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NMPA Recognized Innovative Devices in 2022

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The following 32 innovative devices NMPA have been mentioned in 2022 Innovation Approval Notices published by the NMPA. China Med Device, LLC categorized them by indications:

Cardiovascular

Thoracic aortic stent system:

The product consists of a proximal thoracic aortic stent graft system and a distal thoracic aortic bare stent system. The proximal thoracic aortic stent-graft system seals the proximal breach of type B dissection and promotes thrombosis in the false lumen; the distal thoracic aortic bare stent system expands the distal true lumen of the descending aorta and promotes the remodeling of the aortic lumen. The structural design of the stent makes it have good flexibility and certain radial and axial support. The thoracic aortic stent-graft and the thoracic aortic bare stent are pre-installed in the corresponding conveyors respectively. The design of the conveyors can ensure the stability of the release process and the precise positioning of the stents.

Aortic dissection has an acute onset, rapid progression, and high mortality rate. Stent products have become the main means of endovascular interventional treatment for this type of disease. This product is suitable for the treatment of Stanford type B dissection, the length of the proximal anchoring area of the stent is ≥15mm, and the lesion meets one of the following conditions: 1. There is a distal breach, and it is necessary to treat the distal lesion; 2. The dissection involves a wide range, and the distal true cavity collapses; 3. Dissection with distal poor perfusion. The launch of this product will bring new treatment options to patients.

Transcatheter Implantable Leadless Pacing System:

The system consists of an implantable pulse generator (with fixed wings) and a delivery catheter. It can sense the patient’s heart activity in the right ventricle, monitor the rhythm of bradycardia and provide pacing therapy for bradycardia. The system is a medical device with safe magnetic resonance environment conditions. Under the specified conditions and the guarantee of special protection measures for patients and implanted equipment, patients can accept clinical magnetic resonance imaging examinations with field strengths of 1.5T and 3.0T.

Compared with traditional pacemakers, this system only needs to implant a single pulse generator in the ventricle to provide atrioventricular synchronous pacing, without the need for a subcutaneous bag for placing a pacemaker and a vein connected to the atrium and ventricle. Leads to reduce pocket and lead-related complications. When using this system, patients with blocked veins can also be implanted with a pacemaker because there is no need to pass the pacemaker lead through the vein or tricuspid valve.

Based on the previous generation of products, the system adds mechanical sensing and atrioventricular synchronous pacing technology, and uses the built-in three-axis accelerometer to sense atrial mechanical signals in the ventricle to achieve atrioventricular synchronous pacing, which is compatible with the existing VVI single ventricular pacing Compared with AV-synchronous pacing, AV pacing can increase the blood volume in the ventricle, resulting in an increase in stroke volume per ventricular beat, resulting in a corresponding clinical benefit.

The system adopts mechanical sensing and atrioventricular synchronous pacing technology in the leadless pacemaker, which is the first at home and abroad.

Transcatheter prosthetic pulmonary valve system:

This product consists of a pulmonary valve and a delivery system, where the delivery system includes a delivery catheter system and a compression loading system. The pulmonary valve is composed of a self-expandable nickel-titanium alloy stent, a valve leaflet and skirt made of pig pericardium, and sutures. The pulmonary valve’s The design can make the anchoring of the valve stent more stable, suitable for patients with a larger range of pulmonary valve annulus in different anatomical shapes, and at the same time make the delivery of the stent safer and the blood flow smoother. The design of the delivery system allows the valve to be compressed uniformly, Improved loading efficiency and reduced risk of radial collapse upon valve deployment.

This product is suitable for patients with severe pulmonary regurgitation (≥3+) after surgery for congenital heart disease (age ≥12 years old, body weight ≥30kg) with a native right ventricular outflow tract, and must meet certain clinical conditions (see product for details) scope of application). The launch of the product will bring new treatment options to patients. “

Implantable Left Ventricular Assist System:

The product consists of implant components (blood pump, ventricular sewing ring, artificial vascular protection frame), surgical tools (heart opening tool, tightening tool, percutaneous wire traction tool, inlet tube protective cap, surgical percutaneous wire extension wire),  external components (controller, controller power extension cable, AC power adapter, lithium-ion battery, battery charger, monitor (optional), monitor data cable (optional), patient backpack and shower bag).

