Heuron Gets FDA Green Light for Stroke Triage and Notification Solution
May 23 2024 - 4:13PM
Business Wire
Heuron, a specialized medical AI startup focused on brain and
neurological disorders based in South Korea, announced that its
non-contrast CT imaging analysis solution, Heuron ICH, has received
FDA 510(k) clearance. This marks the first FDA approval of an
AI-based brain disorder analysis solution from Korea for
computer-aided triage and notification devices (CADt).
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Heuron ICH Worklist (Graphic: Business
Wire)
Heuron ICH is an advanced AI solution designed to automatically
screen and signal potential cases of intracranial hemorrhage,
relying solely on non-contrast CT images. Its primary function is
to swiftly discern emergency brain hemorrhages that require
immediate attention, even capturing the minutest hemorrhages that
often elude human detection. Notably, Heuron ICH boasts a
sensitivity of 86% and specificity of 88%, ensuring reliable and
accurate assistance in critical medical scenarios.
Heuron ICH becomes the fifth solution from Heuron to receive FDA
clearance, following Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron
Beta Amyloid, and Veuron-Brain-pAb3. Currently, Heuron holds 15
domestic medical device approvals/certifications, four European CE
(MDD) certifications, and various other international
certifications.
Donghoon Shin, CEO of Heuron, expressed, "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."
Additionally, Heuron ICH successfully achieved the performance
levels required by the FDA through clinical trials conducted last
year in collaboration with Mass General Brigham, affiliated with
Harvard Medical School.
About Heuron
Heuron Co., Ltd., founded in 2017, pioneers medical AI solutions
for neurodegenerative diseases and emergency stroke care. Heuron’s
cutting-edge software aids precise diagnosis of conditions like
Alzheimer’s and Parkinson’s disease while expediting stroke
treatment through the StroCare Suite™. Collaborating globally,
Heuron strive to enhance brain health through AI-driven
diagnostics, addressing challenges posed by aging populations. For
more information, please visit: https://iheuron.com/en/
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Eunsil Kang Chief Strategy Officer christina.kang@iheuron.com,
heuron@iheuron.com