111 innovative medical device products have been approved to be listed on the old track and new blood

Medical Network, July 13 News Recently, the State Food and Drug Administration issued an announcement to approve the registration of the innovative product "Transcatheter Aortic Valve System" produced by Peijia Medical Technology (Suzhou) Co.
, Ltd.
(referred to as "Peijia Medical")
.
This also became the 111th innovative medical device project approved for listing in China
.
Since the opening of the “green channel” for innovative medical devices in 2014 , the State Drug Administration has received 1,558 special review applications for innovative medical devices, including 317 innovative program products, and 111 innovative medical devices from 92 companies have been approved for listing.
There are 1791 effective medical device standards
.
Judging from the 111 medical devices that have been approved for marketing, innovations are mainly concentrated in orthopedics, vascular intervention, surgical robots, medical AI and IVD in vitro diagnostics
.

Orthopedics Department of Orthopedics
Department of Trauma, Spine, Joints, etc.
are relatively mature, and at the same time they are facing the test of centralized procurement.
Therefore, innovation is very important
.
With the upgrading of innovation and R&D, orthopedics continues to develop towards digitalization, personalization, minimally invasiveness, precision and intelligence.
Representative innovative technologies include: 3D printing technology, digital orthopedics, tissue engineering, orthopedics regenerative medicine, orthopedics biomechanics and nano biological materials
.

　　3D printing technology
Because the 3D printing technology can customize the shape of the implant according to the needs of the patient, and can accurately control the complex microstructure of the implant, it can realize the dual adaptation of the shape and mechanical properties of the implant to the human bone.
The field of implantation is favored and developed rapidly
.
3D printing titanium orthopedic implants is one of the areas where 3D printing technology has the fastest development and most clinical transformation in the medical industry
.
Akcome Medical as a leading company in the domestic orthopedic implant industry, Started the research of 3D printing technology in 2009.
It is the first 3D printing medical product company in China, filling the blank of many Chinese metal 3D printing products
.

　　Digital Orthopedics
Digitization is the future direction of orthopedics development, and it has gradually been applied and expanded
.
Diagnostic technologies such as imaging are becoming more and more accurate, allowing infinitely detailed small quadrants to be digitized; new technologies are in the ascendant and mature day by day, and AR/VR has been applied in-depth in orthopedic surgery; intraoperative technologies such as robots and navigation have been widely used
.
The lack of professional doctors and the uneven regional medical level make the development of digital orthopedic medicine unstoppable
.


The development of 　　orthopedics biomaterials orthopedics comes with the development of materials science
.
Orthopedic implant consumables have high requirements for upstream materials, requiring high strength, good biocompatibility, mechanical compatibility, elastic modulus close to bone, strong machinability, wear resistance, low cost, etc.

.
By breaking the threshold of upstream material technology to achieve product innovation, biomaterials with bioactivity and absorbability have been gradually developed, such as artificial bone
.
Orthopedics’ innovative medical devices, 　　vascular interventional devices, have been approved for marketing, and the

vascular interventional device market is one of the largest medical device segments
.
With the collection of coronary stents, the cardiovascular market has plummeted, and innovation has become an important direction for the company's layout
.
The current vascular intervention innovations are mainly focused on heart valves and fully degradable stents
.

　　Heart valve
Heart valve refers to the valve between the atrium and the ventricle, or the valve between the ventricle and the artery.
They are the aortic valve, mitral valve, tricuspid valve, and pulmonary valve.

.
Depending on the valve to be treated, there are four treatment methods using transcatheter interventional technology, which are called: transcatheter aortic valve replacement (TAVR), transcatheter pulmonary valve replacement (TPVR), and transcatheter mitral valve replacement ( TMVR), Transcatheter Tricuspid Valve Replacement (TTVR)
.
After the centralized procurement of stents, the heart valve race track has attracted much attention due to its compliance with emerging markets, innovative attributes, great market development potential and short-term avoidance of intense price wars in centralized procurement
.
At present, the fastest growing is transcatheter aortic valve replacement (TAVR).
In the future, with technology upgrades and increased penetration, the market size of transcatheter mitral valve replacement (TMVR) will grow to the third largest in the TAVR market.
To four times
.
Compared with foreign countries, although China started late, it has shown rapid development in the past two years and has even caught up with European and American countries in some areas
.
For example, in the operation of two-leaflet valves and some complex diseases
.