This product is used in conjunction with specific artificial blood vessels to provide mechanical support for blood circulation in patients with advanced refractory left heart failure and is used for transitional treatment before heart transplantation or to restore heart function. It is intended for use by medical institutions with heart transplantation conditions and postoperative comprehensive care capabilities. Medical staff, out-of-hospital nursing staff and patients must pass corresponding training. Patients who are intolerant to anticoagulant therapy are contraindicated.

This product adopts main core technologies such as pump-machine integrated design, magnetic liquid levitation, internal flow channel optimization, and dual-redundant drive, all of which have independent intellectual property rights. The ventricular assist system, its key technical indicators have reached the international level.

Left atrial appendage occluder system:

The left atrial appendage occluder system consists of a left atrial appendage occluder and a conveyor, wherein the left atrial appendage occluder is connected by a sealing disc and an anchoring disc. The delivery device consists of a delivery sheath, dilator, loader, delivery cable and hemostatic valve. The design of the sealing disc and anchoring disc of this product adopts an innovative patented design, which makes full use of the self-adaption of the nickel-titanium wire braided structure and can meet the clinical needs for occlusion of different shapes of left atrial appendages to a certain extent.

This product is suitable for patients with non-valvular atrial fibrillation who are at risk of stroke (CHA2DS2-VASc score ≥ 2 points) and who are contraindicated for long-term oral anticoagulation therapy.

Intravascular ultrasound diagnostic equipment:

This supporting product uses the principle of pulse echo to perform ultrasonic scanning and imaging of blood vessels. The device host and the catheter controller send excitation pulses to the ultrasonic transducer located at the distal end of the catheter, and at the same time drive the transducer to rotate at a high speed through the drive shaft inside the catheter sheath. The transducer sends out ultrasonic pulses and receives ultrasonic echoes reflected by vascular tissue. The wave signal is amplified, collected and preprocessed by the catheter controller and then transmitted to the host computer to realize the display and processing of blood vessel images.

The intravascular ultrasonic diagnostic equipment adopts all-digital signal transmission and single-array element mechanical rotation design. Digital transmission is realized between the catheter controller and the imaging host, which improves the integration and stability of the system while reducing costs and reducing image noise.

Single-use intravascular ultrasound diagnosis catheter:

Disposable intravascular ultrasonic diagnostic catheter, which is on the PMN-PT high-frequency single crystal composite transducer, uses a glue-free layer with a thickness of ≤ 15 μm by evaporation is used to achieve high-performance high-frequency transduction The localization of the production of the device improves the image resolution and optimizes the image quality.

This supporting product uses high-frequency, wide-bandwidth, and high-sensitivity ultrasonic imaging, which can realize coronary artery scanning imaging and blood vessel diameter measurement, help doctors judge the severity and nature of lesions, and help improve the understanding and guidance of coronary artery lesions Intervention.

Ear, Nose, and Throat

ENT dual-source cone beam computed tomography equipment:

The product consists of a large field of view imaging system, a small field of view imaging system, a control device, a scanning bed, a headrest, a frame, a laser positioning light, and a workstation. X-ray cone beam tomography for ear, nose, throat airways, oral and maxillofacial areas.

This product is the world’s first dual-source, dual-detector oral CBCT product. Its core technology is dual-source imaging technology. It uses small focus, high-power X-ray tube heads and high-resolution detectors to improve spatial resolution. Based on oral and maxillofacial imaging needs, X-ray cone beam tomography can be provided for ENT diseases. Its large-field imaging system is used for routine imaging examinations of the oral cavity, maxillofacial region, nose, and throat airways. The small-field imaging system has high spatial resolution and is used for imaging examinations of internal organs of the ear (middle ear, inner ear).

Gastroenterology and Urology

Digestive tract vibrating capsule system:

This product stimulates the colon wall through vibration, promotes colon peristalsis, and provides a new treatment method for adult functional chronic transit constipation whose drug treatment is not effective. This product is the first of its kind, and there is no similar product on the market at home and abroad. The innovations of this product: First, the capsule has the ability to detect acceleration, and the capsule can be activated by monitoring the change of the acceleration value; second, the product is a non-drug treatment, which can be used as another treatment plan for people with functional constipation.

