Keya Medical's Proprietary AI Imaging System 'CuraRad-ICH' Receives FDA 510(k) Clearance, Marking First-of-its-Kind Approval for a Chinese-Origin AI Diagnostic Tool

On April 14, 2020, Beijing time, Keya Medical, an AI healthcare company that had just secured China’s first Class III medical device certificate for an AI product with its “DeepVessel FFR,” received further good news from the U.S. Food and Drug Administration (FDA):“CuraRad-ICH,” an AI-powered imaging diagnostic system for hemorrhagic stroke developed based on its proprietary patented technology, has obtained U.S. FDA 510(k) clearance and is approved for official market launch and sales in the United States.

It is reported that,Keya Medical’s “CuraRad-ICH” is the first AI-based imaging diagnostic system developed with original Chinese technology to receive FDA approval.. The approval of this product not only signifies that domestic artificial intelligence technology has gained recognition from the most stringent regulatory authorities abroad, but also demonstrates that Chinese AI healthcare companies, represented by Keya Medical, have achieved international leadership in the development of application technologies across multiple clinical scenarios, marking a milestone event in the development of China’s artificial intelligence industry.

In 2018, Keya Medical’s “DeepVessel FFR,” a non-invasive coronary functional assessment product based entirely on deep neural networks, became the first imaging AI product in China to receive EU CE certification. In January 2020, Keya Medical’s “DeepVessel FFR” became the first imaging AI product in China to obtain a Class III medical device registration certificate from the National Medical Products Administration (NMPA). Currently, Keya Medical’s artificial intelligence imaging diagnostic system for hemorrhagic stroke, “CuraRad-ICH,” has received FDA clearance.Since then, Keya Medical has officially become the only AI medical imaging company in the world to hold triple certifications from China’s NMPA, the EU’s CE, and the US FDA.。

Stroke, also known as cerebrovascular accident, is an acute cerebrovascular disease characterized by brain tissue injury resulting from the sudden rupture of cerebral blood vessels or from vascular occlusion that prevents blood flow to the brain. Stroke has become one of the top three causes of mortality among adults and is the leading cause of disability in this population.

Keya Medical's“CuraRad-ICH”It is an AI-powered medical imaging analysis software dedicated to providing rapid alerts for cerebral hemorrhage in stroke patients. By leveraging deep learning technology, it accurately and swiftly screens for acute cerebral hemorrhage cases and seamlessly integrates with hospital PACS systems. The system automatically elevates the priority of cerebral hemorrhage cases, prompting radiologists to prioritize diagnostic assessments, thereby effectively reducing diagnosis and treatment time for stroke patients and saving lives.

In the daily operations of U.S. emergency departments and radiology imaging centers, shortages of physician resources frequently lead to backlogs in image interpretation. AI-powered early warning systems can reduce the current 2–24 hour waiting time for stroke patients to under one minute, enabling timely treatment and holding significant clinical importance.

In clinical trials conducted across 296 imaging centers in 48 U.S. states, the CuraRad-ICH analysis and processing software achieved a sensitivity of 91% and a specificity of 93%, with an average alert generation time of only 43 seconds. This significantly reduced the diagnosis and treatment time for patients with hemorrhagic stroke, earning consistent recognition from clinical experts.

The successful FDA approval fully demonstrates the U.S. Food and Drug Administration’s strong recognition of the product’s clinical value and accuracy. Currently, Keya Medical and its partners have established strategic collaborations with multiple large imaging center groups and PACS vendors in North America to expedite the product’s market launch.