• 09 Jun 2025
• Admin
• News Article

HeartSciences receives US FDA BTD designation for its AI-ECG algorithm

"HeartSciences receives US FDA breakthrough device designation for its AI-ECG algorithm for detecting aortic stenosis

Overview

HeartSciences Inc, an artificial intelligence-powered medical technology company focused on advancing the capabilities of ECGs/EKGs for the earlier detection of heart disease, announced that the US Food and Drug Administration has granted Breakthrough Device designation for its Aortic Stenosis ECG algorithm.

About Aortic Stenosis

• Aortic Stenosis is one of the most serious and common heart valve diseases, often progressing silently and leading to severe, life-threatening outcomes if left undetected. 

• Early symptoms are frequently vague or absent, resulting in delayed diagnosis and treatment. 

• If unrecognized, Aortic Stenosis can cause irreversible myocardial damage and significant deterioration in cardiac function. 

• Aortic Stenosis is a serious and widespread condition. 

• The AI-ECG algorithm offers a powerful diagnostic solution designed for seamless integration with Hospital EHR systems.

AI ECG Tool for Aortic Stenosis Awaits FDA Clearance

• The algorithm would offer a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. 

• Once cleared by the US FDA, the algorithm will be accessible through HeartSciences’ MyoVista Insights cloud-based platform which would directly integrate with hospital electronic health record (EHR) systems, requiring no additional hardware or testing. 

Clinical Advantages

This technology provides several key clinical advantages:
• Detection in asymptomatic or under-evaluated patients who may not yet show signs of Aortic Stenosis. Real-time or retrospective analysis using existing ECG data already captured during routine care.
• Expanded access to early diagnosis, especially in underserved areas lacking specialized cardiac imaging or providers.

AI Algorithm Detects Aortic Stenosis early

• The algorithm was developed using advanced convolutional neural network deep learning techniques and trained on more than 120,000 ECG records. 

• In performance evaluations, it demonstrated the ability to detect aortic stenosis up to 24 months prior to confirmatory echocardiography, with diagnostic accuracy increasing as the disease progressed.

Benefits for this approval

• This breakthrough gives clinicians the ability to identify aortic valve disease earlier in its course, allowing for timely interventions and improved patient outcomes. 

• The AI-ECG algorithm was developed at the Icahn School of Medicine at Mount Sinai by Dr. Akhil Vaid.

Words from CEO: CEO of HeartSciences

• “Receiving US FDA Breakthrough Device Designation marks another significant milestone for HeartSciences,” said Andrew Simpson, CEO of HeartSciences. 

• “By combining the widespread accessibility of ECGs with the power of deep learning, our aortic stenosis algorithm has the potential to transform how this serious and often silent disease is detected - leading to earlier referrals, better treatment pathways, and ultimately, improved lives.”