At present, although there are many methods to choose from in the treatment of constipation, there are high prevalence, side effects, high recurrence rate and low patient satisfaction. This product is expected to improve the quality of life of the applicable population.

Ultrasound diagnostic equipment for gastrointestinal endoscopy:

The product consists of ultrasound probe, probe driver, image processor, keyboard and foot switch. Used in conjunction with an independently powered monitor, it is used for ultrasonic imaging of the human digestive tract (including esophagus, stomach, duodenum, and colon) and surrounding tissues.

This product is an ultrasonic diagnostic equipment used in conjunction with gastrointestinal endoscopy. When in use, the ultrasonic probe enters the digestive tract of the human body through the working channel of the digestive endoscope, and the ultrasonic image processor outputs control signals, and the probe driver drives the flexible shaft in the ultrasonic probe to rotate, driving the front-end single-array ultrasonic transducer to perform mechanical ring scanning , to transmit ultrasonic pulses to the inspection site, after obtaining the ultrasonic echo signal, the ultrasonic image processor processes the signal, and can present a two-dimensional black and white image on the monitor for ultrasonic diagnostic examination.

The echo signal sensitivity of the ultrasonic probe of this product has been increased by 20%, and the relative bandwidth has reached 40%. On the basis of ensuring the space size of the probe, the echo signal is increased, the weak tissue signal is enhanced, the imaging accuracy of single reception can be guaranteed, and the detection depth and resolution of the two frequency ultrasonic probes (12MHz, 20MHz) are increased.

Disposable cryoablation balloon catheter:

The product consists of a balloon, a catheter body (vacuum outer tube, vacuum inner tube, return tube, intake tube, buffer tube, protection tube) and a handle (handle base, loop connecting tube, vacuum connecting tube, joint). It is used in conjunction with specific cryoablation equipment for adjuvant cryoablation in adult patients with T1 stage non-muscle invasive bladder cancer (NMIBC) after the first transurethral resection of bladder tumor (TURBt).

At present, there is no cryogenic medical device for bladder tumors in China. The domestic probe-type cryomedical device is limited to the application of solid tumors, and the imported balloon-type cryomedical device is limited to the application of the cardiovascular system. The core technology of this product is that the catheter head adopts an innovative balloon structure design, and the distal end of the balloon is concave, which can realize effective freezing of the side and distal end of the balloon. A buffer unit is also designed at the distal end of the balloon, which can increase product safety and facilitate the delivery of the catheter.

Laparoscopic surgery system:

The doctor console of this product is the core part of the laparoscopic surgery system. Doctors control the 3D endoscope and surgical instruments through two main hand controllers and foot pedals to perform surgical operations on patients. The patient operating platform is the operating part of the laparoscopic surgery system, and its main function is to support surgical instruments and laparoscopic equipment. With the operation of the main hand controller and foot pedal device on the doctor’s console, the robotic arm system makes corresponding operations. The joints of each robotic arm have multiple degrees of freedom of movement, which can improve the flexibility and precision of the operation. Human hands tremble naturally. Surgical instruments assist in the completion of surgical cutting, suturing, clamping and other work.

This product has independent intellectual property rights. Compared with traditional laparoscopic surgery, this product can improve the quality of surgery and ensure the safety of the operation. Compared with imported products, it can reduce the cost of treatment and reduce the economic burden of the patients.

Electronic colonic endoscopic imaging assisted intestinal polyps:

This product is provided in the form of a CD, and can be installed and used in a stand-alone mode. It has 9 functional modules including acquisition card management, authorization management, drawing detection area, sound prompt, display options, display software information, monitoring running time, processing algorithm management, and main program. The product is only used in conjunction with specified models of electronic colonoscopes in medical institutions, for licensed doctors to display suspected polyp areas in real-time on the output independent video images during adult colonoscopy examinations. This information is for reference only, and doctors should make clinical decisions based on the patient’s condition.

