FDA Clears AI-Based HeartFocus Echo Software by DESKi
FDA Clears AI-Based HeartFocus Echo Software by DESKi
Source: Health Imaging / ACC.25 coverage
Date: April 2025 (specific article date not listed; data presented at ACC.25)
Take-Home Messages:
1. FDA Clearance:
• French medtech company DESKi received FDA clearance for its AI-powered echocardiography software HeartFocus.
• This approval enables the software to be used clinically in the United States.
2. Function & Purpose:
• HeartFocus is designed to help any healthcare professional, regardless of echo training, perform high-quality echocardiograms.
• It can be used with any type of ultrasound machine—big, small, or handheld—and it gives step-by-step instructions to help the user capture all the right heart images.
3. Clinical Need & Innovation:
• Addresses the global shortage of cardiologists and trained sonographers, especially in rural and underserved areas.
• The AI platform allows non-specialists to obtain diagnostic-quality echo images confidently.
4. Expert Endorsement:
It can be used with any type of ultrasound machine—big, small, or handheld—and it gives step-by-step instructions to help the user capture all the right heart images.
5. ACC.25 Data:
• Presented at ACC.25, the clinical trial included 200+ patients.
• Results showed that novice users using HeartFocus achieved echo quality comparable to expert cardiologists and sonographers.https://www.heartfocus.ai/?utm_source=chatgpt.com