Weekly Medical Device News [0622-0628]: Funding Surges, MicroPort's EU CE Milestone, NMPA Approvals, and Global Regulatory Updates

BEIJING—When AlphaStar Medical closed its angel round in March, the two-year-old vascular intervention startup wasn't just raising capital. It was betting that a team of materials scientists and 20-year industry veterans could crack a market long dominated by foreign players. The funding, backed by Taiyuan Pharmaceutical and Hangzhou Runmiao Fund, will bankroll animal trials and GMP facility construction—critical steps before clinical trials can begin.

AlphaStar is one of four Chinese medical device startups that secured funding this week, part of a broader wave of capital flowing into the sector as companies race to develop domestic alternatives to imported technologies and prepare for public listings.

Beijing Percutek Therapeutics, a national-level "little giant" enterprise specializing in vascular disease treatment, is taking a different path to the public markets. After terminating its STAR Market IPO application in 2022, the company has entered the review process for a Beijing Stock Exchange listing. The pivot comes as Percutek achieved profitability in 2024 and doubled its profits in 2025. The company plans to issue up to 24 million shares—27.6 million if the over-allotment option is fully exercised—with proceeds earmarked for a new high-end medical device production base, R&D center expansion, and working capital. Under BSE listing standards requiring a market cap of at least 1.5 billion yuan and combined R&D spending of 50 million yuan over two years, Percutek's research expenditures exceeded 100 million yuan in 2024 and 2025 combined.

In vascular intervention, Zhejiang Barty Medical Technology announced the completion of nearly 200 million yuan in financing led by Chuulifang Investment, with participation from Zhejiang Province's "4+1" biopharmaceutical and high-end medical device industry fund, Yifeng Capital, and continued backing from existing shareholder Junxingjian Capital. Qifeng Capital provided financing support. Founded in 2015, Barty specializes in vascular intervention technologies, with its flagship MatrixSuperPTX® peripheral constrained drug-coated balloon promoting a "intervention without implantation" minimally invasive treatment approach. The funds will support commercialization of this product, clinical evidence accumulation, construction of a next-generation intelligent production base, and development of subsequent vascular intervention innovations.

Hangzhou Nansu Technology, which has spent years developing digital therapeutics for neurological rehabilitation, is repositioning itself from a pediatric rehabilitation service provider to a full-lifecycle neurological rehabilitation technology platform. The company completed a Pre-B round of tens of millions of yuan led by Meihua Ventures, with Jiangxi Financial Holdings Group participating. The capital will fund development of its "time target" closed-loop brain-computer interface technology platform, clinical validation and regulatory submission for digital therapy-electrical stimulation combination products, and expansion of its industrial ecosystem and service network.

Remote Surgery Gets EU Stamp

MicroPort Robotics' Toumai® Remote system achieved European CE certification under the Medical Device Regulation, enabling multi-department robotic remote surgery across the EU. The certification, widely regarded as one of the world's most stringent medical device准入 standards, validates the safety and commercial viability of remote surgery. The Toumai® system, which has already secured approvals in nearly 20 countries, is now a commercially deployed remote surgery platform capable of "full-department, full-procedure" applications. MicroPort's achievement positions the company as a global "rule definer" in remote surgical technology.

NMPA Approvals Expand Treatment Options

China's National Medical Products Administration approved two significant devices this week. Fengkaili Medical Devices (Shanghai) received approval on June 18 for its interventional left ventricular assist device and catheter pump kit. The system, comprising control equipment, control leads, a mobile cart, a blood-pumping catheter, and perfusion tubing, provides left ventricular support for adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and stable hemodynamics undergoing high-risk percutaneous coronary intervention. The device uses an external motor design connected via a flexible drive shaft for short-term ventricular assistance.

Tianyi Medical (301097.SZ) announced on June 25 that it received NMPA approval for its single-use continuous renal replacement therapy tubing set. The Class III medical device, registered under number 国械注准20263101329 and valid until June 22, 2031, serves as a blood and fluid pathway during continuous renal replacement therapy. The product, compatible with Asahi Kasei's PlasautoΣ (Sigma) CRRT continuous blood purification equipment, expands Tianyi's consumable product line in the blood purification field and strengthens its positioning in critical care treatment solutions.

