Time flies, 2025 has passed, and 2026 has arrived. Looking back at the past year, the medical device industry has begun to transform from quantitative change to qualitative change. This year, for the first time, a Chinese company...Innovative Products (Xi'an Dami Group Co., Ltd.TaiChiPro) Selected for the "Nobel Prize" of the global medical device industry ---Prix Galien. This is since 2007,The first Chinese medical device product was selected for the Prix Galien USA, marking the initial recognition of Chinese innovation by American peers.BesidesPrix GalienIn addition, the NMPA approved 76 innovative medical device products this year. Several of these products are the first domestic breakthroughs, such asCore Medical Heart Intervention Pump, Huihe'sTranscatheter Tricuspid Annuloplasty System,Vivasure Medical's Reflux TAVREtc.It is these groundbreaking innovative products that have also gradually improved the financing of China's medical device industry (for high-quality companies), with multiple companies completing financings of over 100 million US dollars (including Pam, which adheres to original innovation). These top-tier enterprises lay the foundation for the rise of China's medical device industry.Moreover, after the frenzy before and after the pandemic in China, the market began to gradually return to rationality. MicroPort started to integrate its subsidiaries (no longer pursuing spin-offs for listing).Ying Tai Acquires High-Quality Assets at Low Prices (Vivasure Medical), which undoubtedly marks the transformation of China's medical device market (by strengthening enterprises through resource reorganization).As the medical device industry in China undergoes a qualitative transformation, domestically produced medical devices are about to truly take off. However, at present, there is still a gap between medical device innovation in China and overseas. The people in China's medical device industry need to continue working hard to achieve an overtaking, just as has been done in the automotive industry.The following are ten products selected by MedTFInnovative Medical Products (Selection Criteria: Must Be Products Approved for Market This Year)From Edwards, Pioneering Transseptal Mitral Valve ReplacementSAPIEN M3It is an innovative transcatheter mitral valve replacement product, which mainly consists of a fixed base andSAPIEN M3 Valve Composition.
The design of the fixed base can surround the patient's native mitral valve structure, providing a stable anchoring point for the subsequent implantation of the SAPIEN M3 valve.
SAPIEN M3 Valve is an improved version based on the well-established SAPIEN 3 Valve platform, specifically optimized for the mitral valve anatomical position.
SAPIEN M3The surgery is performed in two steps: first, the fixed base is implanted, followed by the implantation of the valve to complete the entire mitral valve replacement. The fixed base surrounds the native mitral valve leaflets, pulling them and the chordae tendineae towards the center of the base, which causes the papillary muscles to converge, creating a stable and consistent landing zone for the SAPIEN M3 valve. Both the base and the valve are delivered through a 29F outer diameter steerable sheath that is inserted percutaneously via the femoral vein.
【02】PerQseal Elite
SourceVivasure Medical，Absorbable Large-Caliber Vascular Closure Device
PerQseal EliteBased on Vivasure's PerQseal technology platform, it is specifically designed for large-bore vascular closure after cardiovascular interventional procedures such as TAVR and EVAR, providing an innovative solution that requires no suturing and is fully absorbable. InPerQseal EliteBefore listing, the current marketThere are no other fully bioabsorbable large-bore closure devices available. Moreover, unlike existing vascular closure devices, PerQseal Elite requires no preoperative preparation steps, further streamlining the surgical process.
PerQseal Elite adopts an intravascular implantation method, which is simpler and more controllable compared to traditional closure techniques. By avoiding the retention of foreign objects such as collagen, metal implants, or sutures, it allows the blood vessel to return to its natural state.
【03】WiSE CRT
Originated fromEBR Systems, Leadless Heart Failure Pacemaker
WiSE CRTIs aOvercomeLimitations of conventional CRT, and it is the only leadless ventricular pacing (LVEP) device. It uses wireless technology to deliver pacing stimuli directly to the interior of the heart's left ventricle. This method aims to overcome the limitations of traditional CRT, as pacing from the inside of the left ventricle is considered more physiological.。MeanwhileWiSE CRTThe design allows for more flexible selection of pacing sites, enabling customized treatment for patients.。WiSE CRTThrough a brand-new delivery system, the electrode is implanted.InLeft bundle branch area, plays a roleLeft Bundle Branch AreaPacing (LBBAP).WiSE CRTThe electrode onlyYesOne tabletRiceSize (diameter only 2.8mm).Thereby completely eliminating the necessity of installing pacing leads on the outer side of the left ventricle in traditional CRT and related complications.【04】Bendit17
Originated fromBendit Technologies, the world's smallest steerable microcatheterBENDIT17It is a new type of microcatheter that adopts a unique snake-bone design, which allows it to pass through various narrow sections and curved blood vessels. It can be used for both diagnosis and treatment, enabling the injection of diagnostic and therapeutic agents or drugs through distal and curved conduits during procedures.
