UltraSight AI Guidance
AI-powered real-time guidance software for cardiac ultrasound image acquisition
Company profile
Company profile
UltraSight is a digital health pioneer transforming cardiac imaging through the power of artificial intelligence. The company's real-time AI guidance software enables medical professionals without sonography experience to acquire diagnostic-quality cardiac ultrasound images across multiple care settings, including emergency departments, clinics, community hospitals, ambulances, and remote areas. The platform pairs with point-of-care ultrasound devices and provides a graphic interface overlaid on the ultrasound screen, guiding users in real-time on how to maneuver the probe to obtain diagnostic quality images. UltraSight's technology addresses a critical healthcare gap: while over 8 million patients are admitted to U.S. emergency departments annually with symptoms concerning for heart attack or heart failure, and approximately 30 million heart disease patients require periodic cardiac monitoring, significant bottlenecks and limited training resources restrict access to timely cardiac ultrasound. The company's AI neural network predicts the position of the ultrasound probe relative to the heart based on the ultrasound video stream, providing three-dimensional guidance with precise magnitude of movement. Clinical studies demonstrate that after minimal training with the AI guidance software, novice users can acquire images of diagnostic quality approaching that of expert sonographers in 93-100% of patient exams. UltraSight has received FDA clearance and CE Marking, enabling deployment across healthcare systems, emergency medicine, out-of-hospital care, and critical care settings.
Company description UltraSight official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Embedded deployment with recorded integration context.
Recorded integration context: Philips Lumify Ultrasound System.
Company milestones
FDA clearance granted July 2023. Expanded FDA clearance received to work across ultrasound systems. New data presented at ACC 2025 and THT 2026. PVAD IQ product for critical care launched. Seeking clinical researchers for investigator-led research grants.
Partnerships
02 · Flagship portfolio
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AI-powered real-time guidance software for cardiac ultrasound image acquisition
AI-enabled imaging tool for bedside pump position assessment in critical care
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
European heart journal. Digital health · May 1, 2026
A view-flexible deep learning framework for automated analysis of 2D echocardiography.NPJ cardiovascular health · Apr 1, 2026
Snapshot artificial intelligence-determination of ejection fraction from a single frame still image: a multi-institutional, retrospective model development and validation study.The Lancet. Digital health · Apr 1, 2025
Real-Time Artificial Intelligence-Based Guidance of Echocardiographic Imaging by Novices: Image Quality and Suitability for Diagnostic Interpretation and Quantitative Analysis.Circulation. Cardiovascular imaging · Nov 1, 2023
Clinical validation
No linked records are currently available.
Regulatory
K252235 · 510k · Dec 18, 2025
UltraSight GuidanceK251416 · 510k · Dec 17, 2025
UltraSight AI GuidanceK223347 · 510k · Jul 24, 2023
04 · Company-reported outcomes
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Pivotal study results
Pivotal study results
Pivotal study results
Pivotal study results
Overall pivotal study performance
Multicenter pivotal study location for evaluating UltraSight AI guidance software in enabling non-experts to perform echocardiographic examinations
Demonstrated that novice users can acquire images of diagnostic quality approaching that of expert sonographers in the majority of patients
Multicenter pivotal study location in Israel for validating UltraSight's real-time guidance technology for cardiac ultrasound
Clinical interpretation was similar when exams were done by novice users using UltraSight's Real-Time Guidance software compared with sonographers
Multicenter pivotal study to evaluate AI guidance software's ability to enable medical professionals without echocardiography experience to acquire cardiac ultrasound images
Medical professionals without prior sonography experience acquired high quality diagnostic images in 93-100% of patient exams, with 99.2% sufficient quality for LV size, 99.6% for LV function, 92.9% for RV size, and 100% for pericardial effusion
05 · Leadership
Leadership profiles and professional links from the current Company record.
Davidi Vortman
CEO
Roberto Lang
Director of Cardiovascular Imaging (Clinical Advisor)
06 · Company updates
Recent articles published on UltraSight's official website.
07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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