Strategic Partnerships and Regional Initiatives

China National Medical Devices Group and MicroPort Medical signed a strategic cooperation agreement focusing on coronary artery disease treatment. The parties held a symposium on coronary field collaboration, with China National Medical Devices deputy general manager Dang Tiefei expressing hopes to deepen cooperation to benefit more patients, while MicroPort president Yue Bin pledged full commitment to the partnership. The agreement marks a new phase in strategic collaboration, with China National Medical Devices' strategic product operations center accelerating nationwide deployment of strategic products to promote domestic substitution in the medical field.

Yaxiaoda Medical City and GE Healthcare are exploring opportunities to integrate advanced diagnostic technologies and digital health solutions for AI-driven critical care services. The proposed collaboration aims to strengthen clinical decision-making, improve patient monitoring, and enhance treatment outcomes in intensive care environments. The partnership reflects the growing application of AI and remote monitoring technologies in healthcare, with AI-powered command centers increasingly supporting critical care teams through continuous patient monitoring, predictive analytics, and early warning alerts to identify risks before clinical deterioration becomes life-threatening.

Jinan, capital of Shandong Province, outlined next steps for its National Health and Medical Big Data Northern Center. The city has aggregated massive data resources, launched ten application scenarios, completed its first compliant data transaction, and formed an initial batch of high-quality datasets. Future plans include upgrading the Northern Center to a national-level center, optimizing computing power layout and storage capacity, and establishing a national AI application pilot base for "AI + medical and health care." Key focus areas include medical large language models, brain-computer interfaces, and rehabilitation robots.

Guangdong Province is preparing to roll out a series of special policies to promote deep integration of AI technology in the medical device industry. The province has formed multiple industrial clusters in Guangzhou Huangpu, Shenzhen Pingshan, and Guangming districts, and established a leading group for AI and robotics innovation development along with a biopharmaceutical industry quality development task force. Guangdong will accelerate release of action plans for high-quality medical device industry development and "AI + pharmaceutical and medical device" application promotion schemes. The province is also launching a high-quality medical dataset construction initiative, supporting relevant institutions to build medical health big data platforms, unify data standards, and promote province-wide medical data interconnection to establish a data foundation for long-term industry development.

Shanxi Province is strengthening supervision of medical device distribution and usage across the province. The provincial drug administration held a medical device risk assessment meeting, identifying current risks in distribution and usage环节 and deploying next-phase work. Local authorities are tasked with focusing on key areas including centralized procurement selection and adolescent myopia prevention, establishing risk ledgers to ensure closed-loop risk management. The administration will strengthen supervision and inspection, crack down on illegal activities such as unlicensed operations, and expose typical cases as deterrents. The initiative also emphasizes implementing territorial supervision responsibilities and enterprise principal responsibilities, building a collaborative supervision framework, and enhancing grassroots supervision personnel's business training to improve risk detection and response capabilities.

International Regulatory Updates

The U.S. Food and Drug Administration announced the reclassification of numerous medical devices to Class II (special controls). Affected devices include external lower limb nerve stimulators for treating restless leg syndrome, computerized behavioral therapy devices for fibromyalgia symptoms, SARS-CoV-2 serology tests, infant supine sleep systems, foam or gel chemical sterilants/high-level disinfectants, breast implant aspiration removal systems, and prognostic tests for diagnosing preeclampsia occurrence or progression.

Australia's Therapeutic Goods Administration is counting down to mandatory implementation of the first phase of its Unique Device Identification system. Starting July 1, 2026, all Class III and Class IIb medical devices circulating in the Australian market must complete UDI labeling and submit data to the Australian UDI Database (AusUDID). Non-compliance risks product delisting and Australian Register of Therapeutic Goods registration invalidation.

This weekly briefing is compiled from online news reports.