Bendit17Brings a new level of maneuverability and precision to clinicians, enabling controlled navigation through complex anatomical structures while maintaining stability, control, and ease of use. Its unique features are designed to support clinicians in a variety of complex vascular procedures.
【05】Valvosoft
Originated fromCardiawave，Aortic StenosisNon-invasive therapyValvosoftIt is a non-invasive, real-time image-guided medical device,Non-invasiveHuman BodyTreatment of Aortic Stenosis. It is a fusion of multiple technologies --- including therapeutic ultrasound, robotics, and ultrasound imaging technology.ValvosoftThe core technology adopts advanced ultrasonic technology, namely Pulsed Cavitation Ultrasound Therapy (PCUT).。ValvosoftCan deliver high-intensity focused ultrasound, precise to the millimeter level, with mechanical energy (bubble cavitation, no heat generation), softening the calcified aortic valve leaflet tissue (even causing surface calcification to fragment), restoring its mobility, allowing the aortic valve to immediately reopen during treatment with a larger opening.【06】Vanquish
Originated fromFrancis Medical，Prostate Cancer Thermal Vapor AblationVanquishIt is a transurethral outpatient procedure designed to ablate targeted prostate tissue using thermal energy stored in sterile water vapor.VanquishAnd MicroPortrezūm adopts the same technology.
VanquishVery different from traditional thermal ablation technology. When injected under pressure, the steam passes through the intercellular spaces (convection) within seconds. The energy is evenly distributed throughout the evaporation area and uniformly ablates as the steam condenses back into water. This allows for better temperature control and helps avoid adverse events.
【07】EndoZip
Originated fromNitinotes, Fully Automatic Suturing Device, A Great Helper for Weight LossendozipIt is a fully automatic, operator-independent minimally invasive suturing device that safely delivers durable and effective restrictive sutures to the gastric wall.endozipNo abdominal incision is required; the treatment is performed by inserting through the mouth and esophagus into the stomach. The procedure takes approximately 30 minutes, and patients can be discharged after a short observation period post-operation.endozipAt its end, there is a suture device.SutureThe device has 8 suture needles built-in, and the suture needles remain unused before suturing.The needle is sealed inSuturingDeviceInside, avoid injuring the patient when not sutured. A 5 mm endoscope can also be inserted inside, allowing the doctor to see clearly.In the surgical area.【08】LithiX
SourceElixir Medical, Passive Shockwave BalloonLithiXIt is a passive IVL balloon catheter, which integrates multiple low-profile metal hemispheres uniformly on the surface of a semi-compliant balloon. At low balloon inflation pressure, these hemispheres interact with calcium.The formation of highly localized contact points in the tissue. Through mechanical amplification,LithiXCan create deep and wide calcified fissures while minimizing damage to soft non-calcified vascular tissue.LithiXThe mechanism of lithotripsy is based onHertz Contact Stress Principle, without the need for external energy or large equipment, achieves the expected performance of IVL through unique design while offering the versatility to treat complex calcified lesions. It creates deep and wide fissures in calcified plaques via focal stress, while minimizing damage to non-calcified vascular tissue.
【09】MicroAngioscope
Originated fromVena Medical, Disposable EndoscopeMicroAngioscopeIt is a micro intravascular endoscope with a diameter of less than 1 millimeter.Its distal end is equipped with a miniature camera and light source, enabling real-time recording of intravascular conditions. Moreover, the camera can provide real-time vascular imaging.Full-color image, alsoFor existing imaging such as DSAAn effective technical supplement. Doctors can utilizeMicroAngioscopeDirectly observe the internal condition of blood vessels and provide real-time feedback for surgical decision-making.【10】TRIA
Originated fromFoldax，Polymeric Mitral ValveTRIAAdoptFoldaxThe Revolutionary Polymer Material Developed ----LifePolymer Preparation of Mitral Valve.Lifepolymer not only has performance similar to biological valves, but also some properties superior to biological valves., such asExcellent tissue compatibility, excellent mechanical properties, long service life.Lifepolymer also changes the valve processing method from purely handcrafted to automated production, which not only reduces costs but also makes the valve quality more reliable.
