsons/

News Source: INSIGHTEC Website

Image Source: https://www.fusfoundation.org/news/129-press-room/2103-first-patient-treated-with-focused-ultrasound-in-parkinson-s-disease-pivotal-trial