The working principle of this product is to import video images from the video signal output port of the endoscope image processor, find out the suspected polyp position after software processing and algorithm analysis, and display it on a separate monitor. This product is the first domestic medical device software that uses deep learning technology to assist in the detection of polyps in endoscopic images. It uses small sample deep learning technology and local labeling technology to select and develop the algorithm model framework. The overall performance of the algorithm is not bad. Relying entirely on the increase of training data, it can achieve high performance, strong generalization and robustness under smaller samples.

This product is used in conjunction with an electronic colon endoscope, which can help doctors find out the location of suspected polyps during colonoscopy, which is conducive to earlier detection of precancerous lesions of rectal cancer, thereby reducing the incidence and mortality of rectal cancer.

Oxidized Regenerated Cellulose (ORC) powder:

The product consists of model 3013SP, regenerated oxidized cellulose absorbable hemostatic particles (prepacked with device), and model 3123SPEA, regenerated oxidized cellulose absorbable hemostatic particles endoscopic administration catheter set. Both are radiation sterilized and single-used. Model 3013SP is an applicator preloaded with 3g of hemostatic granules made of compacted fine fibers through a patented process for open surgery; model 3123SPEA can be used in conjunction with 3013SP for endoscopic surgery.

This product is suitable for surgical or endoscopic surgery (except ophthalmology, neurosurgery, and urology), when ligation or other traditional control methods are not applicable or ineffective, as an auxiliary control of capillary, venule, and arteriole bleeding. This product is the first granular regenerated oxidized cellulose hemostatic product. Its granules are made of compacted fine fibers by a patented process. Applications in speculum surgery.

Anastomosis reinforcement patch:

Anastomotic reinforcement patches include tubular type, flat type, and round type. The tubular type and the round type are composed of three parts: patch, backing, and traction line, and the flat type only has the patch. The patch is made of acellular porcine small intestinal submucosa material, and the backing is sutured and fixed with a traction thread. Flat sheet without backing and drawstring.

This product is a biodegradable anastomotic stoma reinforcement product, and its production process achieves the removal of animal tissue immunogenicity while retaining the structure and biological activity of the natural extracellular matrix; its structural design enables the product to be matched with various types of staplers and improve surgical safety. This product cooperates with the stapler to reinforce the anastomotic site, and is suitable for distal gastrectomy, proximal gastrectomy, sleeve gastrectomy, and gastrointestinal anastomosis, and can reduce anastomotic leakage and bleeding after gastrointestinal resection and other related complications, bringing benefits to patients.

Hematology

Artificial blood vessels:

The artificial blood vessel is mainly made of braided PET thread, coated with bovine collagen and glycerin. The polyester weaving of this product adopts an innovative weaving process, the outer warp yarn is made of elastic yarn (polyester low elastic yarn DTY yarn), the middle layer is made of non-elastic yarn (polyester full-drawn FDY yarn), and the weft yarn is made of elastic yarn, Composite yarns composed of non-elastic yarns. This weaving process results in fabrics with smaller and more uniform pores, which is expected to improve the bleeding properties of the finished product. Artificial blood vessels are used for replacement or bypass surgery of the aorta and its branches. The launch of this product will provide more options for clinical treatment.

Microbiology

Encephalitis/meningitis multiple pathogen nucleic acid combination detection kit:

This product consists of FilmArray ME test strip, sample buffer, lysate, disposable red sample injection tube and individually packaged pipette. It is a disposable closed detection reagent for qualitative detection in vitro of meningitis and/or Nucleic acids of 14 bacterial, viral, and cryptococci in cerebrospinal fluid (CSF) samples from people with signs and/or symptoms of encephalitis.

This product adopts the closed nested multiple PCR melting curve method, based on the multiple nested PCR amplification, and melting curve analysis technology, to detect and analyze the samples after mechanical grinding and crushing. Multiple nested PCR amplification combined with melting curve analysis technology improves the reaction sensitivity and specificity of the detection kit, and the system software automatically evaluates the data and reports the results.

