Stop following, start defining! The "DeepSeek Moment" of advanced medical devices in China

For a long time, in the global innovation landscape of advanced medical devices, Chinese enterprises have mostly played the role of "followers" - introducing and digesting technologies, imitating and iterating products, and optimizing costs. Especially in cutting - edge fields such as cardiovascular, neurointervention, and tumor treatment, core technologies and product innovations have mostly been monopolized by multinational giants.

However, this pattern is quietly changing. On the one hand, with the in - depth implementation of the national innovation - driven development strategy and the continuous investment of the capital market in medical hard technology, the innovation environment in China has become more fertile. On the other hand, as the cooperation system between clinicians and engineers matures, a group of Chinese medical device enterprises with a global vision have begun to target the "uncharted territory" and achieve original innovation from scratch in niche fields.

The field of pulmonary hypertension (PH) treatment is such a "tough nut" that was firmly controlled by international giants, and the survival situation of patients was extremely pessimistic.

Now, a Chinese medical device enterprise named Pamu Medical, with its original pulmonary artery denervation (PADN) technology, not only successfully obtained the EU CE - MDR certification for its supporting products in March 2025 and entered the European market, but also recently received good news - two global multi - center clinical studies approved by the FDA simultaneously, which has become a milestone for Chinese advanced medical devices going global.

From following in the past to leading now, Chinese original medical innovation has stepped into the global spotlight.

Breaking the ice with two IDE approvals from the FDA: Chinese medical devices enter the world's highest regulatory system

Pulmonary arterial hypertension (PAH) is a malignant cardiovascular disease, which is even called "the cancer of the cardiovascular system" in clinical practice.

In the past, the mainstream treatment options in this field mainly relied on targeted drugs developed by multinational pharmaceutical companies. Although these drugs could delay the progression of the disease to some extent, there were still pain points such as limited efficacy, high prices, and the need for lifelong medication. Could interventional methods fundamentally change the pathophysiological mechanism of the disease? Pamu Medical chose this less - traveled path - the original pulmonary artery denervation (PADN technology).

Specifically, PADN is an interventional treatment based on a catheter platform. It blocks the excessive excitation of the sympathetic nerves around the pulmonary artery through high - frequency ablation, thereby reducing pulmonary artery pressure, improving cardiac function, and enhancing exercise tolerance.

This technology, independently developed in China with complete independent intellectual property rights, has recently obtained two Investigational Device Exemptions (IDE) from the US FDA: one is a clinical trial for Type I pulmonary arterial hypertension (PAH) under the Humanitarian Device Exemption (HDE) pathway; the other is an IDE clinical trial for Type II pulmonary hypertension (related to left - heart diseases, such as pulmonary hypertension secondary to heart failure).

This is a historic breakthrough as the first Asian case to obtain two IDE approvals from the FDA. It not only symbolizes that China's original PADN technology has officially entered the regulated clinical research system in the United States, but also means that this therapy will enter the "highest hall" of global evidence - based research and face authoritative review and verification.

What's more notable is that Pamu Medical has also obtained full coverage approval from the US Centers for Medicare & Medicaid Services (CMS). First, during the clinical trial phase, doctors can receive reasonable reimbursement, ensuring that the PADN surgery can smoothly enter actual clinical applications; second, after the product is approved for marketing in the future, relevant costs will be fully covered, providing affordable treatment options for patients.

Behind this, there are three significant meanings: Clinically, it ensures the smooth connection between PADN research and application; in the market, it means that once the product is approved, it will have natural advantages in terms of price and accessibility; from a global academic perspective, it demonstrates that China's original technology is not just about "entering" but also about "standing firm" and gradually participating in shaping new clinical standards.

From an industry perspective, this is a rare event in the history of Chinese medical devices, where a First - in - Class original technology bravely challenges the FDA. It is also a vivid manifestation of the "Deepseek Moment" in 2025 in the field of advanced medical devices.

Chinese innovation goes global: How did PADN gradually win international trust?

Throughout the global industrial development history, original innovation is a difficult and arduous task, but it is also the right thing to do.

Similarly, the internationalization of PADN technology is not achieved overnight. It is a systematic, phased process of building scientific and clinical consensus. This can be seen from the development path of Pamu Medical - it reveals a clear strategic layout of "Chinese R & D, global verification".

