In November 2025, the National Medical Products Administration launched an expedited review pathway for innovative medical devices, resulting in the rapid approval of numerous high-end devices focused on interventional therapy and imaging-assisted diagnostics. These products leverage precise technological breakthroughs to address critical clinical challenges, spanning key therapeutic areas such as cardiovascular disease, oncology, and vascular surgery. They not only underscore China’s robust innovation capacity in the medical device sector but also provide patients with higher-quality diagnostic and treatment options.

Cardiovascular Intervention: Dual Breakthroughs in Precision Control and Safe Treatment

1. Single-use pressure-monitoring cardiac pulse-field ablation catheter

On November 20, this catheter developed by Shanghai MicroPort Electrophysiology Medical Technology Co., Ltd. was officially approved for market launch. As China’s first pressure-monitoring pulsed ablation catheter equipped with saline irrigation, it integrates multiple core technologies, bringing a revolutionary advance to the treatment of arrhythmias. The underlying principle is the delivery of high-intensity, short-pulse-width pulsed electric fields that induce irreversible electroporation of the cell membrane in diseased tissue, ultimately triggering apoptosis. This non-thermal ablation approach effectively reduces the risk of tissue damage associated with conventional thermal ablation.

Even more noteworthy is its innovative configuration: a pressure sensor based on the strain-gauge principle enables real-time measurement of the contact pressure between the catheter tip and the cardiac wall. Combined with magnetic-field–based positioning and a three-dimensional cardiac electrophysiological mapping system, this allows physicians to precisely visualize the catheter’s location and apposition within the heart. Meanwhile, the saline irrigation feature ensures more uniform and stable energy delivery, thereby minimizing the risk of complications arising from localized excessive energy deposition. For patients with atrioventricular nodal reentrant tachycardia and atrioventricular reentrant tachycardia, this catheter transforms ablation procedures from being “experience-driven” to “precisely controllable,” significantly enhancing both procedural safety and treatment efficacy stability.

2. Cardiac Electrophysiology Interventional Surgery Control System “TITIAN”

This system, approved in November, was independently developed by Shaoxing Mayo Cardiac Magnetic Medical Technology Co., Ltd. It is China’s first pressure-sensing atrial fibrillation ablation robot to receive approval through the innovative medical device green channel. Its core advantage lies in equipping physicians with “mechanical fingers that extend into the cardiac chamber”—a pair of remotely controlled robotic arms that can precisely replicate expert surgical techniques, thereby overcoming the limitations of human hand tremor and enabling precise positioning of the ablation catheter under the guidance of a three-dimensional mapping system.

During the procedure, the system provides real-time visualization of the contact pressure between the catheter and the myocardial tissue—capable of detecting even subtle changes ranging from 1 to 10 grams—which is a critical determinant of the success or failure of atrial fibrillation ablation. For patients, robot-assisted minimally invasive surgery can reduce hospital stays to 1–2 days, minimizing trauma and accelerating recovery; for physicians, it not only lowers radiation exposure during fluoroscopic guidance but also shortens the learning curve for performing such complex procedures from six months to one year down to just a few weeks, thereby enabling grassroots hospitals to routinely perform high-difficulty surgeries in a standardized manner.

Vascular Surgery: A Dedicated Endovascular Solution for Complex Aortic Diseases

On November 6, the G-Branch™ thoracoabdominal covered stent system, jointly developed by Professor Guo Wei’s team at the PLA General Hospital and MicroPort Medical (Group), was approved for market launch. This device is specifically designed to treat thoracoabdominal aortic aneurysm (TAAA), a complex and high-risk condition. As the largest arterial trunk in the human body, the thoracoabdominal aorta has a highly intricate anatomy, and lesions often involve multiple branch vessels. Traditional open surgical repair is highly invasive and carries substantial risks, making it difficult for many elderly patients or those with compromised cardiopulmonary function to tolerate.

This stent system features a modular design, comprising multiple components such as the main stent, peripheral stents, and extension stents. These can be intraoperatively combined to precisely match the patient’s unique anatomical characteristics, including vessel diameter and curvature, thereby achieving optimal adaptation to the highly variable morphology of lesions. The stringent requirements for the stent’s anchoring-zone parameters promote more standardized preoperative assessment, effectively reducing the risk of serious postoperative complications such as endoleaks, stent migration, and branch-vascular occlusion. Clinically, this system not only provides therapeutic options for patients who are ineligible for open surgical repair but also facilitates the widespread adoption of minimally invasive techniques for treating complex aortic diseases in China, marking the transition of aortic disease diagnosis and treatment in our country into an era of precision medicine.

