UltraSight Guidance

by Ultrasight  · Based in United States → — AI-Powered Cardiac Ultrasound Guidance for Healthcare Professionals
Cardiology Critical Care Emergency Medicine
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Regulatory Status Disclosed

Overview

UltraSight Guidance is an innovative AI-driven software designed to empower healthcare professionals, regardless of their sonography experience, to acquire high-quality cardiac ultrasound images. The software provides real-time guidance and quality assessment, simplifying the complex process of echocardiography. By overlaying intuitive graphic instructions on the ultrasound screen, it guides users on probe positioning and movement in three dimensions (X, Y, and Z axes) to achieve diagnostic-quality images of 10 standard cardiac views. This technology aims to increase access to timely and accurate cardiac imaging in various care settings, from emergency departments and critical care units to out-of-hospital and remote locations, ultimately supporting faster diagnosis and improved patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time AI guidance for ultrasound probe positioning
  • Image quality assessment and feedback (Quality Bar)
  • View detection (No heart, Navigate, Hold position)
  • Guidance for 10 standard cardiac views (PLAX, PSAX-AV, PSAX-MV, PSAX-PM, AP4, AP5, AP2, AP3, SubC4, SC-IVC)
  • 3D guidance user interface (X, Y, Z axes)
  • Continuous real-time guidance and movement tracking
  • Magnitude of movement instructions
  • Compatibility with general-purpose diagnostic ultrasound systems (e.g., Philips Lumify, expanding to other handheld, laptop, and cart-based systems)
  • Tutorials for each view (depth, probe placement, marker direction)

Use Cases

  • Emergency medicine
  • Out-of-hospital care
  • Critical care
  • Screening for structural heart disease
  • Early detection of Stage B heart failure
  • Cardiac monitoring for chronic heart disease patients

What Physicians Need to Know

Echocardiography AI Features
UltraSight Guidance provides real-time AI-driven guidance for acquiring 10 standard cardiac ultrasound views, including Parasternal Long-Axis, Parasternal Short-Axis (at Aortic Valve, Mitral Valve, Papillary Muscle), Apical (4-Chamber, 5-Chamber, 2-Chamber, 3-Chamber), and Subcostal (4-Chamber, Inferior Vena Cava). It offers a 3D guidance user interface with continuous real-time feedback on probe position and movement (X, Y, and Z axes) and magnitude, helping users achieve diagnostic-quality images. The system includes an image quality bar that continuously updates, instructing users to capture images once a quality threshold is met. Studies show that novice users, after minimal training, can acquire diagnostic-quality images comparable to expert sonographers, with high interpretability and accuracy for various cardiac assessments.
Heart Failure Risk Prediction
The AI platform has demonstrated potential in the early detection of Stage B heart failure, with a 95% negative predictive value for identifying patients with Left Ventricular Ejection Fraction (LVEF) below 50%. It also shows 100% sensitivity for detecting LVEF below 40% in cardio-oncology patients, with 98.8% agreement with expert echocardiography. Additionally, a deep learning model can estimate Left Ventricular Enlargement (LVE) from novice-acquired scans with diagnostic accuracy equivalent to expert interpretation.
Cardiac Monitoring Integration
UltraSight's Real-Time Guidance software is designed to optimize and streamline cardiac monitoring and other clinical workflows, enabling non-sonographers to achieve consistent, diagnostic-quality ultrasound. It supports timely diagnoses, more efficient workflows, and scalable cardiovascular screening strategies. The PVAD IQ tool, integrated with the UltraSight Echosystem, is an FDA-cleared, AI-enabled imaging tool specifically designed to strengthen and standardize bedside pump position assessment in critical care.
Real-Time Alert Capability
The system provides continuous real-time guidance and movement tracking, offering detailed, specific, and responsive instructions to the user on how to maneuver the ultrasound probe. It includes a 'Quality Bar' that indicates image diagnosability, and users are instructed to 'Hold position' and record a clip once optimal image quality is achieved.
Physician Tip

UltraSight Guidance empowers healthcare professionals, including those without prior sonography experience, to acquire high-quality cardiac ultrasound images at the point of care. This can significantly expand access to diagnostic imaging, accelerate clinical decision-making, and streamline workflows in various settings like emergency departments, critical care, and outpatient clinics. While the AI provides real-time guidance for image acquisition, it's crucial for physicians to independently review saved video clips and apply experienced clinical judgment for diagnosis, as individual patient variations may introduce errors.

UltraSight Guidance is designed as an accessory to compatible general-purpose diagnostic ultrasound systems, including handheld, laptop, and cart-based systems. It has been integrated with devices like the Philips Lumify Ultrasound System. The platform supports efficient onboarding and activation within existing clinical workflows, allowing health systems to deploy the technology across their current ultrasound fleets without requiring new hardware. Studies have also explored its combined use with AI-enabled electrocardiography (AI-ECG) to further enhance diagnostic accuracy for structural heart disease.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing — Basic; Pro; Enterprise
DeploymentSoftware application, pairs with compatible Point-of-Care Ultrasound (PoCUS) devices.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

UltraSight AI Guidance received FDA 510(k) clearance (K223347 and K251416) for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. It is indicated to assist medical professionals (not including expert sonographers) in acquiring 10 standard cardiac ultrasound views.
Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Emergency Medicine

