HeartFocus (V.1.1.1)
Overview
HeartFocus by Deski is an AI-enabled cardiac imaging software designed to democratize access to quality echocardiography. It empowers healthcare professionals, including those with limited prior ultrasound experience, to perform diagnostic-quality heart ultrasounds after a few hours of training. The software provides real-time AI guidance for probe positioning and automatically detects and records diagnostic-quality clips. It aims to address the critical shortage of trained sonographers and cardiologists, making early heart disease detection possible at the point of care in various settings, including primary care, rural clinics, and underserved communities. HeartFocus is available as an app or a software development kit (SDK) and integrates with compatible handheld, portable, and cart-based ultrasound devices.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-enabled real-time guidance for ultrasound probe positioning
- Automatic detection and recording of diagnostic-quality clips
- Empowers novice users to perform diagnostic-quality heart ultrasounds
- Compatible with handheld, portable, and cart-based ultrasound devices
- Supports acquisition of 10 standard echocardiographic views
- Available as an app or Software Development Kit (SDK)
- POCUS HeartFocus Certification program available
- Training resource for medical teachers and ultrasound competencies
- Clinically proven through international trials
Use Cases
- Early heart disease detection at the point of care
- Expanding access to cardiac care in primary care and rural settings
- Empowering non-specialist healthcare workers (nurses, assistants) to perform cardiac ultrasounds
- Training and education for ultrasound competencies
- Managing high patient volumes and extending cardiology services
- Facilitating cardiac evaluations in underserved communities
What Physicians Need to Know
HeartFocus empowers non-sonographer healthcare professionals (e.g., NPs, PAs, RNs, general practitioners, emergency doctors) to confidently acquire diagnostic-quality cardiac ultrasounds after minimal training, significantly expanding access to critical cardiac imaging in various settings, including rural clinics and emergency departments. This can streamline workflows, reduce the burden on cardiologists for routine scans, and facilitate earlier detection and ongoing monitoring of cardiac conditions like heart failure. The AI guidance and auto-recording features ensure consistent image quality, minimizing user variability and supporting reliable diagnostic assessments.
HeartFocus seamlessly integrates with existing healthcare infrastructure through DICOM-based transfer to PACS for direct upload and archival. It operates as an app on iOS iPads and is specifically compatible with Butterfly iQ+ and iQ3 handheld ultrasound probes. A key feature is its ability to function entirely offline, storing all patient data locally on the device, which enhances data security and ensures HIPAA-compliant workflows without reliance on cloud servers.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | App or SDK, integrated with compatible ultrasound devices (e.g., Butterfly Network's handheld ultrasound devices). |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated HeartFocus (V.1.1.1) received 510(k) clearance (K242807) from the U.S. Food and Drug Administration (FDA) on April 4, 2025, for image acquisition and/or optimization guided by artificial intelligence. The FDA also approved Deski's Predetermined Change Control Plan (PCCP) for HeartFocus. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Emergency Medicine, Radiology |
What the Web Says
HeartFocus (V.1.1.1) is an AI-powered software designed to guide healthcare professionals, including novices, in acquiring diagnostic-quality cardiac ultrasound images. It has undergone international clinical trials demonstrating its efficacy and has received FDA clearance with a Predetermined Change Control Plan (PCCP), allowing for ongoing updates to its AI algorithms. The software aims to address the shortage of cardiologists and sonographers by expanding access to cardiac imaging in various settings, from primary care to emergency departments.
Overall: PositiveStrengths
- Enables novice users to acquire diagnostic-quality echocardiograms after brief training.
- Provides real-time, on-screen guidance for probe positioning.
- Automatically records optimal clips when diagnostic quality is reached, reducing user variability.
- Supports DICOM-based integration with PACS for direct upload and archival.
- FDA-cleared with a Predetermined Change Control Plan (PCCP) for faster software updates.
- Designed with a robust, medically validated cybersecurity framework.
Limitations
- As an overlay system, it cannot access or process raw ultrasound data, potentially limiting the depth of AI analysis compared to fully integrated solutions.
- The company's funding is modest compared to the scale of the problem, which may impact its ability to compete with larger medical imaging companies.
- Relies on compatible general-purpose diagnostic ultrasound systems.
Based on reviews from: HeartFocus Product | AI-Powered Cardiac Ultrasound for Clinicians, HeartFocus Clinical Trial Proves AI Can Empower Novices to Deliver Diagnostic-Quality Cardiac Ultrasounds - HMP Global Learning Network, Democratizing Cardiac Care: How AI is Bridging the Specialist Gap, HeartFocus Link brings AI cardiac ultrasound to any cart system - TNW, FDA Grants Clearance for HeartFocus, the Transformative AI-powered Cardiac Imaging Software - Business Wire, Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics, K242807 - 510(k) Premarket Notification - FDA, 2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics, List of FDA authorized devices with Predetermined Change Control Plans
Last updated: 2026-07-19
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