- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- 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.
Study Assesses Potential of Seven-Minute AI-Enhanced 3T MRI of the Shoulder
February 20th 2025Researchers found that the use of seven-minute threefold parallel imaging-accelerated deep learning 3T MRI had 89 percent sensitivity for supraspinatus-infraspinatus tendon tears and 93 percent sensitivity for superior labral tears.
Study: AI Boosts Ultrasound AUC for Predicting Thyroid Malignancy Risk by 34 Percent Over TI-RADS
February 17th 2025In a study involving assessment of over 1,000 thyroid nodules, researchers found the machine learning model led to substantial increases in sensitivity and specificity for estimating the risk of thyroid malignancy over traditional TI-RADS and guidelines from the American Thyroid Association.
