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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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HAIFA, Israel & MIAMI, March 9, 2022 /CNW/ — Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that it has received FDA approval of two pivotal investigational device exemptions (IDE) for its Exablate Neuro system – one for primary non-small cell lung cancer (NSCLC) that has metastasized to the brain in conjunction with standard-of-care Keytruda®, and one for enhanced efficacy of liquid biopsy for recurrence monitoring of patients with primary brain cancer. The FDA has also granted “Breakthrough Device” designation for the NSCLC treatment, helping to expedite its development and review.

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The post [Insightec in PR Newswire] Insightec receives FDA IDE approval and “Breakthrough” designation for NSCLC Brain Mets Study and IDE approval for Liquid Biopsy Study appeared first on OurCrowd Blog.

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