The development of 　　fully degradable stents has undergone three technological innovations, from percutaneous transluminal coronary angioplasty, to bare metal stents (BMS), to the new generation of drug-eluting stents (DES), and is currently moving towards a fully degradable stent.
The era of degradable stents is advancing
.
The advantages of a fully degradable stent are: first, the stent can release the rigidity of the blood vessel after the stent is completely degraded; second, after the stent is gradually absorbed, there will be a late lumen area increase; third, it can restore the endothelial function of the blood vessel ; Fourth, there is no need to take antiplatelet drugs for life
.
With the aging of the population, the increase in the number of patients and the joint promotion of centralized procurement, the field of fully degradable stents has ushered in rapid growth, and it is also the consensus of the industry that it will become the core of the industry's development in the future
.
With the upgrading of technology, we may be in the forefront of the world in the future
.
Innovative medical device 　　surgical robot approved for vascular intervention

In recent years, personalized, precise and minimally invasive treatment methods have become an important development direction of the industry
.
Surgical robots are gradually becoming the focus of attention in the industry due to their absolute advantages over manual operations in terms of operating speed and accuracy
.
At present, surgical robots are mainly used in surgery to assist or replace doctors in surgery
.
According to the application field, it can be divided into: endoscopic surgery robot, orthopedic surgery robot, neurosurgery robot, vascular intervention robot
.
At present, the large-scale commercialization is mainly concentrated in the two fields of endoscopy and orthopedics
.


As a leading company in the laparoscopic surgical robot industry, Da Vinci 　　surgical robot of Intuitive Surgery of Laparoscopic Surgical Robot occupies a monopoly position
.
As of the end of 2019, 5,582 units have been installed globally, with operating income of nearly 4.
5 billion U.
S.
dollars
.
There are many domestic enterprises in the country, such as the dragonfly eye DFVision three-dimensional electronic laparoscopy of the minimally invasive medical robot, the Toumai endoscopic surgical robot, the Weigao Group's "smart hand" surgical robot, and the single-hole endoscopic surgical robot with Shurui technology
.


With the aging and changes in life>　　orthopedic surgical robots have increased the incidence of orthopedic diseases, and the orthopedic department itself is mature, and there are relatively few intractable diseases.
Orthopedic surgical robots are easier to replace doctors, so they are developing rapidly
.
At present, orthopedic surgical robots have been gradually applied to spine surgery, knee replacement, hip replacement and other operations
.
Take the pedicle screw placement operation as an example.
In order to accurately locate the traditional operation, it needs to be repeatedly selected for multiple times in and out, which increases the risk of nerve injury and screw damage
.
However, the robot can plan the surgical approach, direction, and nail depth through preoperative planning, and basically achieve it in one step, making the operation safer
.
There are many players in the orthopedic surgical robot market, including giants such as Medtronic’s Mazor spine surgery robot, Stryker’s MAKO joint surgery robot, and Zimmer’s MedTech spine surgery robot
.
Currently layout navigation robot business day-flight, minimally invasive medical, Shandong Weigao, Rosen Bot, Weizhuo Zhiyuan, a long Mugu, intelligent yuan, three altar medical, robotics and other key Kerry
.
Surgical robots have been approved for the market’s innovative medical devices.

　　Medical AI.

Medical AI is based on the Internet.
Through the construction of infrastructure and data collection, artificial intelligence technology and big data services are applied to the medical industry.
The penetration of artificial intelligence allows The medical industry is even more powerful
.
At present, the main application directions of medical AI are medical imaging, auxiliary diagnosis, new drug research and development, and health management
.
With the accelerated approval of the three types of AI certificates and the coordinated development of capital and technology, medical AI has entered a stage of rapid development
.
It is predicted that the medical AI market will reach US$25.
4 billion in 2025, and it will be one of the fastest growing tracks in the next five years
.

Innovative medical devices approved for marketing by 　　medical AI