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Press & Coverage

PR Newswire
UltraSight Granted Patent for Real-Time Guidance Ultrasound Technology
UltraSight announced it has been granted a patent by the U.S. Patent and Trademark Office (USPTO) for its real-time guidance ultrasound technology, which uses AI to enable medical professionals with no prior sonography experience to perform high-quality cardiac ultrasound examinations.
2023-02
UltraSight
UltraSightu2122 Receives KFDA Regulatory Approval for AI Guidance System, Expanding Global Access to Cardiac Imaging
UltraSight received regulatory approval from South Korea's Ministry of Food and Drug Safety (KFDA) for its real-time machine learning guidance software, a significant step in expanding access to cardiac imaging in Asia.
2025-06
UltraSight
JACEP Open Publication Demonstrates Economic Benefits to Healthcare Systems with AI-Guided TTE-First Strategies
New findings published in the Journal of the American College of Emergency Physicians Open (JACEP Open) highlight the potential for UltraSight's AI-guided transthoracic echocardiograms (TTEs) to reduce hospital stays and healthcare costs.
2025-04
FDA
K251416 - UltraSight Guidance
This FDA 510(k) Premarket Notification document details the UltraSight Guidance system, intended to assist medical professionals in acquiring cardiac ultrasound images, and its indication for use in various 2D-TTE standard views for adult patients.
2025-12
Signify Research
Ultrasound u2013 It's Coming Homeu201a But When?
This article discusses the trend of bringing ultrasound to home settings, mentioning UltraSight's CE mark approval in August 2022 for its guidance solution, which provides real-time instructions for acquiring diagnostic-quality cardiac ultrasound images.
2022-10
BMJ Open
Reliability of minimally-trained operator's Left Ventricular Outflow Tract Velocity-Time Integral measurement guided by artificial intelligence. Protocol for a randomised controlled trial.
This peer-reviewed protocol outlines a multicenter randomized controlled trial to assess the reliability of minimally-trained operators measuring Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI) using UltraSight AI software guidance.
2026-05
UltraSight
AI REAL TIME GUIDANCE PIVOTAL STUDY RESULTS
UltraSight successfully concluded its multicenter pivotal study, demonstrating that novice users, after minimal training with the real-time guidance software, can acquire diagnostic-quality cardiac images comparable to expert sonographers.
2023-09
UltraSight
UltraSight AI Guidance User Manual
This user manual provides detailed information on the UltraSight AI Guidance software, an accessory compatible with the Philips Lumify S4-1 ultrasound transducer, designed to assist medical professionals in acquiring ten specific cardiac views.
2025-01

Videos

Product demos, reviews, and walkthroughs for UltraSight Guidance.

View all on YouTube

Frequently Asked Questions

UltraSight Guidance integrates as an accessory to compatible general-purpose diagnostic ultrasound systems, providing real-time AI-powered guidance for acquiring standard cardiac ultrasound views. Its AI analyzes the ultrasound video stream to offer visual cues for probe positioning and feedback on image quality, assisting medical professionals who are not expert sonographers in obtaining diagnostic-quality images.
UltraSight Guidance has received FDA clearance in the U.S., CE Mark in the EU, UKCA Mark in the UK, and KFDA approval in South Korea, classifying it as a Class II medical device. While specific HIPAA compliance details are not fully outlined, the user manual refers to the ultrasound system's cybersecurity provisions and general health IT privacy resources, emphasizing that the software must be operated under the direction and supervision of a licensed physician.
Alternatives to UltraSight Guidance include traditional ultrasound methods requiring extensive sonographer training, as well as other AI-guided ultrasound solutions like Caption Guidance, which is a predicate device. UltraSight differentiates itself by offering real-time, AI-assisted image acquisition specifically for 10 standard cardiac views, enabling medical professionals without prior sonography experience to achieve diagnostic-quality images with enhanced speed and consistency.
UltraSight offers flexible pricing models, including accessible options for individual professionals and scalable plans for small to mid-sized teams. For larger organizations and enterprises, custom pricing is available, which may include dedicated support, custom integrations, advanced security features, and flexible contract terms. Specific costs are best obtained by contacting UltraSight's sales team for a tailored quote.
UltraSight Guidance is intended to assist, not replace, expert sonographers, and its use is limited to acquiring 10 specific 2D-TTE cardiac views in adult patients. While validated for accuracy, individual patient variations or similar views may introduce errors, necessitating independent review of saved video clips by a physician. The software operates in parallel with the ultrasound system's own software and is currently active only in B-Mode 2D Landscape.
Multiple clinical studies, including a randomized controlled trial from Stanford University and multicenter pivotal studies, have validated UltraSight Guidance. These studies demonstrate that medical professionals with minimal or no prior echocardiography experience can achieve meaningful proficiency and acquire diagnostic-quality cardiac images faster and with higher quality compared to traditional methods.
UltraSight Guidance is designed to significantly reduce the training burden, enabling medical professionals without prior sonography experience to achieve diagnostic-quality cardiac imaging proficiency after minimal training. Studies have shown that users can reach clinically meaningful proficiency after approximately 5 scans, a substantial reduction compared to the 20-30 supervised scans typically required for traditional POCUS education.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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