Global First! "1 Innovative Medical Device" Approved for Market Launch

Recently, the National Medical Products Administration approved the innovative product registration application for the "Coronary Interventional Surgery Control System" by Beijing Vimait Medical Technology Co., Ltd. (hereinafter referred to as: Vimait Medical).

Image source: NMPA official website

01

first realization

three major system data closed loop

Weimai Medical was founded in 2014 and is a leading provider of interventional diagnostic and therapeutic equipment and solutions in China, focusing on the field of interventional diagnostic and therapeutic equipment and providing full-process solutions. Its product pipeline covers multiple product lines including medical angiographic X-ray machines (DSA), mobile C-arm X-ray machines, interventional surgical robots, and intelligent image processing platforms, and it is at the forefront of research and development in the field of interventional surgical robots globally.

The ETcath® interventional surgery auxiliary system approved for market launch this time is the world's first interventional surgical robot to achieve a "eye-hand-brain" trinity, consisting of a control cabinet, LCD display, touchscreen, control box, and wire and catheter actuation mechanism. It is suitable for the delivery and manipulation of catheters and guidewires during percutaneous coronary intervention. According to the NMPA official website, this product belongs to the stent delivery type of robots, adopting a compartment-controlled interventional robotic surgical system, biomimetic-based guidewire control technology, and flexible guidewire resistance detection technology.

Image source: NMPA official website

It is worth mentioning that the product has for the first time achieved a closed loop of data for the "eye-hand-brain" three major systems, leading a revolution in interventional surgery:

• Eye - DSA high-definition noise-free imaging: Its multimodal image fusion technology can real-time overlay DSA/CT/MRI 3D vascular models, and AI intelligent marking can automatically identify lesions with 0.1mm precision, which is 5 times more accurate than the naked eye;
• Hand—image guided precise and safe operation: sub-millimeter motion control allows for errors less than 0.05mm, its tactile sensing system has a minimum force perception accuracy of 0.01N, and it is compatible with a wide range of consumables.
• Brain-AI Intelligent Image Analysis Platform: The platform boasts a database of millions of cases, second-level model generation, and precise image data analysis.

"Eye-hand-brain" three major systems integration also has huge potential advantages, providing the operator with a fully integrated immersive surgical robot operation space; and high-definition images, precise hands, and a fully autonomous decision-making brain system, which connects the underlying data, strong real-time, and highly collaborative intelligent systems; in addition, it also constructs an artificial intelligence reinforcement learning platform based on image data + operator behavior, moving towards a more advanced intelligent operating system.

ETcath® interventional surgery auxiliary system is a potential blockbuster product that Vimedix Medical has been refining for ten years. The emergence of this product marks the transition of our country's interventional surgeries from the "manual era" to the "intelligent era."

02

multiple products launched

enter the domestic high-end equipment market

In addition to the ETcath® interventional surgery auxiliary system, WeMed has multiple potential products that are accelerating the domestic substitution process in this field. According to the YZ Medical Device Data - China's Listed Device Screening System, apart from the product launched this time, WeMed has 7 other products approved for market release.

Image source: Yaozhi Medical Device Data - China Marketed Device Screening System

Medical angiographic X-ray machine and Precision software are both major products that WeMed Medical has been refining over a decade from 2015 to 2025.

Among them, Weimai Medical's medical angiography X-ray machine Aurora DSA - Pilot3000 is a high-end all-purpose medical angiography X-ray machine and is the first domestically produced high-end DSA to have both NMPA and EU CE dual certification. It has successfully broken the monopoly of international brands, overcome key technology "choke point" issues, and filled the gap in the domestic high-end DSA market.

It is understood that the angiographic X-ray machine (DSA) is typically composed of an X-ray generating device, a digital image receiving device, image information analysis, display system, and catheter bed. It is mainly used for observing vascular lesions and positioning measurements of vascular stenosis, featuring clear images and high resolution, and is hailed as the "gold standard" for diagnosing cerebrovascular diseases.

However, at present, the DSA market in our country has long been dominated by foreign brands, with GE Healthcare, Philips, and Siemens Healthcare being the main players in this product field. Nevertheless, with the development of technology, a number of local innovative medical device companies have emerged in this sector, such as Neusoft Medical, United Imaging Healthcare, Wandong Medical, and more. An increasing number of medical device companies are beginning to tackle the high-end market, and products have already been launched.

According to the data, in 2024, the top four brands in China's DSA market are Philips, Siemens Healthineers, GE Healthcare, and Neusoft Medical. Among them, Philips' market share increased by 4.76%; United Imaging Healthcare increased by 3.19 percentage points year-on-year, entering the top five. The market concentration of the top four brands (CR4) reached about 93%, and the market competition remains very intense.

However, with the implementation of the centralized procurement policy, it brings opportunities for China's DSA equipment companies. In terms of average unit price, among the main DSA brands and models in China, United Imaging Healthcare's uAngio 960 is the only DSA with an average unit price exceeding 10 million yuan. Following that, Siemens Healthineers' Artis Q ceiling, Philips' Azurion 7 M20, and GE Healthcare's Optima IGS Ultra all have average unit prices exceeding 8 million yuan. The lowest average unit price is for the domestic brand Neusoft Medical's NeuAngio 30C, with an average unit price of just 5.43 million yuan, further promoting the process of domestic substitution.

03

concluding remarks

With the support of policies and the promotion of continuous technological development, the "gold content" of domestic medical devices is becoming higher and higher, and local medical devices are continuously shining with new brilliance.

1. "2024 China Angiography X-ray Machine (DSA) Market Insights" MedEquip DataWin
2. Weimai Medical Official WeChat