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.
Newsletter
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
Stroke MRI Study Assesses Impact of Motion Artifacts Upon AI and Radiologist Lesion Detection
July 16th 2025Noting a 7.4 percent incidence of motion artifacts on brain MRI scans for suspected stroke patients, the authors of a new study found that motion artifacts can reduce radiologist and AI accuracy for detecting hemorrhagic lesions.
