Cardiac Ultrasound Update: FDA Clears Software with 45 Automated Parameters for Echocardiographic Analysis
Strain imaging analysis is one of the automated parameters included in the newly FDA-cleared Us2.v2 software for adjunctive review of echocardiographic images.
In what may provide a boost for streamlining cardiac ultrasound workflows, the Food and Drug Administration (FDA) has granted 510(k) clearance for the Us2.v2 software (Us2.ai), which reportedly provides 45 automated parameters for adjunctive assessment of echocardiographic images.
Key aspects of the Us2.v2 software include strain imaging assessment, regional strain analysis, aortic stenosis measurement as well as analysis of left and right atrial and ventricular linear dimensions, according to Us2.ai.
The newly FDA-cleared Us2.v2 software reportedly provides 45 automated parameters for adjunctive assessment of echocardiographic images. (Image courtesy of Us2.ai.)
Emphasizing that the software’s real-time automated capabilities reduce the variability that can occur with human assessment, Us2.ai said the Us2.v2 software also enhances workflow with explainable artificial intelligence (AI) output and streamlined reporting.
“By offering advanced capabilities that significantly enhance both precision and efficiency of echocardiographic analysis, this innovation dramatically reduces analysis time thereby speeding up clinical workflow. This is particularly helpful in clinical states that require additional imaging parameters such as strain, or are challenged by variability in interpretation such as aortic stenosis, said Madhav Swaminathan, M.D., a past president of the American Society of Echocardiography (ASE) and an associate professor of anesthesiology at Duke University Medical Center in Durham, N.C.
FDA Clears Ultrasound AI Detection for Pleural Effusion and Consolidation
June 18th 2025The 14th FDA-cleared AI software embedded in the Exo Iris ultrasound device reportedly enables automated detection of key pulmonary findings that may facilitate detection of pneumonia and tuberculosis in seconds.
Ultrasound-Guided Thermal Ablation Shows Low Recurrence of Thyroid Carcinoma at Five Years
June 16th 2025In a meta-analysis involving over 2,200 patients with T1NoMo papillary thyroid carcinoma, researchers noted 2 percent recurrence and no cases of lymph node metastasis five years after ultrasound-guided thermal ablation.
Multinational Study Reaffirms Value of Adjunctive AI for Prostate MRI
June 16th 2025The use of adjunctive AI in biparametric prostate MRI exams led to 3.3 percent and 3.4 percent increases in the AUC and specificity, respectively, for clinically significant prostate cancer (csPCa) in a 360-person cohort drawn from 53 facilities.
