HeartLung Corporation's AI-CVD receives FDA clearance for opportunistic multi-condition screening on routine chest CT scans.
Key Details
- 1FDA grants 510(k) clearance to HeartLung Corporation's AI-CVD algorithm.
- 2AI-CVD performs 11 opportunistic screening assessments on chest CT scans.
- 3Assesses for findings like coronary calcium, valve and wall calcium, volumetry, lung and liver attenuation, bone mineral density, and more.
- 4Alerts doctors to incidental findings that may indicate risk for conditions such as heart disease, stroke, osteoporosis, diabetes, and liver steatosis.
- 5Can be used for both new and prior CT scans, supporting broader preventive care.
- 6Platform potentially applicable to nearly 40 million CT scans per year in the U.S.
Why It Matters
This clearance introduces the most comprehensive FDA-cleared AI platform for opportunistic screening on CT, enabling earlier identification of at-risk patients and broadening the utility of routine imaging for preventive care. Radiology practices may see an expanded role in population health management through automated, multi-disease detection.
Source
Cardiovascular Business
Related News
•Radiology Business
FDA Clears MRI2CT AI for 3D Bone Visualization from MRI
MRI2CT's NextMR receives FDA clearance to generate 3D bone images from standard spine MRIs, reducing reliance on CT scans.
•Radiology Business
FDA Clears AIRS Medical AI for Rapid MRI Body Composition Analysis
AIRS Medical's SwiftSight Body Composition AI software receives FDA 510(k) clearance for automated MRI-based body composition reporting.
•Radiology Business
Harrison.ai Cuts 15% Staff as Revenue and U.S. Expansion Accelerate
Radiology AI firm Harrison.ai reduces staffing by 15% amid quadrupling revenue and major U.S. expansion.