Medpark's WuShuang Medical and Huiyang Medical Enter NMPA Innovation Green Channel with Breakthrough Cardiovascular Devices
Medpark
Bone Graft Material Developer
Singular Medical
Developer, Manufacturer, and Seller of Cardiac Rhythm Management Products
Two Enterprises within Medpark
Singular Medical Implantable Cardiac Event Monitor
Singular Medical Radiofrequency Atrial Septal Puncture Device
Respectively obtainedNational Medical Products Administration (NMPA) Approval
Officially entered on June 13 after the public announcement period.
Special Review Procedure for Innovative Medical Devices
(Publicly disclosed 9 items, 2 of which are from Suzhou New District)
PART/ 01
Singular Medical Implantable Cardiac Monitor (ICM)
(Implantable ECG Event Monitor System Diagram)
The implantable cardiac monitor (ICM) approved this time，YesThe First Implantable Cardiac Monitor (ICM) Product to Enter the Innovative Special Review Process. This product has full independent intellectual property rights, can accurately detect various types of arrhythmia ECG signals, and is equipped withUltra-large ECG storage capacity. As the first ICM in China, its titanium alloy body exhibits excellent biocompatibility. It not only breaks through traditional ICM technical barriers and covers home monitoring but also is the first to be equipped with Bluetooth telemetry, supporting real-time cloud transmission via mobile phone to provide more timely diagnostic and treatment assistance functions. This ICM has successfully completed type inspection and animal experiments, entering the clinical trial stage.
Singular MedicalSingular Medical is a leader in the independent research, development, and production of cardiac rhythm management (CRM) medical devices in China, committed to creating high-end CRM medical devices for China.
Singular Medical's product line covers Implantable Cardioverter Defibrillators (ICD), Insertable Cardiac Monitors (ICM), CSP pacing systems, and external heart failure monitoring devices. The company has built an elite team consisting of experienced and technically proficient engineers and industry veterans, aiming to provide high-quality and convenient medical products and services to benefit more patients.
In 2022, Singular Medical wasNamed "2022 Best Medical Technology Company in China" by U.S. Medtech Outlook Magazine; Selected in 2023"Forbes Asia's 100 Companies to Watch" list, the company's professional capabilities have gained international attention; in May 2024, the company's ICD product proudly ranked"VBEF2024 Annual Medical Health Industry Innovation Product List"`, the industry has fully recognized the outstanding contributions and remarkable achievements of Singular Medical in the medical field.`
PART/ 02
Singular Medical RF-CROSS Radiofrequency Atrial Septal Puncture Device
The RF-CROSS radiofrequency atrial septal puncture device approved this time isAn innovative device that achieves a dual-function of mechanical/radiofrequency atrial septal puncture and "zero" exchange during the procedure, a first in China.Currently, the RF-CROSS RF Transseptal Puncture Device has completed its first clinical cohort. The product advantages are as follows:
1）Combining Mechanical and Radiofrequency, with both mechanical atrial septal puncture and radiofrequency puncture methods available. Doctors can switch between mechanical/radiofrequency puncture modes at any time according to clinical conditions, meeting various clinical needs;
2）"Intraoperative '0' Exchange", Integrated design of puncture needle, dilator, and guidewire; zero exchange of puncture needle and guidewire, significantly reducing surgical steps and shortening operation time;
3）With Safety and ReliabilityThe puncture needle is pre-assembled inside the dilator, and the radial movement distance during the operation is only 7mm, avoiding the risk of foreign matter shedding caused by the traditional curved puncture needle scraping the inner wall of the dilator when penetrating it.
4）Self-retracting needle, The puncture needle tip is exposed only when the doctor presses the push button, and automatically retracts into the dilator tube once the button is released, ensuring surgical safety;
5）HasOpen CompatibilityThe product is compatible with a variety of mainstream deflectable guiding sheaths, allowing for the placement of the guiding sheath immediately after puncture, further reducing surgical steps.
Huiyang MedicalFounded in 2021, it is a Gusu Leading Talent and High-Tech Zone Leading Talent enterprise in Suzhou City. The company has deep cooperation with many well-known universities, hospitals, and clinical centers both in China and abroad. Closely aligned with the actual needs of patients and operators, it focuses on the research, development, and manufacturing of innovative high-end medical devices in the fields of cardiac electrophysiology and structural heart disease.
Currently, the cardiovascular access product family of Singular Medical, centered around RF-CROSS, has entered the clinical and registration submission stage. Another key product line, the structural heart product family, is also under rapid development and has recently moved into the animal testing phase.
To enter the special review process for innovative medical devices, three basic conditions must be met:
(1) The applicant, through its leading technological innovation activities, legally owns the core technology invention patent rights of the product in China, or has obtained the invention patent rights or its usage rights in China through legal transfer. The application time for special review of innovative medical devices is no more than 5 years from the patent authorization publication date; or the core technology invention patent application has been disclosed by the State Council's patent administration department and a search report has been issued by the Patent Search and Consultation Center of the National Intellectual Property Administration, stating that the core technical solution of the product possesses novelty and creativity.
(II) The applicant has completed the preliminary research of the product and has a basically finalized product. The research process was genuine and controlled, and the research data is complete and traceable.
(III) The main working principle or mechanism of action of the product isFirst of Its Kind in China, the product performance or safety has fundamentally improved compared to similar products and is technologicallyInternational leading level, with significant clinical application value。
This time MedparkTwo Enterprises in MedparkEntering the special innovative review channel is an affirmation of the company's outstanding achievements in the field of medical device innovation, and more importantly, a high recognition of Medpark's continuous efforts and remarkable contributions to promoting the innovative development of medical devices.
In the face of these inspiring achievements, Medpark will unwaveringly continue its strategic path led by digitalization, driven by innovation, and focused on cluster development. To further enhance industrial competitiveness, Medpark will strive to continuously explore and highlight its unique strengths to precisely meet the needs of medical device companies in product development, technology upgrading, and achievement transformation.
Medpark will continue to optimize the industrial ecosystem by gaining an in-depth understanding and analysis of the specific needs and challenges faced by enterprises, providing targeted solutions. Medpark will establish a more efficient and convenient service system to offer comprehensive support to companies from research and development to market transformation, promoting their innovation process and accelerating the output and application of innovative achievements.
