Lunit, a medical AI company, said it has recorded its first sales in the U.S., just two months after obtaining approval from the U.S. FDA for Lunit INSIGHT DBT, its 3D breast cancer detection artificial intelligence (AI) solution, in November 2023.

The company stressed that this achievement marks a significant milestone, as it is the first time a locally developed 3D breast cancer detection AI solution has gained FDA approval.

Lunit will supply Lunit INSIGHT DBT and Lunit INSIGHT MMG to Mosaic Breast Imaging (MBI), a specialized breast medical clinic in Knoxville, Tennessee, for one year.

According to Lunit, MBI is renowned for creating patient-centered diagnostic environments and offering a broad spectrum of imaging diagnostic services. The clinic plans to use Lunit's solutions to provide patients with more accurate diagnoses of breast disease and increase diagnostic efficiency for healthcare providers.

"Computer-aided cancer diagnosis has been limited in its efficacy and usefulness in real-world clinical settings, but Lunit is leading the way in this area," MBI Director David Forsberg said. "Cancer diagnosis using AI will play an important role in detecting more breast cancers and, consequently, saving more lives from breast cancer."

Lunit CEO Suh Beom-suk also said, "It is very encouraging that a breast imaging center in the U.S., which has a well-developed 3D breast cancer screening environment with high expertise in medical technology and medical equipment, has chosen Lunit's freshly FDA-cleared product."

This supply agreement is the first step for Lunit to enter the U.S. market with Lunit Insight DBT, and the company will focus on expanding the U.S. business and strengthening its sales force in earnest this year, Seo added.