Lunit Nets FDA Nod for AI-Powered 3D Breast Tomosynthesis Solution, Lunit INSIGHT DBT

November 14, 2023 |

3 min read

Lunit announced that it has received U.S. Food and Drug Administration 510 clearance for its 3D Breast Tomosynthesis AI solution, Lunit INSIGHT DBT.

Lunit INSIGHT DBT receives FDA 510(k) clearance, poised to enter the world’s largest DBT market

SEOUL, South Korea, Nov. 14, 2023 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D Breast Tomosynthesis (DBT) AI solution, Lunit INSIGHT DBT. This approval signifies a major step forward in the fight against breast cancer, enabling Lunit to make a full-fledged entry into the US breast screening market.

Lunit INSIGHT DBT is an AI algorithm engineered to analyze 3D images generated by DBT equipment. DBT imaging offers a faster and more accurate breast cancer diagnosis compared to traditional 2D mammography screenings.

With DBT’s capability to provide more precise breast cancer examinations, the demand for this technology is high, especially among advanced medical institutions in the US, which accounts for over 64% of the global demand for DBT. As of November 2023, 88% of the total 8,850 facilities in the US certified by the Mammography Quality Standards Act and Program (MQSA) are certified units with DBT.^{^[1]}

“The US is the biggest player in the global breast screening market, accounting for up to 40% of the market share. More than 40 million mammography screenings are reported in the US annually,” said Brandon Suh, CEO of Lunit. “Given this substantial market influence, achieving FDA clearance for Lunit INSIGHT DBT not only solidifies our presence in the largest market but also marks a significant milestone in our mission to revolutionize breast cancer diagnosis and, ultimately, save more lives.”

With this latest FDA clearance, Lunit continues its journey to bring groundbreaking AI breast imaging to the forefront of cancer diagnosis, promising a future where early detection and treatment of breast cancer becomes more accessible and accurate.

This FDA clearance follows Lunit’s previous achievements in November 2021, when it received FDA clearance for its chest X-ray triage solution ‘Lunit INSIGHT CXR Triage’ and for its AI-powered mammography analysis solution ‘Lunit INSIGHT MMG.’ In addition, Lunit INSIGHT DBT has been cleared for Europe by being CE-marked under Europe’s latest Medical Device Regulation (EU MDR) since March 2023.

About Lunit

Lunit is a deep learning-based medical AI company on a mission to conquer cancer. Our focus is on developing AI solutions for precision diagnostics and therapeutics, ensuring the right diagnosis, and treatment, at the right cost for each patient. Lunit is devoted to developing advanced medical image analytics and AI-based biomarkers via cutting-edge technology.

Founded in 2013, Lunit has been acknowledged around the world for its advanced, state-of-the-art technology and its application in medical images. As a medical AI company grounded on clinical evidence, the company’s findings are presented in major peer-reviewed journals, such as the Journal of Clinical Oncology and the Lancet Digital Health, and global conferences, including ASCO and RSNA.

After receiving FDA clearance and the CE Mark, our flagship Lunit INSIGHT suite is clinically used in approximately 2,000+ hospitals and medical institutions across 40+ countries. Lunit is headquartered in Seoul, South Korea, with offices and representatives worldwide. For more information, please visit lunit.io.

^{^[1]} MQSA National Statistics: https://www.fda.gov/radiation-emitting-products/mqsa-insights/mqsa-national-statistics