FDA Clears Lunit's AI-Powered Digital Breast Tomosynthesis Platform
Lunit Insight DBT may facilitate improved detection and efficiency for radiologists interpreting digital breast tomosynthesis images.
The Food and Drug Administration (FDA) has granted 510(k) clearance for Lunit Insight DBT, an artificial intelligence (AI)-enabled modality that provides adjunctive assessment of digital breast tomosynthesis (DBT) images.
Using abnormality scores to quantify the malignancy likelihood of suspicious breast lesions, Lunit Insight DBT also provides information on lesion calcification and different types of soft tissue lesions, according to Lunit, the manufacturer of the modality.
In addition to enhanced visibility of highlighted lesions, Lunit emphasized that Lunit Insight DBT facilitates timely image assessment by enabling radiologists to jump to the most optimal 3D slice for viewing a suspicious lesion.
“More than 40 million mammography screenings are reported in the US annually. … Achieving FDA clearance for Lunit Insight DBT … marks a significant milestone in our mission to revolutionize breast cancer diagnosis and, ultimately, save more lives,” noted Brandon Suh, the CEO of Lunit.
BrightHeart Garners Third FDA Clearance for AI-Powered Assessments of Fetal Heart Ultrasound
May 14th 2025The latest FDA 510(k) clearance is for B-Right Views, an AI-enabled device, which provides automated detection of required views necessary for second- and third-trimester fetal heart ultrasound exams.
