Highwise Intelligence's AI-Assisted Diagnostic Product 'EndoFrame' Enters NMPA Innovative Medical Device Fast-Track Program
It has recently been learned that Huiwei Intelligence has officially received notification from the National Medical Products Administration (NMPA) that its submitted product, the “Software for Assisted Diagnosis of Colonic Polyps in Digestive Endoscopy,” known as the digestive endoscopy “FrameDetect,” has passed the special review procedure for innovative medical devices, thereby entering the “Innovation Channel.”
The “Innovation Channel” is a key supportive measure encouraged and promoted by the National Medical Products Administration (NMPA) to foster research and innovation in China’s medical device sector. “Innovation” and “expedited review” are the defining features of this channel. “Innovation” refers to the essential criteria for entry: the product’s core technology must be a domestic first and internationally leading, with fundamental improvements in performance or safety compared to similar products, and it must demonstrate significant clinical value. Applicants must legally hold patent rights for the product’s core technology. Products and related documentation undergo rigorous review by a panel of authoritative experts in the field. “Expedited review” means that entering the Innovation Channel can significantly accelerate the approval process for medical devices. With approximately 8,000 medical devices registered annually in China, waiting times for registration can be lengthy. The Innovation Channel is therefore of great significance to medical device companies, as it can substantially shorten time-to-market. Once a product enters the Innovation Channel, relevant authorities provide priority review and approval through early intervention, dedicated personnel, and comprehensive guidance, without lowering standards or reducing procedural requirements. This approach greatly shortens the registration cycle for Class III medical devices and accelerates product commercialization.
Although the “Innovation Channel” offers numerous benefits, products that truly qualify as “innovative” are exceedingly rare, and gaining access is highly challenging. As of January 2021, there were nearly 800,000 medical device distributors in China, yet fewer than 0.2% of these companies applied for the “Innovation Channel.” Official statistics show that over the seven years since the launch of the Special Approval Procedure for Innovative Medical Devices in 2014, fewer than 2,000 products have applied for entry into the “Innovation Channel,” with only approximately 20% of these applicants being accepted.
The inclusion of the digestive endoscopy “Frame Explorer” in the “Innovation Channel” marks a milestone event for Huiwei Intelligence, carrying significant strategic importance. Achieving such success within less than three years of its establishment not only demonstrates the recognition by national authoritative departments and experts of Huiwei Intelligence’s product and technological innovation capabilities, but also serves as an important indicator that its business direction of “AI-assisted diagnosis for dynamic medical imaging” has gained widespread acceptance.
Huiwei Intelligence will leverage its technological advantages in “artificial intelligence,” “edge computing,” and “integration of medicine and engineering” to continuously refine and advance its offerings, providing clinicians across more hospital departments with intelligent auxiliary diagnostic products and services that deliver “high standards, superior user experience, and low cost.”
Huiwei Intelligent Medical Technology Co., Ltd. was established in June 2019, specializing in the research and development, manufacturing, and sales of intelligent medical products. Our core team members hail from top-tier global research institutions and Fortune 500 companies. Driven by proprietary core technologies in the fields of “Artificial Intelligence” and “Edge Computing,” Huiwei Intelligent is committed to providing healthcare institutions worldwide with high-quality, user-friendly medical products and services, thereby maximizing assistance to physicians in enhancing diagnostic and therapeutic standards and efficiency.