Developments of Innovative Medical Devices in July

  • 2022-08-15

Eight products entered the innovative product approval track and six innovative medical devices were approved for marketing.
According to the statistics of Joinchain, in July, eight products entered the innovative product approval track, covering areas such as surgical robots, diagnostic reagents, and surgical instruments, and six innovative medical devices were approved for marketing, covering areas such as intestinal polyp diagnosis and treatment and implantable left ventricular assist systems.
What is “new” about these medical devices? What new opportunities will they bring to the related diagnosis and treatment areas?

01
“New” devices that entered the innovative product approval track

Company name

Innovative product for approval

Application area

Easymonitor

Anesthesia depth monitoring and drug delivery system

Respiratory, anesthesia, and first-aid devices

Ailin Medical

Transjugular intrahepatic puncture instrument

Nerve and cardiovascular surgical instruments

United Imaging

Medical X-ray angiography machine

Medical imaging devices

Rossum Robot

Pelvic fracture reduction surgery navigation and positioning system

Active surgical instruments

Lvdong Medical

3D positioning intracardiac guidance kit

Medical examination and monitoring devices

Remedicine

Pulsed-field ablation equipment

Active surgical instruments

Jianbo Biotechnology

Carbapenemase detection kit (emulsion process)

Orthopedic surgical instruments

Naton Biotechnology

Personalized knee surgical guide

In vitro diagnostic reagents



02
“New” devices approved for marketing

Company name

Innovative device approved for marketing

Application area

Wision Medical

Electronic colonoscopy image-assisted detection software for intestinal polyps

Adult colonoscopy

Ethicon

Absorbable Hemostat (oxidized regenerated cellulose) granules

Small venous and arterial hemorrhage in surgical procedures

LargeV

Ear/nose/throat dual-energy cone beam computed tomography equipment

X-ray cone beam computed tomography for ear/nose/throat, etc.

RocketHeart Technology

Implantable left ventricular assist system

Bridges to heart transplantation or restoration of heart function

Our United Corporation

Gamma Knife stereotactic radiosurgery system

Solid tumor radiosurgery

Venus Medtech

VenusP-Valve

Severe pulmonary regurgitation


Wision Medical: China’s first medical device software that uses the deep learning technique to assist in polyp detection
The “electronic colonoscopy image-assisted detection software for intestinal polyps” produced by Chengdu Wision Medical Device Co., Ltd. can be used together with electronic colonoscopes to help doctors locate suspected polyps during colonoscopy and facilitate earlier detection of precancerous lesions of rectal cancer, thereby reducing the incidence and mortality thereof.

According to the National Medical Products Administration, it is China’s first medical device software that uses the deep learning technique to assist in the detection of polyps in endoscope images; it uses the few-shot learning and local labeling techniques for algorithm model framework selection and development, with the overall algorithm performance not depending entirely on the increase of training data, therefore, it can realize high performance and strong generalization and robustness in a small sample size.

Ethicon: First granular oxidized regenerated cellulose product for hemostasis
The “Absorbable Hemostat (oxidized regenerated cellulose) granules” produced by Ethicon, LLC under Johnson & Johnson is used adjunctively in surgical or endoscopic procedures (except those in ophthalmology, neurosurgery, and urology) to assist in the control of capillary and small venous and arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.

It is learned that the product is the first granular oxidized regenerated cellulose product for hemostasis, with granules made of fine fibers compacted by a patented process, and its supporting powder application device can avoid the surgical instrument from affecting the effective and uniform spraying of the granules, to facilitate its application in surgical or endoscopic procedures.

LargeV: World’s first dual-energy dual-detector dental CBCT product
The “ear/nose/throat dual-energy cone beam computed tomography equipment” produced by LargeV Instrument Corp., Ltd. can be used for X-ray cone beam computed tomography of the ear, nose, laryngopharynx, airway, and oral and maxillofacial region. It is the world’s first dual-energy dual-detector dental CBCT product that uses the dual-energy imaging technique, small-focus high-power X-ray tube head, and high-resolution detector to enhance spatial resolution and can not only meet oral and maxillofacial imaging needs but also provide X-ray cone beam computed tomography of ENT diseases.

Rocketheart Technology: China’s first implantable left ventricular assist system using the magnetic fluid suspension technology
The “implantable left ventricular assist system” produced by Rocketheart Technology Co., Ltd. is used with specific artificial blood vessels to provide mechanical support for blood circulation in patients with progressive refractory left heart failure and is also used as a bridge to heart transplantation or restoration of heart function. It is for use in medical institutions eligible for heart transplantation and able to provide comprehensive post-operative care and requires corresponding training passed by medical personnel, out-of-hospital caregivers, and patients. It is contraindicated in patients who are intolerant to anticoagulation therapy.

The product has core technologies with independent intellectual property such as integrated pump-motor design, magnetic fluid levitation, internal flow channel optimization, and dual redundancy of actuation, and is China’s first implantable left ventricular assist system using the magnetic fluid suspension technology, with key technical indicators reaching international levels.

Our United Corporation: China’s first image-guided Gamma Knife stereotactic radiosurgery instrument
The “Gamma Knife stereotactic radiosurgery system” produced by Our United Corporation is used for image-guided stereotactic head radiotherapy, radiosurgery, and stereotactic body radiotherapy for solid tumors and lesions. The product integrates kV CBCT image guidance technology and orthogonal imaging-based real-time image guidance technology, in which the company has independent intellectual property, and is China’s first image-guided Gamma Knife stereotactic radiosurgery instrument.

Venus Medtech: A new treatment option for severe pulmonary regurgitation
The innovative product “VenusP-Valve” of Venus Medtech (Hangzhou) Inc. includes a pulmonary valve and a delivery system. The pulmonary valve consists of a self-expanding nickel-titanium alloy stent, porcine pericardium leaflets, a skirt, and sutures. The pulmonary valve is designed to make valve stent anchorage more stable, apply to patients with a wider range of pulmonary valve annuli of different anatomic morphology, and realize safer stent delivery and smoother blood flow. The delivery system is designed to make the valve compressed uniformly and consistently, which increases loading efficiency and reduces the risk of radial folding during valve release.

The product is for postoperative congenital heart disease patients (age ≥ 12 years old, weight ≥ 30 kg) with severe pulmonary regurgitation (≥3+) and an autologous right ventricular outflow tract who also need to meet certain clinical conditions for use (see the product’s scope of application for details). It is understood that the product will offer a new treatment option to patients after marketing.




Source: Joinchain (excerpts)



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