AccurKardia, a New York-based ECG company, has secured Breakthrough Device designation from the FDA for its AI-powered Aortic Valve Stenosis (AVS) screening software. Concurrently, iCardio.ai, based in Los Angeles, received FDA 510(k) clearance for its EchoMeasure software, which leverages AI for echocardiography interpretation.
AccurKardia's AI for Aortic Valve Stenosis Detection
AccurKardia's software is designed to analyze existing ECG records to identify potential AVS cases, a condition often underdiagnosed and life-threatening if untreated. The AI aims to prioritize patients for echocardiograms, enabling earlier diagnosis and intervention. According to AccurKardia, undetected AVS can lead to one-year mortality rates as high as 50%. The company's technology is particularly beneficial in regions with limited access to cardiology specialists and advanced imaging.
Juan C. Jimenez, co-founder and CEO of AccurKardia, stated, "Our mission is to improve patient outcomes and save lives by transforming ECG into a broad biomarker, with initial focus in cardiology. Our AVS detection technology is the first application of its kind in the detection of structural heart disease, where the condition is chronically underdiagnosed, has a high mortality rate, and can otherwise be treated successfully."
The Breakthrough Device designation will expedite the FDA review process for AccurKardia's AVS screening software, potentially leading to earlier market availability. The company also suggests that the AI-powered screening tool could reduce heart failure hospitalizations and save millions in healthcare costs.
iCardio.ai's AI for Echocardiography
iCardio.ai's EchoMeasure software has received FDA 510(k) clearance for its AI-driven interpretation of echocardiograms. The software supports a streamlined workflow for automated echocardiographic interpretation, serving as a foundation for future algorithms, particularly in structural heart disease detection. The company's algorithms can also detect valvular heart disease, attracting interest from health systems and prosthetic valve manufacturers.
In September, iCardio.ai partnered with Abbott to develop AI applications for Abbott's imaging devices, specifically automating model creation on the EnSiteX cardiac mapping system using 2D intracardiac echo (ICE) images captured by Abbott's ICE catheters. The same month, iCardio.ai joined the Cedars-Sinai Accelerator program and partnered with SAR MedIQ to accelerate the availability of AI in cloud PACS and the broader cardiology healthcare industry.
These FDA designations mark significant advancements in the use of AI for cardiac screening, with the potential to improve patient outcomes, reduce healthcare costs, and optimize resource utilization.
