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Re: midastouch017 post# 1822

Saturday, 12/04/2021 8:27:35 AM

Saturday, December 04, 2021 8:27:35 AM

Post# of 1834
FDA clears Insightec's MRI-guided sound wave technology to treat prostate cancer

by Andrea Park | Dec 3, 2021 11:20am

https://www.fiercebiotech.com/medtech/fda-clears-insightec-s-mri-guided-sound-wave-technology-to-treat-prostate-cancer

The prostate cancer-focused technology’s FDA clearance comes just a month after Insightec racked up yet another regulatory approval for its Exablate Neuro system. The new indication allows the brain-centric version of the focused ultrasound tech to be used to treat patients with advanced Parkinson’s disease who are experiencing issues with mobility, rigidity and dyskinesia, a complication that causes involuntary muscle movements.

That FDA approval adds to Exablate Neuro’s other indications, which OK the system for use in treating tremors in patients with tremor-dominant Parkinson’s or medication-resistant essential tremor.

Though Exablate Neuro has become Insightec’s flagship product since its first FDA nod in 2016, Exablate Prostate marks a return to the Israeli company’s original focus outside the brain. Dating back to 2004, Insightec initially locked down the agency’s approval to apply its Exablate tech toward the treatment of uterine fibroids and metastatic bone cancer pains.