Posted by Michael Wonder on 09 Mar 2022
Insightec receives FDA IDE approval and breakthrough designation for NSCLC brain mets study
9 March 2022 - Designation and approvals mark key milestones in advancing Insightec blood brain barrier clinical roadmap using acoustic therapy.
Insightec today announced that it has received FDA approval of two pivotal investigational device exemptions for its Exablate Neuro system – one for primary non-small cell lung cancer that has metastasised 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 non-small-cell lung cancer treatment, helping to expedite its development and review.
