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[Insightec in PR Newswire] INSIGHTEC RECEIVES FDA IDE APPROVAL AND “BREAKTHROUGH” DESIGNATION FOR NSCLC BRAIN METS STUDY AND IDE APPROVAL FOR LIQUID BIOPSY STUDY

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March 11, 2022
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HAIFA, Israel & MIAMI, March 9, 2022 /CNW/ — Insightec, a worldwide healthcare firm devoted to utilizing acoustic vitality to remodel affected person care, at present introduced that it has acquired FDA approval of two pivotal investigational gadget exemptions (IDE) for its Exablate Neuro system – one for major non-small cell lung most cancers (NSCLC) that has metastasized to the mind at the side of standard-of-care Keytruda®, and one for enhanced efficacy of liquid biopsy for recurrence monitoring of sufferers with major mind most cancers. The FDA has additionally granted “Breakthrough Machine” designation for the NSCLC remedy, serving to to expedite its improvement and overview.

Learn extra here.

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