Friday, February 23, 2024
Cleerly, a company pioneering a novel standard of care for diagnosing heart disease, has unveiled its latest achievement: the FDA-cleared Cleerly ISCHEMIA software. This innovative software, now approved by the U.S. Food and Drug Administration (FDA), can be utilized alongside non-invasive coronary CT angiograms (CCTA) and billed using the newly introduced Category I CPT code 75580.
According to the American Medical Association (AMA), this software is categorized as a complementary augmented intelligence tool. It aids healthcare professionals in estimating fractional flow reserve (FFR) non-invasively, thereby assisting in clinical diagnosis and decision-making processes.
Cleerly ISCHEMIA's capabilities extend to supporting both interpreting imaging physicians and treating physicians in their clinical assessments. By allowing detailed analysis of coronary lesions across all vessels, the software facilitates comprehensive mapping of anatomical and physiological findings related to coronary artery disease.
One of the key features of Cleerly ISCHEMIA is its ability to provide non-invasive estimates of FFR values, aligning with professional society guidelines. This feature helps healthcare professionals make critical decisions regarding the management of patients suspected of having coronary artery disease.
The software's design enables comprehensive mapping of both anatomical and physiological data for each coronary lesion throughout the entire vascular network. This holistic approach enhances understanding of pathology and aids in developing personalized treatment plans for patients.
Overall, Cleerly ISCHEMIA represents a significant advancement in cardiovascular diagnostics. It offers a non-invasive, comprehensive solution for evaluating coronary artery disease, with the potential to improve patient care and optimize treatment strategies.
Source: businesswire.com
