Sam Brusco, Associate Editor11.14.23
Lunit, a provider of artificial intelligence (AI)-powered solutions for cancer diagnostics and therapeutics, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3D breast tomosynthesis (DBT) AI solution, Insight DBT.
Insight DBT is an AI algorithm that analyzes 3D images generated by DBT machines. The company said DBT imaging can provide faster, more accurate breast cancer diagnosis compared to 2D mammography screenings.
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.
"The U.S. 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," Lunit CEO Brandon Suh told the press. "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."
This clearance follows the company’s November 2021 FDA nod for its chest X-ray triage tool Insight CXR Triago, as well as its AI-powered mammography analysis solution Insight MMG.
Insight DBT is an AI algorithm that analyzes 3D images generated by DBT machines. The company said DBT imaging can provide faster, more accurate breast cancer diagnosis compared to 2D mammography screenings.
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.
"The U.S. 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," Lunit CEO Brandon Suh told the press. "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."
This clearance follows the company’s November 2021 FDA nod for its chest X-ray triage tool Insight CXR Triago, as well as its AI-powered mammography analysis solution Insight MMG.