Lunit secures FDA nod for AI-powered 3D breast tomosynthesis solution

Lunit, a leader in AI-powered cancer diagnostics, has achieved a significant milestone by securing U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT. This accomplishment not only marks a crucial advance in the ongoing battle against breast cancer but also opens the doors for Lunit to enter the U.S. breast screening market comprehensively.

Lunit INSIGHT DBT is an innovative AI algorithm specifically engineered to analyse 3D images generated by DBT equipment, offering a faster and more accurate breast cancer diagnosis compared to traditional 2D mammography screenings.

The demand for DBT technology is notably high, particularly among advanced medical institutions in the U.S., which account for over 64% of the global demand for DBT. As of November 2023, an impressive 88% of the total 8,850 facilities in the U.S., certified by the Mammography Quality Standards Act and Program (MQSA), are equipped with certified units featuring DBT technology.

Brandon Suh, the CEO of Lunit, emphasised the substantial influence of the U.S. in the global breast screening market, representing 40% of the market share and conducting over 40 million mammography screenings annually. Achieving FDA clearance for Lunit INSIGHT DBT not only strengthens their position in the largest market but also signifies a pivotal milestone in their overarching mission to revolutionise breast cancer diagnosis and save more lives.

This latest FDA clearance builds on Lunit's previous successes, including FDA clearance in November 2021 for its chest X-ray triage solution, 'Lunit INSIGHT CXR Triage,' and its AI-powered mammography analysis solution, 'Lunit INSIGHT MMG.' Additionally, Lunit INSIGHT DBT received clearance for Europe through CE marking under Europe's latest Medical Device Regulation (EU MDR) in March 2023.