The product detects and identifies 14 potential central nervous system infection-related pathogens in CSF, and the test results can be obtained in about 1 hour, which speeds up the etiological diagnosis of encephalitis and meningitis, so that targeted clinical treatment can be carried out as soon as possible, reducing the risk of encephalitis. The burden of diseases such as meningitis on patients.

Neurology

Dual-channel implantable deep brain stimulation system:

The pulse generator set, electrode lead set and extension lead set products need to be used together to generate electrical stimulation pulses and stimulate the subthalamic nucleus (STN), which is used for the treatment of late-stage levodopa-responsive Pain that cannot effectively control certain symptoms with drugs. Combination therapy in patients with Kinson’s disease.

The above-mentioned products have anti-interference design, can accept 3.0T magnetic resonance imaging examination, have complete independent intellectual property rights, and are the first medical devices in China. Lead Set and Extension Lead Set products utilize a manufacturing technique of a braided composite conductive shield structure that wraps around the lead to significantly reduce temperature rise due to radio frequency fields. Patients implanted with this type of product can not only safely undergo MRI scans under 1.5T MRI equipment, but also scan under 3.0T MRI equipment to obtain high-quality MRI image data.

Navigation and positioning system for neurosurgery:

The product consists of infrared camera, workstation, bracket, positioning components (probe, reference frame, connector, reflective ball, surgical instrument adapter), laser probe, hand-held laser sight, foot switch, and automatic positioning device. For navigation and orientation of neurosurgical instruments and implants.

This product mainly adopts core technologies such as multi-modal image fusion, laser surface registration, and automatic positioning device. This product can improve the efficiency of surgery on the basis of ensuring positioning accuracy and can realize the basic functions of the robotic arm.

Implantable spinal cord stimulation system: One of the implantable spinal cord stimulation electrode products consists of implantable spinal cord stimulation electrodes, electrode anchors, tunneling tools, simulated electrodes, surgical electrode channelers, torque screwdrivers and spare electrode anchors. Another implantable spinal cord stimulation electrode product consists of implantable spinal cord stimulation electrodes, electrode anchors, tunneling tools, guide wires, puncture needles, steel wires, torque screwdrivers and spare electrode anchors. The implantable spinal cord stimulation extension lead consists of an extension lead, a sleeve, a backup screw, a tunneling tool, and a torque screwdriver. The above-mentioned products are used in conjunction with an adapted implantable spinal cord nerve stimulator for patients aged 18 and over (except pregnant women) for adjuvant treatment of chronic intractable pain in the trunk and limbs.

Implantable spinal cord stimulation electrodes and implantable spinal cord stimulation extension leads mainly adopt high-density connection and anti-bending fatigue core technologies, and use new sandwich electrode anchors to enhance the fixing force of electrodes and reduce the electrode displacement rate. It is the first domestic medical device.

Implantable rechargeable spinal cord stimulator:

The above products are composed of a pulse generator, a torque screwdriver, and a plugging head. Used in conjunction with the adapted implantable spinal cord stimulation electrodes and implantable spinal cord stimulation extension leads, it is used by patients aged 18 and above (except pregnant women) and is used for adjuvant treatment of chronic intractable pain in the trunk and limbs.

The core technologies of the above products mainly include adaptive stimulation technology, multi-site synchronous stimulation technology, remote monitoring, and program control technology, among which the implantable rechargeable spinal cord nerve stimulator has wireless charging technology. The product has obtained the independent intellectual property rights and is the first medical device in China. The preset stimulation parameters can be automatically invoked according to the patient’s posture, so that the patient can reach a satisfactory treatment state. With remote program control function, parameters can be adjusted remotely, reducing the number of times patients go to and from the hospital.

Patient Programmable Charger:

The product consists of a power adapter, a charging controller, a charging coil and a charging belt assembly. For patients aged 18 and above (except pregnant women), it is used to charge and program the adapted rechargeable implantable spinal cord stimulator.

The core technology of this product is near field/Bluetooth dual backup safety communication technology, remote program control technology and wireless charging technology. It can directly establish a Bluetooth connection with the pulse generator to improve the patient’s experience of receiving program control. The product has two secure communication technologies, near field and Bluetooth. When one communication mode fails, the other communication mode can be enabled. Bluetooth communication is usually turned off by default to avoid device failure or parameter changes caused by mistakenly connecting other Bluetooth devices. When patients need program control, they can wake up the Bluetooth communication program control function through near-field communication.

