OverviewHeartFocus is an FDA-cleared, AI-powered cardiac ultrasound application for mobile and tablet platforms that enables clinicians and care teams to capture diagnostic echocardiographic views with minimal training. The solution provides on-image, real-time guidance, automated capture when quality criteria are met, and quantitative feedback to standardize image acquisition across care settings.
Core capabilities- AI-guided, real-time probe guidance to achieve standard echocardiographic views.
- Patented 3D guidance system offering multi-planar probe positioning rather than simple directional cues.
- On-image semi-transparent AI overlay superimposed on the live ultrasound image to reduce eye movement and cognitive load.
- Auto-recording for hands-free capture once diagnostic-quality criteria are satisfied.
- Real-time quality indicator showing a percentage score for captured views.
- Dynamic example clips of echo views to demonstrate target motion and support pattern recognition during training.
- Single-side schematic overlay to provide reference anatomy while minimizing image distraction.
Clinical validation and outcomesHeartFocus has been validated in international clinical trials and peer-reviewed studies (publication reported in JACC: Advances). Evidence indicates novice users can acquire the standard set of echocardiographic views with diagnostic quality using HeartFocus. Key reported outcomes include high acquisition rates by non-expert operators, very high AI specificity (>99%), and rapid confidence gains after a small number of practice acquisitions (~9 acquisitions reported).
Deployment & integrationHeartFocus supports DICOM-compatible integration with PACS, HIPAA-compliant workflows, and is FDA-cleared for clinical use in the United States. The solution is delivered as a mobile/tablet application and can be deployed across environments from emergency departments and acute care to primary care clinics, rural health settings, cardiology services, and educational programs. A variant, HeartFocus Link, provides a plug-in AI integration for existing cart-based ultrasound systems and workflows.
Use cases & target users- Primary care clinicians: incorporate focused cardiac imaging into routine visits.
- Acute care / Emergency: rapid cardiac assessment when time is critical.
- Cardiology services: scale access to basic cardiac imaging and optimize specialist time.
- Education & training programs: accelerate ultrasound competency and enable objective competency assessment.
Publications & certificationHeartFocus is supported by peer-reviewed publications and documented clinical trial results. The company runs certification and training programs (POCUS HeartFocus Certification) to validate operator competency in cardiac image acquisition.
Technical specifications- Regulatory status: FDA-cleared for clinical use (United States).
- Integrations: DICOM-compatible; PACS integration supported.
- Privacy & security: supports HIPAA-compliant workflows.
- Acquisition features: live AI guidance, patented 3D probe guidance, semi-transparent on-image overlay, single-side schematic, auto-recording, percentage quality score indicator.
- Training outcomes (reported): novice users able to obtain diagnostic-quality images across standard views; rapid skill gain (confidence after approximately 9 practice acquisitions); reported high AI specificity (>99%).
- Form factor: mobile/tablet application with plug-in variant (HeartFocus Link) for cart-based ultrasound systems.
- Evidence: peer-reviewed study (JACC: Advances) and international clinical trials across academic centers, clinics, and hospitals.