Linear Capital Portfolio Company | Boyi Huixin Secures China's First NMPA Class III Approval for Vascular Interventional Surgery Planning Software!

On November 1, 2023, DetecMicro® — a vascular interventional surgical planning software developed by Linear Capital portfolio company Baiyi Huixin (Hangzhou) Network Technology Co., Ltd. ("Baiyi Huixin") — received official approval from China's National Medical Products Administration (NMPA) for domestic Class III medical device registration (Registration No.: Guo Xie Zhu Zhun 20233211596). DetecMicro® holds independent intellectual property rights and fills a domestic gap in this field.

Zeren Bai, Investment Vice President at Linear Capital, commented: "Congratulations to Baiyi Huixin on securing China's first NMPA Class III certificate for vascular interventional surgical planning software. The cardiovascular and cerebrovascular digital-assisted diagnosis and treatment space that Baiyi Huixin operates in represents a classic multidisciplinary intersection — spanning computer graphics, mechanical simulation, AI, and clinical medicine. First, achieving a hospital-ready product required enormous technical breakthroughs. Second, obtaining the first domestic certification in this field presented exceptionally high regulatory hurdles. This approval validates the team's comprehensive capabilities, and we believe Baiyi Huixin will continue to deepen its work in cardiovascular and cerebrovascular diseases, creating even greater value."

The detailed report follows:

(NMPA Medical Device Approval Certificate)

01 In Lockstep

Precision Coordination of Efficiency and Quality

As medical standards continue to advance, clinical treatment approaches have gradually shifted from traditional highly invasive procedures toward minimally invasive techniques — particularly prominent in cardiovascular and cerebrovascular disease treatment. However, the rapid development of various innovative treatment technologies has been accompanied by inadequate tools and inconsistent understanding, leading to a lack of standardization in disease diagnosis and treatment and unstable quality control.

How to ensure standardized diagnosis and treatment of cardiovascular and cerebrovascular diseases has become an industry-wide priority, with the absence of industry norms and evaluation tools serving as a critical bottleneck. Encouraged and supported by numerous frontline clinical experts, Baiyi Huixin has continuously challenged the bottlenecks of technical and knowledge cross-boundary integration, achieving China's first surgical planning software that combines structural analysis and treatment selection.

The software employs mature and reliable graphics and image algorithms. Based on patient imaging data, it performs refined reconstruction of vascular structures, providing morphological parameters such as dimensions and angles — offering clinicians important reference basis for surgical planning and improved diagnostic decision-making.

Compared to traditional two-dimensional measurement, DetecMicro® enables automated three-dimensional measurement, not only saving clinicians substantial measurement time but also generating personalized treatment recommendations tailored to each patient's lesion characteristics.

(DetecMicro® User Interface)

After importing imaging data, the software can automatically generate a 3D vascular model within 20 seconds and complete corresponding procedural template measurements within 1 minute. It provides over 20 fundamental preoperative planning parameters and generates visualized graphical reports, satisfying the majority of clinical preoperative planning and postoperative follow-up scenarios. Additionally, DetecMicro®'s intelligent workflow assistant standardizes the preoperative planning process, enhances ease of use, significantly reduces the physician learning curve, and improves both efficiency and quality.

02 Deep Application

Comprehensive Coverage of Scenario Details

In recent years, many complex and challenging cases previously treated primarily with open surgery — such as aortic dissections or aneurysms involving the ascending aorta and aortic arch, or juxtarenal and pararenal abdominal aortic aneurysms involving important visceral arterial branches — have gradually become treatable through entirely endovascular techniques using preoperative pre-fenestration, intraoperative in-situ fenestrated stents, and branch stent grafts based on available technologies[1].

DetecMicro®'s branch positioning function can simulate preoperative planning scenarios for fenestrated procedures, intelligently identifying whether stent dimensions are suitable for selected vascular segments, and automatically outputting key parameters for branch vessels such as optimal fenestration angles and relative positional relationships between fenestrated vessels.

Furthermore, the software's unique perspective view and virtual endoscopy auxiliary functions more accurately display dissection tear locations and intraluminal vascular conditions, providing physicians with more comprehensive lesion site information. These capabilities hold significant importance in complex procedures, assisting physicians in more thoroughly evaluating surgical risks, formulating corresponding surgical plans, helping improve surgical precision and safety, reducing intraoperative complications, and providing better assurance for patient treatment outcomes.

Beyond this, DetecMicro® also allows users to manually adjust based on their understanding or creativity atop its automated functions, extending application scenarios according to personalized needs. Going forward, Baiyi Huixin will continue to deepen its focus in cardiovascular and cerebrovascular diseases while expanding toward additional clinical application scenarios. With patient needs as its goal and physician needs as its guide, the company will continuously introduce innovative, scientific clinical applications and research tools, serving medical quality control, precision diagnosis and treatment, and research innovation.

About Baiyi Huixin

Baiyi Huixin (Hangzhou) Network Technology Co., Ltd. is a technology provider focused on integrating engineering simulation technology with clinical medicine. The company possesses core technical reserves and independent intellectual property rights, pioneering novel non-invasive evaluation methods for in vivo tissue.

Our mission stands at the forefront of the healthcare industry's digital transformation, delivering precision medicine to the broader population through solid, leading foundational technology. We provide reliable multidimensional support to medical innovation device R&D institutions, building medical quantitative indicator system tools and platforms, creating standardized new medical tools, and powering efficient healthcare.