World's First Dynamic Ultrasound Imaging AI Breast Cancer Diagnosis... BeamWorks Designated as Innovative Medical Device

Beamworx logo designated as an innovative medical device.

[Asia Economy Yeongnam Reporting Headquarters Reporter Gu Daeseon] Daegu City announced on the 7th that Beamworks (CEO Kim Wonhwa, radiologist at Chilgok Kyungpook National University Hospital), a promising medical device startup in the Daegu area, has developed the ultrasound breast cancer real-time AI diagnostic system ‘CadAI-B’, which has been designated as an innovative medical device by the Ministry of Food and Drug Safety (MFDS) for the first time in the Daegu region.

‘CadAI-B’ is the world’s first AI-based software medical device that diagnoses breast cancer using dynamic ultrasound images. It was recognized for its distinctiveness and excellence and was designated as an innovative medical device by the MFDS.

To overcome the drawback of conventional ultrasound examinations relying on the subjective judgment of doctors, which causes diagnostic variability depending on experience or expertise, CadAI-B utilizes over 500,000 ultrasound digital medical images of breast cancer patients and an optimized AI model to provide real-time reading images. This method establishes an objective and consistent diagnostic environment through AI, expected to contribute to advancing domestic medical technology to the next level.

When designated as an innovative medical device, special provisions apply such as priority review over other medical devices during approval or simultaneous review divided by development stages. After approval, it can be rapidly utilized in medical settings as non-reimbursed or selectively reimbursed, accelerating the dissemination of innovative technology and realization of sales.

Additionally, companies can receive certification as innovative medical device enterprises under the Medical Device Industry Act, enabling them to participate in government R&D and market entry support projects and receive various policy benefits.

The innovative medical device designation system was established in 2020 under the ‘Medical Device Industry Promotion and Innovative Medical Device Support Act’. It designates medical devices that significantly improve or are expected to improve safety and efficacy through the application of advanced technologies or improved usage methods in fields with high technology intensity and rapid innovation speed, based on an evaluation of conformity to designation criteria. Currently, 23 products nationwide have been designated as innovative medical devices.

Beamworks was founded in 2021 based on technology and experience accumulated through joint research by professors of medicine and computer engineering at Kyungpook National University. With government support such as promising technology startup support and Daegu City’s ‘Software Medical Device Specialized Support Project’, they succeeded in developing ‘CadAI-B’ and plan to obtain approval after clinical trials in the first half of next year.

Lee Seungdae, Director of Innovation Growth Office at Daegu City, said, “Starting with this innovative medical device designation, we will establish a systematic support system from R&D to investment attraction so that local medical companies’ products can be designated as innovative medical devices, and do our best to discover and nurture global leading companies.”