FDA Clears Emerging AI-Enabled Software for Cardiac Ultrasound
Recent research has demonstrated that the AI software HeartFocus enabled novice health-care providers to achieve greater than 85 percent agreement with expert sonographers in assessing echocardiographic parameters.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the AI-powered echocardiography HeartFocus software, which reportedly allows health-care providers with limited echocardiography experience to obtain heart scans.
In addition to offering quality and precision indicators via real-time feedback, the HeartFocus software provides automated recording of top quality clips for 10 ultrasound cardiac reference views, according to DESKi, the manufacturer of the software.
In research presented recently at the American College of Cardiology (ACC) conference, the newly FDA-cleared AI software HeartFocus enabled health-care providers with novice-level echocardiography experience to achieve greater than 85 percent agreement with expert assessment of echocardiographic parameters. (Image courtesy of DESKi.)
In a prospective multicenter trial, presented recently at the American College of Cardiology (ACC) conference, researchers found that health-care providers with limited echocardiography experience who used the HeartFocus software were able to achieve greater than 85 percent agreement with expert sonographers in assessing 12 echocardiographic parameters.
“The clinical trial results and subsequent FDA clearance mark a major step forward in making echocardiography more accessible in the community. Proving that it can successfully guide any healthcare professional to capture high-quality heart scans, HeartFocus will help patients get diagnosed sooner and move more quickly toward the treatment they need,” posited Varinder P. Singh, M.D., the chair of the Department of Cardiology at Lenox Hill Hospital in New York, and senior vice president and executive director of global and international health for Northwell Health.
Possible Real-Time Adaptive Approach to Breast MRI Suggests ‘New Era’ of AI-Directed MRI
June 3rd 2025Assessing the simulated use of AI-generated suspicion scores for determining whether one should continue with full MRI or shift to an abbreviated MRI, the authors of a new study noted comparable sensitivity, specificity, and positive predictive value for biopsies between the MRI approaches.
Mammography AI Platform for Five-Year Breast Cancer Risk Prediction Gets FDA De Novo Authorization
June 2nd 2025Through AI recognition of subtle patterns in breast tissue on screening mammograms, the Clairity Breast software reportedly provides validated risk scoring for predicting one’s five-year risk of breast cancer.
Lunit Unveils Enhanced AI-Powered CXR Software Update
May 28th 2025The Lunit Insight CXR4 update reportedly offers new features such as current-prior comparison of chest X-rays (CXRs), acute bone fracture detection and a 99.5 percent negative predictive value (NPV) for identifying normal CXRs.