This product is part of the spinal cord stimulation system. The spinal cord stimulation system can provide patients with more treatment options, automatically call the pre-parameters according to the patient’s posture, and realize the remote program control function in a more refined way. The hospital realizes the method of parameter adjustment, which can reduce the number of times patients go to and from the hospital.

Ophthalmic

Aspheric diffractive multifocal intraocular lens:

The aspheric diffractive multifocal intraocular lens is a one-piece/posterior chamber intraocular lens, which is foldable and has a modified L-shape. The main body and supporting part of the product are made of ethyl acrylate and ethyl methacrylate copolymer materials, added with ultraviolet absorbers, and the surface is modified by heparin. The innovation of this product lies in the combination of diffraction spectroscopic and aspheric surface in its optical part. Diffraction technology is the core of realizing multi-focus, which is the first in China.

This product is used for vision correction of adult cataract patients, and it is expected to provide two focal points, far and near, to make up for the poor vision of single-focal intraocular lenses to a certain extent. The launch of the product will bring new treatment options to patients.

Orthopedic

Hip replacement surgery navigation and positioning system:

The product consists of a robotic arm system, optical positioning system, navigation control system, preoperative planning software, foot switch, encryption device, and accessories. For use only with proven hip prostheses and surgical tools for navigating surgical tools and hip prostheses during adult hip replacement surgery.

The core technology of this product mainly includes technologies such as spatial registration, robotic arm control, and safety boundary control. In the hip joint replacement operation, the mechanical arm with its degree of freedom is used and has the function of safety boundary control, assisting the doctor to complete the work of acetabular grinding, femoral osteotomy, hip joint prosthesis installation, etc. Compared with traditional artificial hip joint replacement, it can Ensure the accuracy of surgical positioning, reduce the probability of adverse events and complications, and reduce the radiation damage of X-rays to doctors and patients.

Radiology

CT image-assisted triage software for intracranial hemorrhage:

The product consists of a server-side and a browser-side. The server side consists of a data access and storage module, a data synchronization module, and an image processing module based on deep learning algorithms; the browser side consists of a patient management module, a result display and editing module, and a service module. The software is delivered via FTP download.

This product is the first domestic artificial intelligence medical software based on deep learning technology to realize intracranial hemorrhage triage prompts and measurement analysis. It adopts deep learning-based intracranial hemorrhage detection and segmentation algorithm to realize intracranial hemorrhage triage prompts and quantitative analysis of bleeding volume. , It can display, process, measure and analyze brain CT plain scan images, and it can be used for triage prompts for patients with intracranial hemorrhage in hyperacute and acute stages. It is clinically used by trained and qualified physicians and cannot be used alone as the basis for clinical diagnosis and treatment decisions.

This product innovatively uses artificial intelligence algorithms to calculate and analyze patient images in real time, improve the speed of diagnosis, quickly screen out patients with suspected intracranial hemorrhage in the hyperacute and acute stages, and provide references for doctors to assess the degree of criticality and formulate clinical plans, effectively Help patients diagnose and treat as early as possible.

Mobile head and neck MRI system:

The product consists of permanent magnet, gradient amplifier, gradient shimming coil, radio frequency amplifier, radio frequency transmitting coil, head coil (optional), head and neck joint coil (optional), spectrometer, temperature controller, digital shimming unit, mobile It consists of a device, a shielding cover, a hospital bed, and an alarm unit for clinical MRI diagnosis of the head and neck.

The product has the characteristics of movable, small size, light weight, and integrated structure. It can be deployed inside a medical institution outside a fixed shielding room and connected to a 220V AC/10A network power supply; it can also be moved to different locations in a medical institution for close examination of patients, expanding the installation range of magnetic resonance products.

