The FDA has granted the South Korean medical AI firm Heuron 510(k) approval for its Heuron ICH solution, a cutting-edge tool for identifying cerebral bleeding by analyzing non-contrast CT scans.
This achievement represents the first FDA approval for a Korean AI-driven brain disorder analysis solution within the realm of computer-aided triage and notification devices (CADt). Heuron ICH has an 86% sensitivity and 88% specificity, making it ideal for quickly identifying brain hemorrhages that require medical attention. The sophisticated AI is especially good at spotting tiny bleedings that a human eye would overlook. Clinical trials, conducted in collaboration with Mass General Brigham, a Harvard Medical School affiliate, were crucial in demonstrating the solution's performance and securing FDA approval.
Founded in 2017, Heuron focuses on creating artificial intelligence (AI) solutions for neurodegenerative illnesses and acute stroke treatment. The company's StroCare Suite expedites stroke therapy and helps diagnose Parkinson's and Alzheimer's illnesses. Heuron plans to expand its portfolio of FDA-approved medical solutions and optimize their use in US clinical settings, particularly for emergency patient care. The FDA clearance for Heuron ICH adds to the company’s growing list of approvals, including four European CE (MDD) certifications and 15 domestic medical device approvals.
