Cordance Medical, a forward-thinking medical device company specializing in enhancing liquid biopsy procedures by breaking the Blood-Brain Barrier (BBB), is delighted to announce that the U.S. Food and Drug Administration (FDA) has granted its NeuroAccess™ device the coveted Breakthrough Device Designation.

Designed for adults aged 22 and older who are dealing with known or suspected brain tumors, NeuroAccess offers a non-invasive method for healthcare professionals to elevate cell-free DNA (cfDNA) analytes in the bloodstream. This innovative procedure, known as SonoBiopsy™, complements the capabilities of existing liquid biopsy tests in the field of oncology.

The FDA's esteemed Breakthrough Device Designation is reserved for technologies that hold the promise of delivering superior treatments or diagnostics for life-threatening or severely debilitating conditions. This recognition underscores the significant potential of the NeuroAccess platform in addressing the unmet medical needs of brain tumor patients, offering a safe and minimally invasive means of obtaining molecular insights into their tumors. Under this program, Cordance Medical will receive priority review and accelerated interactions with the FDA.

The NeuroAccess technology utilizes focused ultrasound in conjunction with microbubbles to safely and temporarily breach the BBB. Designed to be portable, NeuroAccess aims to make SonoBiopsy procedures readily available in community clinics and hospitals. The FDA's Breakthrough Device Designation marks a noteworthy achievement for Cordance Medical and represents a pivotal moment for patients seeking more effective diagnostic solutions.

Source: prnewswire.com