Keya Medical

What the company is

Keya Medical (科亚医疗) is a Chinese medical artificial-intelligence company founded in January 2016. It describes itself as the first company in China to hold a class III AI medical device certificate ^[1]. In China's device regulation, class III is the highest risk category and the one with the strictest review requirements, so such a certificate means the software has gone through the full registration route rather than being used only in research settings.

The company calls itself a national high-tech enterprise and says it takes part in the Beijing engineering research centre for intelligent cardiovascular diagnosis and treatment ^[2]. Its business focuses on applying big data and AI to the diagnosis and treatment of coronary heart disease ^[2].

Products

Its core product is Shenmai FFR, whose name refers to fractional flow reserve (FFR) — a pressure-based index doctors use to judge whether a narrowing in a coronary artery actually limits blood flow to the heart muscle, as opposed to merely looking narrow on an image. In October 2016 Shenmai FFR began the first domestic clinical trial of its kind ^[3].

A second line of work is stroke imaging. Its haemorrhagic stroke imaging system CuraRad-ICH was cleared by the US Food and Drug Administration in April 2020 ^[3]. "ICH" stands for intracranial haemorrhage, bleeding inside the skull. On emergency brain imaging the central question is often whether a patient is bleeding or is having an ischaemic stroke caused by a blocked vessel, because the two conditions call for opposite treatments, and software that flags bleeding early supports that triage.

Certifications and recognition

The company says it was the first to hold six certifications at once: China's NMPA, the US FDA, the EU CE mark, Singapore's HSA, Hong Kong, China and Taiwan, China ^[2]. Five of its products obtained class II certificates in 2021 ^[3].

It also took part in drafting industry standards issued by China's National Medical Products Administration, and won first prize in a medical AI competition run by the National Health Commission ^[2]. Three of its products were recognised under Beijing's new technology and new product programme in February 2022 ^[3].

Working with hospitals

In August 2021 the company set up an AI joint laboratory with Beijing Anzhen Hospital ^[3]. Arrangements of this kind pair a hospital's imaging and clinical records, and its clinicians' judgement, with a company's engineering team, so that models are developed and checked against real patient data rather than only against curated research datasets.

Where it sits

In December 2024 the company said its overseas business revenue had grown more than threefold year on year ^[3]. The figure was given for overseas business rather than for the company as a whole, which makes markets outside mainland China visible in its own account of how the business is developing. Read together with the six-market certification claim and the FDA clearance for CuraRad-ICH ^[2][3], it points to a company that has treated regulatory approval in several jurisdictions, not just at home, as part of its plan.