Friday, May 24, 2024
Heuron, a specialized medical AI startup based in South Korea, has recently announced a significant achievement: its non-contrast CT imaging analysis solution, Heuron ICH, has obtained FDA 510(k) clearance.
This marks a noteworthy milestone as the first FDA approval of an AI-based brain disorder analysis solution originating from Korea, specifically designed for computer-aided triage and notification devices (CADt).
Heuron ICH is an innovative AI solution meticulously crafted to automatically screen and alert potential cases of intracranial hemorrhage, relying solely on non-contrast CT images.
Its primary objective is to swiftly detect emergency brain hemorrhages that necessitate immediate attention, even capturing the smallest hemorrhages that may escape human detection. Notably, Heuron ICH boasts an impressive sensitivity of 86% and specificity of 88%, ensuring dependable and precise assistance in critical medical scenarios.
This milestone adds Heuron ICH to the esteemed list of FDA-cleared solutions from Heuron, including Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron Beta Amyloid, and Veuron-Brain-pAb3.
Presently, Heuron holds 15 domestic medical device approvals/certifications, four European CE (MDD) certifications, and several other international certifications.
CEO of Heuron, expressed his enthusiasm, stating, "Securing this product approval marks a significant milestone, facilitating our swift penetration into the U.S. market. Our commitment extends beyond this achievement as we endeavor to expand our portfolio of FDA-approved medical solutions.
We are dedicated to optimizing the utilization of Heuron's diverse offerings within U.S. clinical environments, particularly for emergency patient care."
Moreover, Heuron ICH met the stringent performance standards set by the FDA through clinical trials conducted last year in collaboration with Mass General Brigham, affiliated with Harvard Medical School.
Source: businesswire.com
