SAN JOSE, Calif.--(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)..

加利福尼亚州圣何塞（商业新闻短讯）--韩国专注于大脑和神经系统疾病的专业医疗AI初创公司Heuron宣布，其非对比CT成像分析解决方案Heuron ICH已获得FDA 510（k）许可。这标志着FDA首次批准韩国用于计算机辅助分类和通知设备（CADt）的基于AI的脑部疾病分析解决方案。。

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.

Heuron ICH是一种先进的人工智能解决方案，旨在仅依靠非对比CT图像自动筛查和发出潜在颅内出血病例的信号。它的主要功能是迅速识别需要立即注意的紧急脑出血，甚至捕捉通常无法被人类发现的最微小的出血。

Notably, Heuron ICH boasts a sensitivity of 86% and specificity of 88%, ensuring reliable and accurate assistance in critical medical scenarios..

值得注意的是，Heuron ICH具有86%的敏感性和88%的特异性，确保在紧急医疗情况下提供可靠和准确的帮助。。

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..

Heuron ICH成为继Veuron-Brain-mN1，Veuron-Brain-pAb，Heuronβ-淀粉样蛋白和Veuron-Brain-pAb3之后，Heuron第五个获得FDA批准的解决方案。目前，Heuron拥有15项国内医疗器械批准/认证、4项欧洲CE（MDD）认证以及其他各种国际认证。。

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.

Heuron首席执行官Donghoon Shin表示，“获得该产品的批准标志着一个重要的里程碑，有助于我们迅速进入美国市场。随着我们努力扩大FDA批准的医疗解决方案组合，我们的承诺超越了这一成就。我们致力于优化Heuron在美国的各种产品的利用。

clinical environments, particularly for emergency patient care.'.

临床环境，特别是紧急病人护理。”。

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.

此外，Heuron ICH通过去年与哈佛医学院附属的Mass General Brigham合作进行的临床试验，成功达到了FDA要求的性能水平。

About Heuron

关于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.

Heuron Co.，Ltd.成立于2017年，是神经退行性疾病和紧急中风护理的医疗AI解决方案的先驱。Heuron的尖端软件有助于精确诊断阿尔茨海默氏病和帕金森氏病等疾病，同时通过StroCare Suite™加速中风治疗。Heuron在全球范围内开展合作，努力通过人工智能驱动的诊断来增强大脑健康，应对人口老龄化带来的挑战。