Disposable intravascular imaging catheter:

The disposable intravascular imaging catheter consists of an outer sheath, an imaging shaft, a pressure extension tube, and a three-way connection. The outer sheath includes a connector, a connector protection cap, a flushing port, a pullback tube, a stroke tube, a proximal sheath, a distal sheath, a quick exchange head and a developing ring, and the imaging axis includes a connector, a torsion spring, and a probe. The probe in C1-1 type is ultrasonic probe and optical probe; the probe in C2-1 type is ultrasonic probe; the probe in C3-1 type is optical probe.

In the design of this product, through miniaturization design and micromanufacturing, the size of the probe is reduced, the optical probe and the ultrasonic probe are arranged in front and back, and optical fibers and electrical wires are used to connect them, ensuring that the overall thickness of the catheter is basically unchanged. In addition, this product integrates the two functions of intravascular ultrasound (IVUS) and intravascular optical coherence tomography (OCT). Taking advantage of the advantages of the two technologies also simplifies the doctor’s operation and improves the accuracy and safety of imaging. Meet the doctor’s requirements for resolution and penetration. After fast imaging, images can be played back at the speed required by clinicians to provide more information for doctors to diagnose.

Intravascular imaging equipment:

The intravascular imaging device consists of a host, a probe interface unit (PIU), a cart assembly, and a monitor. The device is used in conjunction with a single-use intravascular imaging catheter connection for intravascular imaging of coronary arteries during percutaneous coronary intervention procedures. The device uses the PIU to control the imaging catheter to drive the probe to rotate and retract 360°, and the imaging section completes the scanning of blood vessels. At the same time, the device emits near-infrared light and ultrasound, the interferometer and ultrasound module record the reflected light and ultrasound emission of blood vessels at different depths, and the host reconstructs the reflected light signal and ultrasound reflection signal to form intravascular ultrasound images and intravascular optical interference tomographic images.

In terms of product design, the device has designed a synchronous circuit, which can realize the registration of the two images by detecting the positional relationship between the intravascular ultrasound (IVUS) probe and the intravascular optical coherence tomography (OCT) probe, and using a correction algorithm. Synchronized imaging. The device integrates the two functions of IVUS and OCT. Compared with the products that have been marketed and only have single-function imaging, it can realize the above two imaging simultaneously. Meet the doctor’s requirements for resolution and penetration. After fast imaging, images can be played back at the speed required by clinicians to provide more information for doctors to diagnose.

Gamma Beam Stereotactic Radiation Therapy System:

The product consists of host system, electrical control system, radiotherapy planning system software, treatment control system software, image guidance system and radiation field verification system. For image-guided stereotactic radiation therapy to the head, radiosurgery and stereotactic body radiation therapy for solid tumors and lesions.

This product integrates KV-level CBCT image-guided technology and real-time orthogonal imaging image-guided technology. It has independent intellectual property rights and is the first image-guided gamma-ray stereotactic radiotherapy equipment in China. The product adopts a drum structure design, and a KV-level X-ray image guidance module and an MV-level EPID module are installed on the drum, which are coaxial and coplanar with the focus therapy head in structural layout, which can realize CBCT imaging technology and orthogonal imaging technology. Image-guided setup verification and real-time image guidance based on orthogonal imaging technology. This product can perform image-guided setup verification on patients based on CBCT imaging technology and orthogonal imaging technology before treatment. The imaging system detects the setup deviation of the patient before treatment and informs the control system to make necessary position adjustments to ensure correct positioning The planned treatment target area is sent into the treatment area; during the treatment process, real-time image guidance based on orthogonal imaging technology can be carried out. The real-time image guidance technology can monitor the change of the patient’s position in real time, and adjust the position error of the patient beyond the clinically acceptable range in real time. , to ensure the position accuracy of the target area of radiotherapy, improve the clinical efficacy of radiotherapy, avoid unnecessary irradiation of normal tissues, and ensure the position accuracy of patients during treatment.

In addition, the product is based on the EPID field verification system, which optimizes the daily quality control workflow, and can be used to measure the size and position of the output field of the collimator in the daily quality control process, verify the position accuracy of the collimator, and ensure the irradiation Dosage accuracy improves product reliability and provides basic guarantee for precise treatment.

For more information, contact us at info@chinameddevice.com.

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