Lunit said on the 8th that it has applied to the U.S. Food and Drug Administration (FDA) for 510(k) premarket clearance of its breast cancer risk prediction solution, Lunit INSIGHT Risk. It aims to obtain clearance next year.
The 510(k) is a system that certifies that a medical device has efficacy and safety equivalent to or greater than an already marketed device.
Lunit INSIGHT Risk is AI software that predicts the likelihood of developing breast cancer within five years using only mammography images. It calculates each person's absolute risk using only the patient's image and age. Existing risk assessment models have been criticized for requiring complex questionnaires on physical information such as family history, height, age at menarche, and number of births, as well as lifestyle, and for having low accuracy.
The technology was designated a Breakthrough Device by the FDA in April, and Lunit has participated in the FDA's Total Product Life Cycle Advisory Program (TAP) to review its clearance strategy and development tasks in advance.
Lunit first unveiled the solution at the Radiological Society of North America (RSNA 2024) last year and said it planned to apply for FDA clearance in 2025. With this 510(k) submission, the company has begun the regulatory process for a North American launch as planned. The company aims to obtain clearance next year.
If it receives FDA clearance, the company will be able to build a full-cycle breast cancer care platform that connects breast cancer diagnosis–risk prediction–follow-up management in one, alongside existing products Lunit INSIGHT MMG and Lunit INSIGHT DBT.
Seo Beom-seok, CEO of Lunit, said, "Lunit INSIGHT Risk is a product based on a validated risk prediction solution created by the foremost authorities in the field of breast cancer," and added, "With this application, we will build an AI ecosystem that redefines the paradigm of breast cancer screening."