FDA Approves Breakthrough Designation for Liquid Biopsy Study

FDA Approves Breakthrough Designation for Liquid Biopsy Study

Designation and approvals mark key milestones in advancing Insightec Blood Brain Barrier (BBB) clinical roadmap using Acoustic Therapy.   Insightec 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 […]

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Source: eTurboNews

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