Medical Imaging: AI Facilitates Early Diagnosis and Treatment of Prostate Cancer

On November 5, the prostate cancer magnetic resonance imaging–assisted detection software developed by Shanghai Siemens Medical Devices Co., Ltd. was approved. By deeply integrating artificial intelligence with medical imaging, this software precisely addresses the clinical challenges in diagnosing prostate cancer. In China, the incidence of prostate cancer has been rising year by year; moreover, due to its insidious onset, most patients are already in the intermediate or advanced stages at initial diagnosis. Traditional diagnostic methods, meanwhile, suffer from low image-reading efficiency, reliance on clinician experience for lesion identification, and a shortage of skilled personnel.

This software is built on deep-learning technology and rigorously adheres to the PI-RADS diagnostic criteria, automatically performing three core tasks: precise segmentation of the prostatic gland, automated identification and segmentation of lesion areas, and quantitative scoring of lesion malignancy. Following joint validation across multiple hospitals, including Shanghai Changhai Hospital, its accuracy in analyzing MRI images has reached the level of expert radiologists, enabling rapid detection of subtle, occult lesions. Clinically, it not only enhances image-reading efficiency and diagnostic consistency but also makes early screening and diagnosis of prostate cancer feasible, thereby securing the optimal timing for treatment, significantly improving survival rates, and enhancing patients’ quality of life.

Therapeutic Monitoring: Real-Time Imaging Empowers Precise Treatment Management

The semiconductor laser therapeutic device with magnetic resonance monitoring, approved in October and November, has achieved a breakthrough in integrating “treatment” and “monitoring.” At its core, this approach combines laser therapy with magnetic resonance imaging: as the laser targets the diseased tissue, the MRI system simultaneously generates high-resolution, real-time images, enabling clinicians to directly visualize changes in lesion size, tissue temperature distribution, and the extent of treatment. This real-time monitoring capability addresses the longstanding challenges of conventional laser therapy—namely, the difficulty of precisely controlling the treatment dose and the inability to promptly assess therapeutic efficacy. Whether for tumor ablation or soft-tissue treatment, it enables precise targeting of the lesion while minimizing damage to surrounding healthy tissue, thereby enhancing both the scientific rigor and safety of laser therapy.

High-Fidelity Models: The Critical Bridge Between Laboratory Research and Clinical Translation of Innovative Medical Devices

The successful approval of these high-end medical devices would not have been possible without rigorous testing and validation throughout the R&D process. Xian Dewei Medical, a supplier specializing in high-end medical testing equipment, has established a “clinical-grade” validation platform for device R&D by leveraging its highly realistic simulation models, providing core support across multiple dimensions.

1. 1:1 anatomical replication to ensure test authenticity.

DeWei Medical’s simulation models are built on extensive clinical data derived from real patient CT and MRI scans, encompassing diverse population characteristics. Using advanced 3D reconstruction techniques, these 2D images are transformed into high-fidelity 3D digital models, which are then fabricated into physical prototypes via high-precision 3D printing. Taking the coronary artery model as an example, every anatomical detail—from the diameter and wall thickness of the main vessel to the angulation of its branches, and even the precise location and morphology of stenotic plaques—is fully consistent with human anatomy. This level of accurate replication ensures that test scenarios—such as the advancement trajectory of ablation catheters and the deployment position of stents—are highly aligned with clinical reality, thereby providing a foundation of “anatomical accuracy” for device testing.

2. In-house developed materials match the characteristics of real devices, accurately replicating clinical operational feedback.

The model is fabricated using a proprietary, highly transparent soft silicone and gel material that has undergone hundreds of formulation optimizations, resulting in mechanical properties—such as elastic modulus and tensile strength—that are fully consistent with those of real blood vessels and cardiac tissue. When the stent under test is deployed within the model vessel, it exhibits the same elastic deformation resistance as human vasculature; moreover, the “tactile feedback” experienced when the ablation catheter contacts the model tissue closely mimics the tactile sensation of true myocardial apposition. In addition, the material’s high transparency enables researchers to clearly visualize the instrument’s trajectory and the energy-delivery process, providing intuitive evidence for performance optimization.

3. Authoritative certification + scenario simulation to meet end-to-end testing requirements.

All models have undergone biomechanical and functional testing by independent, authoritative third-party institutions, and the resulting official reports serve as critical supporting documentation for device registration submissions. To meet diverse device requirements, Dewei Medical also offers customized pathological modules, such as coronary artery calcified plaques and aortic dissection models. In addition, our integrated blood-flow simulation platform enables precise control of pressure, flow rate, and pulsation frequency, accurately replicating in vivo human hemodynamic conditions and facilitating complex tests such as in-stent thrombosis modeling and catheter pressure-response analysis.

From cardiovascular intervention to medical imaging diagnostics, the rapid launch of these innovative devices has clearly outlined the trajectory of China’s healthcare technology upgrade. Meanwhile, DeWei Medical’s highly realistic simulation models serve as invisible “quality inspectors” and “accelerators,” leveraging technological innovation to empower medical device R&D, facilitate the transition of more high-end medical devices from the laboratory to clinical practice, and inject sustained momentum into the high-quality development of the healthcare industry.