Shenmai FFR (DVFFR)

What it is

Shenmai FFR (DVFFR) is a coronary flow reserve calculation package developed by 科亚医疗: it analyses CT coronary angiograms with deep learning^[3]. The question it is built to answer is whether a given coronary stenosis will cause myocardial ischaemia, and so to help clinicians decide the next step in a patient's care^[3].

A little background makes clear why that question matters. A coronary CT angiogram is a scan taken from outside the body that shows the coronary arteries and any narrowings in them. Flow reserve measures how much the blood flow through a vessel can rise when the heart muscle demands more. In invasive practice the answer is obtained by passing a catheter and a pressure wire into the coronary artery and measuring across the narrowing; the result is direct, but the patient goes through an invasive procedure with its discomfort and small risks. Software of this kind tries to derive a comparable answer from the images plus a model of blood flow, so that some patients can be assessed without the catheter procedure. The clinically important distinction is between a narrowing that merely looks tight and one that actually limits the blood supply.

Approvals in China

In April 2018 the product became the first of its kind admitted to the NMPA's special approval channel for innovative medical devices^[2]. The company passed GMP certification in June 2018, and the product obtained the EU CE mark that August^[2]. In January 2020 the software received a class III medical device registration certificate, which the company calls China's first for an AI device^[1][2]. In September 2020 it obtained a reimbursement code and began selling into hospitals^[2]. For medical software the reimbursement code matters as much as the certificate: without it, a hospital has no routine way to charge for the analysis.

Outside China

In April 2022 the software was cleared by the US FDA; the company describes it as the first product of its kind to hold Chinese, US and EU approvals^[2]. It obtained Singapore's HSA certification in December 2023, Hong Kong, China certification in April 2025 and Taiwan, China certification in June 2025^[2].

Use in hospitals

At Anzhen Hospital the technology had served 4,254 patients, with more than 1,000 cases avoiding invasive coronary angiography and about 20 million yuan saved for patients^[3]. By September 2022 the company had built more than 1,100 Shenmai AI diagnostic centres with large general hospitals^[3]. The company argues that the main benefit is sparing patients the pain and risk of invasive tests, not just the cost^[3].

Where it sits

Shenmai FFR went through the whole medical-device route rather than being sold as generic software: the innovative-device channel, then GMP, then a class III certificate, then a reimbursement code, then hospital sales. Its approvals outside China, and the joint diagnostic centres built with large hospitals, show how a product of this kind is actually deployed — as a service run together with hospitals rather than a program a clinic installs on its own. The Anzhen Hospital figures give one concrete sense of scale: several thousand patients analysed, and more than a thousand of them spared an invasive procedure.