- AI
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- Mammography
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.
Can AI Bolster Breast Cancer Detection in DBT Screening?
January 16th 2025In sequential breast cancer screening with digital breast tomosynthesis (DBT), true positive examinations had more than double the AI case score of true negative examinations and the highest positive AI score changes from previous exams, according to new research.
Multicenter Study Shows Merits of AI-Powered Ultrasound Assessment for Detecting Ovarian Cancer
January 3rd 2025Adjunctive AI offered greater than seven percent increases in sensitivity, specificity, and accuracy for ultrasound detection of ovarian cancer in comparison to unassisted clinicians who lacked ultrasound expertise, according to findings from new international multicenter research.
