China grants its first class III certificate to an AI medical device

Background

A coronary stenosis is a narrowing of an artery that supplies the heart muscle. The presence of a narrowing does not by itself mean that blood flow has fallen far enough to starve the muscle of oxygen. What clinicians need to answer is a functional question: does this particular stenosis cause ischaemia? Fractional flow reserve (FFR) is a measure used for that question, expressing how much a narrowing limits flow by comparing the pressure on either side of it. The conventional measurement is invasive, requiring a pressure wire to be passed into the coronary artery during angiography. Software that could reach a similar judgement from ordinary imaging, without entering the artery, would spare patients an invasive step.

What happened

Keya Medical dates the approval to 14 January 2020, when its coronary flow reserve calculation software received China's first class III certificate for an AI medical device^[1]. The approved product was Shenmai FFR, used for non-invasive assessment of whether a coronary stenosis causes ischaemia^[1].

Chinese device registration is organised by risk, and class III is the tier reserved for the highest-risk devices, with the most demanding review. A certificate in that tier treats the software as a device in its own right: the object under review is the algorithm and its stated clinical use, not a piece of hardware to which the software is attached. Calling this the first class III certificate for an AI medical device therefore says something about the review process as much as about the product — a route that had not previously been completed now had a precedent.

Key details

The approval was not sudden. The same product had entered the National Medical Products Administration's special approval channel for innovative devices in April 2018, about 21 months before the certificate^[2]. That gap describes the review period between entering the channel and reaching a decision.

There is a second timeline running alongside it. The product had already held the EU CE mark since August 2018, so the Chinese certificate was one step in a multi-country sequence rather than a first regulatory encounter^[2]. Read together, the two timelines place the January 2020 decision in the middle of a longer registration effort, not at its beginning.

After the certificate

Approval and clinical use are separate problems for a software device. In September 2020 the product obtained a reimbursement code, completing the path from approval to billable clinical use^[2]. For software of this kind, whether it can enter a hospital's billing and ordering workflow often decides whether it is actually used.

The company was also filing elsewhere. It received a US FDA clearance for its stroke imaging product CuraRad-ICH in April 2020, three months after the Chinese certificate^[2].

Why it matters

Keya Medical's homepage frames the certificate as a new starting point for smart healthcare and a milestone in AI device review^[1]. The concrete content of the case is a sequence: entry into the innovative-device channel, registration approval in the highest risk tier, and then a reimbursement code that makes the product billable. Each of those steps had to be completed for the software to reach patients, and the record of them shows what the whole route looks like for a diagnostic algorithm treated as a medical device.