Recently, the National Medical Products Administration approved the registration applications for four innovative products: Changsha Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as "Changsha Huiwei Intelligent")'s "Intestinal Polyp Electronic Lower Digestive Endoscopy Image Assisted Detection Software", Shanghai Minimally Invasive Melody Medical Technology Co., Ltd. (hereinafter referred to as "Minimally Invasive Melody")'s "Spinning Intervention Therapy Device" and "Disposable Coronary Spinning Grinding Catheter", and Hunan Aptech Medical Equipment Co., Ltd. (hereinafter referred to as "Aptech Medical")'s "Disposable Magnetoelectric Positioning Pressure Monitoring Pulse Electric Field Ablation Catheter".

 Changsha Huiwei Intelligence, another heavyweight product approved
Changsha Huiwei Intelligent was established in 2020 and is a wholly-owned subsidiary of Suzhou Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as "Huiwei Intelligent"). Huiwei Intelligent was established in June 2019, specializing in the research and development, production, and sales of intelligent medical products. Driven by independent core technologies in the fields of "artificial intelligence" and "edge computing", the company is committed to providing medical products and services of "high standard and good experience" for global medical institutions, and helping doctors to improve their diagnosis and treatment level and efficiency to the greatest extent.

In mid-2021, Huiwei Intelligent's AI assisted detection system for gastrointestinal lesions - Endoscopic "Frame Probe" - was officially launched. This product can achieve full functional coverage of upper and lower gastrointestinal lesion detection. Through high-quality algorithms and computing power, it assists in detection and lesion classification, and automatically identifies, labels, and prompts lesions during endoscopic examination and surgery, with extremely high sensitivity and specificity.

In addition, another product of Huiwei Intelligence, the fundus screening product - "fundus Huitan", has also received high praise. Its portable DR fundus screening AI product overcomes many difficulties in the entry of AI screening equipment into the grassroots. The device is lightweight, mobile, has strong software compatibility, superior performance, comprehensive functions, fast computing speed, and controllable dependence on cloud platforms and networks.
In addition to endoscopic assisted diagnosis and treatment solutions and ophthalmic assisted diagnosis and treatment systems, relying on the strong research and development capabilities of the team, Huiwei Intelligence has mature solutions for other diseases, including lung disease assisted diagnosis and treatment products, rehabilitation and elderly care AI products, etc.

The electronic lower gastrointestinal endoscopic image assisted detection software for intestinal polyps, which has been approved for market this time, is installed and used in a single USB drive. It consists of a user module, a management module, an image acquisition and display module, an area acquisition control module, an automatic identification module, an algorithm module, and a basic module. It is mainly used for adult colonoscopy examination.

Moreover, the product adopts a dual stream fusion deep convolutional neural network algorithm, which can achieve real-time display of dynamic information during the surgical process. It has the advantages of low latency and high accuracy, and can provide patients with more efficient and high-quality auxiliary detection services.

 Minimally invasive melody, filling the domestic gap
Minimally Invasive Melody is a subsidiary of Shanghai Minimally Invasive Medical Equipment (Group) Co., Ltd., a subsidiary of Minimally Invasive Medical Science Co., Ltd. It is an enterprise mainly engaged in technology promotion and application services, independent from the field of minimally invasive coronary arteries, dedicated to the research and development of three types of active coronary medical devices. At present, many products under research are domestic innovative coronary medical devices, breaking the market monopoly of foreign products, and achieving better performance and better therapeutic effect with high-tech product working principle.

In coronary intervention therapy, severe coronary artery calcification has a significant impact on the success rate of surgery and patient prognosis. Faced with hard calcified lesions, rotational grinding pretreatment can help open the lumen and modify the calcified lesions, facilitating subsequent instrument passage and stent expansion and adhesion.

Minimally invasive melody ™ The coronary artery rotation grinding system fills the gap in the field of rotation grinding for domestic instruments. It features the first eccentric structure rotation grinding head design in China, which can adjust the rotation speed to change the centrifugal force during use, thereby controlling the rotation grinding diameter and reducing the need for instrument replacement during surgery, resulting in better tube cavity modification effects. At the same time, the entire surface of the grinding head is covered with diamond, allowing for bi-directional rotational grinding in the axial direction, reducing the risk of grinding head misalignment.

In terms of appearance, the product's thruster adopts a unique butterfly tail design, which increases the contact area and makes it more stable to place. At the same time, the semi transparent material makes the visual experience of the product softer, and the overall system color uses the Blue Crane series, which represents the feeling of "healing". In terms of control, the product adopts a highly integrated and portable design concept, making it more convenient for clinical applications.

At the beginning of this year, this coronary spiral grinding system won two heavyweight awards in the design industry: the "Red Dot Product Design Award" and the "iF Design Award". In September, it also won the "Shanghai Design 100+" award, once again demonstrating minimally invasive technology ® Strong capabilities in innovative research and industrial design. After being approved for listing, FireRaptor ® The coronary spiral grinding system will work together with the spinous process balloon and coronary impact waveguide system to jointly construct a solution for high resistance coronary artery lesions, providing a powerful pre-processing tool for the majority of coronary intervention doctors.

 Epert Medical focuses on minimally invasive interventions in the field of cardiovascular and cerebrovascular diseases
Epert Medical was founded in 2006 and is a wholly-owned subsidiary of Huitai Medical. It is a high-tech enterprise specializing in the research, development, production, and sales of cardiac electrophysiology and interventional medical devices. It has formed a business layout with complete coronary access and cardiac electrophysiology medical devices as the main focus, and peripheral vascular and neural interventional medical devices as the key development direction.
Since its establishment, Epert Medical has been committed to independent innovation and development in the field of minimally invasive cardiovascular and cerebrovascular interventions, and will make outstanding contributions to promoting the development of the global medical industry. More than 20 products have been developed and applied for the diagnosis and treatment of cardiovascular diseases, including hemostatic valve catheter sheaths, atrial septal puncture systems, ultra smooth contrast catheters, distal protectors, AAA/TAA stents, PTCA balloon catheters, microcatheters, guide catheters, guide extension catheters, blood flow reconstruction devices, and thrombectomy devices for the treatment of cerebrovascular diseases.

The disposable magnetic electric positioning pressure monitoring pulse electric field ablation catheter approved for listing this time consists of a head end, tube body, handle, connecting cable, and photoelectric hybrid plug, and is used in conjunction with the cardiac pulse electric field ablation device of Shanghai Hongtong Industrial Co., Ltd.

Shanghai Hongtong's heart pulse electric field ablation device has also been approved for market recently. The product consists of a host, an isolated power supply, a foot switch, and accessory cables. The accessory cables include: 3D positioning device connection cable, serial computer interface cable, impedance monitoring connection cable, and grounding cable. This product is used in conjunction with disposable pulsed electric field ablation catheters and is mainly used for the treatment of atrial fibrillation.

Moreover, the product adopts pulsed electric field ablation technology, which selectively treats the tissue at the lesion site by controlling the energy of the pulsed electric field, causing irreversible electroporation damage to myocardial cells, thus achieving the therapeutic goal. This technology can effectively reduce the risk of thermal damage to surrounding normal tissues, benefiting more patients with drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation.

Conclusion
Eight innovative medical products have been approved for market in December, and more and more domestic innovation forces are constantly emerging. Innovation, as the primary driving force, is continuously leading the continuous improvement of China's medical equipment level. With the acceleration of China's medical device innovation, more innovative products will emerge in the future, and the Chinese medical device industry is continuously accelerating towards the goal of high-quality development.

Source: https://news.yaozh.com/archive/44714.html