The blood-brain barrier (BBB) serves as a protective shield for the brain, strictly controlling the substances that can move from the bloodstream into the brain. This barrier not only keeps harmful molecules at bay but also limits the reach of potentially beneficial drugs and diagnostic markers, thus preventing measurement using a blood test. Now, a non-invasive medical device that reversibly opens the BBB exactly where it is needed can pave the way for precision medicine, delivering drugs, and measuring circulating biomarkers via a blood test to diagnose and track brain diseases.

Cordance Medical (Mountain View, CA, USA) has developed the NeuroAccess device aimed at adults aged 22 and older who have known or suspected brain tumors. The device allows healthcare experts to non-invasively raise the levels of cell-free DNA (cfDNA) in the bloodstream, enhancing the performance of liquid biopsies for oncology. The device employs focused ultrasound coupled with microbubbles to safely and temporarily open the BBB. With its portable design, the goal is for the NeuroAccess device to be used for SonoBiopsy procedures in various healthcare settings, from community clinics to hospitals.

Earlier in the year, initial studies confirmed the safety and feasibility of using the SonoBiopsy technique in patients with brain tumors. Previous research using focused ultrasound and microbubbles to open the BBB has shown promise for treating various neurological conditions, such as glioblastoma, brain metastasis, Alzheimer's, and Parkinson's. Now, the U.S. Food and Drug Administration has given the NeuroAccess device a Breakthrough Device Designation, indicating its transformative potential for meeting the medical needs of brain tumor patients by offering a safer way to obtain molecular characterization of their tumors.

"This Breakthrough Device Designation from the FDA is a pivotal milestone for Cordance Medical and for patients requiring more efficacious diagnostic solutions," said Ryan Dittamore, CEO of Cordance Medical. "We are keen to continue our clinical trials and to collaborate closely with the FDA to bring this groundbreaking technology to market." 

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