It is understood that Pamu Medical's exploration of PADN can be traced back to 12 years ago. From animal experiments and human studies to a series of clinical studies such as PADN - 1 and PADN - 5 and long - term follow - ups, the safety and effectiveness data have been gradually consolidated.

In 2018, PADN was included in the "Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension", and the registration clinical study for China's NMPA was launched in the same year.

In 2022, its key clinical results were published in JACC: Cardiovascular Interventions, attracting wide attention from the international academic community.

In August 2022, the European Society of Cardiology (ESC) included PADN in its "Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension" for the first time, indicating that the technology had initially gained international authoritative academic recognition.

In March 2025, PADN successfully obtained the EU CE - MDR certification, becoming the first Chinese cardiovascular interventional device to obtain the CE certification based on pure domestic clinical data and be exempted from European clinical trials, breaking the previous shackles that Chinese devices had to repeat overseas clinical trials when going global.

In June 2025, the first batch of three overseas commercial surgeries were completed at Al Qassimi Hospital in Sharjah, UAE, igniting the first spark in the international market.

It is not difficult to find that in addition to the two IDE approvals from the FDA, PADN has also continuously achieved breakthroughs in the European and Middle Eastern markets. This not only marks the beginning of commercialization but also an important step for Chinese original technology to enter global clinical practice.

If the two IDE approvals from the FDA are the "passport" to the international market, then academic discourse power is the "commanding height" for future competition.

To promote the global clinical development and standard establishment of PADN technology, Pamu Medical took the lead in establishing an International Steering Committee composed of top cardiovascular experts from North America, Europe, and Asia, covering authorities in fields such as pulmonary hypertension, heart failure, and interventional cardiology. This committee not only guides the design of global multi - center clinical trials but also is committed to promoting PADN to be included in more international guidelines, winning discourse power from the scientific mechanism level.

It should be noted that in the past, the academic rules in the field of pulmonary hypertension were mostly dominated by European and American institutions; now, with the rise of PADN, China is not only a participant but also an initiator of topics and a shaper of rules. This is not only a technological leap but also a reconstruction of medical discourse power.

It can be seen that PADN's entry into the US market is not due to a single - point breakthrough but is strongly supported by a complete set of innovation systems from basic R & D, clinical evidence - based research, regulatory registration to academic consensus.

Continuous capital support brings greater imagination to Chinese advanced medical devices

Pamu Medical's R & D and internationalization process have continuously won high recognition and multiple rounds of support from professional capital. Looking at the timeline:

In August 2021, it completed a Series A financing of tens of millions of dollars (led by OrbiMed and Qianji Capital, with participation from Lilly Asia Ventures and GaoRong Capital);

In October 2022, it completed a Series B financing of tens of millions of dollars (led by Yuansheng Venture Capital, with participation from OrbiMed, Qianji Capital, etc.);

In March 2025, it completed a Series C financing of nearly 100 million dollars (led by Qiming Venture Partners and Lilly Asia Ventures, with additional investment from OrbiMed and GaoRong Capital);

In May 2025, it received an additional financing of tens of millions of dollars from European private equity firm EQT and Qiming Venture Partners.

Behind the consecutive rounds of financing is the firm recognition of its technology, clinical practice, and going - global strategy by a group of investment institutions that focus on long - termism and understand hard technology.

It can be said that Pamu Medical's internationalization breakthrough in PADN technology is a microcosm of the Chinese medical device industry's transformation from imitation - based innovation to original innovation and from the domestic market to the global market.

More importantly, after the significant breakthroughs made by original innovation enterprises represented by Pamu Medical, the investment logic of the capital market in the Chinese medical device sector is undergoing a profound transformation: from focusing on domestic substitution, cost advantages, and policy dividends in the past to gradually paying attention to real original innovation, global clinical value, and the ability to participate in international rules.

This means that more and more investment institutions are willing to support enterprises that target the gaps in international clinical needs, conduct global multi - center trials, and challenge the regulatory high - ground of the FDA/CE with a longer - term perspective and greater courage, thus bringing greater imagination to the industry.

It can be seen that the exploration of a group of pioneer enterprises represented by Pamu Medical has undoubtedly injected a shot in the arm into the industry: only by adhering to long - termism, abiding by scientific evidence - based research, and understanding global rules can we achieve a leap from following to leading in this global competition centered on technological innovation and measured by clinical value.