- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
RadNet Subsidiary Captures Mammography AI FDA Clearance
AI-fueled mammography triage software from DeepHealth wins 510(k).
Artificial intelligence (AI) developer DeepHealth, a subsidiary of RadNet, announced Monday it has secured 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its mammography triage solution, Saige-Q.
This AI-driven screening worklist prioritization tool is DeepHealth’s first cleared product, and it automatically identifies screening exams that have suspicious findings that require additional evaluation, company officials said. By identifying these cases, the software helps radiologists streamline their workflow to be more efficient and effective.
“Saige-Q is built using our core artificial intelligence algorithms, described in a recent article in Nature Medicine,” said Bill Lotter, Ph.D., chief technology officer, and DeepHealth co-founder. “As the FDA-cleared mammography triage product that supports 3D mammography in addition to 2D mammography, Saige-Q demonstrates high performance that is maintained across different breast densities and lesion types.”
It is a tool that is designed to increase radiologist confidence in their ability to pinpoint suspicious findings, bolstering their ability to provide high-quality care.
For more coverage based on industry expert insights and research, subscribe to the Diagnostic Imaging e-Newsletter here.
Study for Emerging PET/CT Agent Reveals ‘New Standard’ for Detecting Clear Cell Renal Cell Carcinoma
September 11th 2024Results from a multicenter phase 3 trial showed that the PET/CT imaging agent (89Zr)Zr-girentuximab had an 85.5 percent mean sensitivity rate for the diagnosis of clear cell renal cell carcinoma.
Study Assesses Lung CT-Based AI Models for Predicting Interstitial Lung Abnormality
September 6th 2024A machine-learning-based model demonstrated an 87 percent area under the curve and a 90 percent specificity rate for predicting interstitial lung abnormality on CT scans, according to new research.
What a Prospective CT Study Reveals About Adjunctive AI for Triage of Intracranial Hemorrhages
September 4th 2024Adjunctive AI showed no difference in accuracy than unassisted radiologists for intracranial hemorrhage (ICH) detection and had a slightly longer mean report turnaround time for ICH-positive cases, according to newly published prospective research.
