HeartFocus
Overview
HeartFocus is an FDA-cleared, AI-powered cardiac ultrasound app that empowers any healthcare professional to capture clinical-grade heart scans after just hours of training. It provides real-time, on-screen prompts and a patented 3D guidance system to help users position the probe and acquire all 10 standard cardiac views with confidence. The software automatically records optimal clips when diagnostic quality is reached, reducing user variability and cognitive load. HeartFocus is clinically validated through international trials, demonstrating that novice users can acquire diagnostic-quality echocardiographic views. It supports DICOM-based integration with PACS for secure transfer and archival of scans.
HeartFocus is designed to address the shortage of cardiologists and expert sonographers, making cardiac imaging more accessible in various care settings, including primary care, emergency departments, rural clinics, and educational institutions. The company also offers HeartFocus Link, which extends AI-guided cardiac ultrasound learning and real-time quality feedback to existing cart-based ultrasound systems.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Live AI Guidance for probe positioning
- Diagnostic-quality view detection
- Auto-record for hands-free capture of optimal clips
- Real-time quality scoring and feedback
- Patented 3D Guidance System
- On-Image, Semi-Transparent Visual Cues
- DICOM-based integration with PACS
- Compatibility with Butterfly iQ+ and iQ3 ultrasound probes
- Offline scanning and AI guidance
- POCUS HeartFocus Certification Program
Use Cases
- Cardiac ultrasound acquisition by novice users
- Pre-screening for murmurs, suspected dysfunction, or risk stratification
- Follow-up imaging for congestive heart failure or cardiomyopathy
- Post-discharge monitoring in clinics or home settings
- Emergency department chest pain triage and hypotension assessment
- Medical education and training for cardiac ultrasound
Details
| Category | N/A |
| Pricing | Contact for pricing — 1 license per probe, unlimited users; 1-month free trial available |
| Deployment | Mobile app (iOS) and plug-in for cart-based ultrasound systems |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated HeartFocus received FDA 510(k) clearance on April 15, 2025, for its AI-enabled heart exam software, allowing healthcare professionals to perform clinical-quality heart scans. The FDA also approved DESKi's Predetermined Change Control Plan (PCCP) for HeartFocus, allowing for faster collaboration with other ultrasound systems. |
| Integrations | |
| EHR | Not specified |
| Specialties | All specialties |
What the Web Says
HeartFocus is an FDA-cleared, AI-powered cardiac ultrasound software designed to help healthcare professionals, including those with no prior ultrasound experience, acquire diagnostic-quality echocardiograms. It provides real-time guidance, automated view detection, and hands-free clip capture, aiming to address the shortage of cardiologists and expert sonographers and improve access to cardiac imaging. Clinical trials have shown that novice users guided by HeartFocus can achieve diagnostic-quality scans comparable to those performed by expert sonographers.
Overall: PositiveStrengths
- Enables novice healthcare professionals to perform diagnostic-quality echocardiograms with minimal training.
- Provides real-time AI guidance and continuous probe-positioning cues.
- Automatically records optimal diagnostic-quality clips, reducing user variability and cognitive load.
- Clinically validated through international trials, demonstrating high agreement with expert assessments.
- Expands access to high-quality cardiac imaging in various settings, including primary care, emergency, and rural clinics.
- Built with an advanced, medically validated cybersecurity framework that meets and exceeds regulatory expectations.
Limitations
- HeartFocus Link, which connects to existing ultrasound machines, provides AI guidance as an overlay and cannot access or process raw ultrasound data, potentially limiting the depth of analysis compared to fully integrated solutions.
- The company's funding is modest relative to the scale of the problem it is addressing.
- No direct patient benefit from a medical point of view for patients included in the initial analysis.
- Limited public reviews from G2, Capterra, or Reddit, making it difficult to gauge widespread user sentiment outside of clinical studies and official announcements.
Based on reviews from: Artificial Intelligence and Digital Technology in Cardiovascular Imaging: A Narrative Review, FDA Grants Clearance for AI-powered Cardiac Imaging Software | DAIC, HeartFocus Link adds AI cardiac imaging to any hospital ultrasound machine with a tablet and an HDMI cable - TNW, HeartFocus Product | AI-Powered Cardiac Ultrasound for Clinicians, Long School of Medicine - UT Health San Antonio, ACC.25 Science Presents New Applications For AI in the Clinical Setting, ClinicalTrials.gov, accessdata.fda.gov, Reddit, G2, Innolitics, ReachMD, GitHub, Xceed Imagination, Scouts by Yutori, Tracxn Feed Report - 07 Jan 2026 | PDF - Scribd
Last updated: 2026-09-23
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