Sam Brusco, Associate Editor05.24.24
Heuron, a South Korea-based artificial intelligence (AI) startup focused on brain and neurological disorders, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Heuron ICH non-contrast CT imaging analysis solution.
This FDA nod marks the first of an AI-based brain disorder analysis solution from Korea for computer-assisted triage and notification devices (CADt).
The AI solution automatically screens and signals potential intracranial hemorrhage cases using only non-contrast CT images. It quickly discerns emergency brain hemorrhages that need immediate attention and according to the company, captures the tiniest bleeds that escape human detection.
The company said Heuron ICH touts 86% sensitivity and 88% specificity. It’s the fifth solution from the company to earn FDA clearance. Heuron also reported the technology achieved FDA-required performance levels from clinical trials last year, which were conducted in collaboration with Mass General Brigham, affiliated with Harvard Medical School.
Donghoon Shin, CEO of Heuron, said, "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."
This FDA nod marks the first of an AI-based brain disorder analysis solution from Korea for computer-assisted triage and notification devices (CADt).
The AI solution automatically screens and signals potential intracranial hemorrhage cases using only non-contrast CT images. It quickly discerns emergency brain hemorrhages that need immediate attention and according to the company, captures the tiniest bleeds that escape human detection.
The company said Heuron ICH touts 86% sensitivity and 88% specificity. It’s the fifth solution from the company to earn FDA clearance. Heuron also reported the technology achieved FDA-required performance levels from clinical trials last year, which were conducted in collaboration with Mass General Brigham, affiliated with Harvard Medical School.
Donghoon Shin, CEO of Heuron, said, "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."