UltraSight AI Guidance

by UltraSight  · Based in United States →Empowering Cardiac Ultrasound With AI
Cardiology Critical Care Emergency Medicine

Contact for pricing
Regulatory Status Disclosed

Overview

UltraSight AI Guidance is an innovative, AI-driven software designed to revolutionize cardiac sonography by making high-quality cardiac ultrasound imaging accessible to a broader range of healthcare professionals. The mobile AI-based application pairs with compatible general-purpose diagnostic ultrasound systems, including handheld, laptop, and cart-based devices. It provides real-time guidance and quality assessment, assisting medical professionals, even those without prior sonography experience, in acquiring diagnostic-quality 2D transthoracic echocardiography (2D-TTE) images.

The software analyzes the ultrasound stream and offers dynamic, real-time instructions on how to maneuver the ultrasound probe in three dimensions (X, Y, and Z axes) to achieve optimal views. A continuous quality bar score and graphical probe manipulation cues help users maintain proper transducer positioning and ensure diagnostic image quality. UltraSight AI Guidance supports the acquisition of 10 standard cardiac views, enabling faster diagnosis, earlier treatment, and increased patient access to critical cardiac care in various settings, including clinics, community hospitals, emergency departments, and remote areas.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time AI guidance for ultrasound probe positioning and orientation
  • Image quality assessment and feedback (quality bar score)
  • Guidance for 10 standard cardiac views (e.g., PLAX, AP4, SubC4)
  • 3D guidance user interface with magnitude of movement instructions
  • Continuous real-time guidance and movement tracking
  • Compatibility with various ultrasound systems (handheld, laptop, cart-based)
  • Mobile AI-based application for tablets
  • Enables non-sonographers to acquire diagnostic-quality images
  • Supports faster diagnosis and earlier treatment
  • Reduces repeat imaging and increases operational efficiency

Use Cases

  • Point-of-Care Ultrasound (PoCUS) in emergency departments
  • Out-of-hospital care and remote/rural areas
  • Early detection of Stage B heart failure
  • Screening for structural heart disease
  • Maternal health cardiac assessments
  • Management of patients with microaxial flow pumps (PVAD IQ)

What Physicians Need to Know

ECG/EKG Analysis Capability
UltraSight's Echosystem can be combined with AI-enhanced ECG for structural heart disease screening. This two-step pathway (AI-ECG followed by AI-guided focused cardiac ultrasound) has shown to increase the positive predictive value for identifying reduced left ventricular ejection fraction (LVEF) or significant aortic valve disease.
Echocardiography AI Features
UltraSight's core offering is real-time AI guidance for acquiring 10 standard 2D transthoracic echocardiography (2D-TTE) views. The software analyzes the ultrasound stream, predicts probe position, and provides real-time visual instructions on how to maneuver the probe to obtain diagnostic-quality images, including a real-time image quality meter. It enables medical professionals without prior sonography experience to acquire high-quality cardiac ultrasound images.
Heart Failure Risk Prediction
The AI platform demonstrated a 95% negative predictive value for identifying patients with LVEF below 50%, indicating its potential for early detection and intervention in heart failure. Novice users, guided by UltraSight's software, have successfully performed cardiac ultrasounds for the early detection of Stage B heart failure. Studies also support its use for bedside assessment in acute decompensated heart failure and estimation of Left Ventricular Enlargement.
Cardiac Monitoring Integration
UltraSight's Real-Time Guidance software is designed to optimize and streamline cardiac monitoring and clinical workflows by enabling non-sonographers to achieve consistent, diagnostic-quality ultrasound. It aims to improve access to echocardiographic assessments for patients requiring consistent cardiac follow-up, such as those with obstructive hypertrophic cardiomyopathy (oHCM), and supports AI-enabled workflows in cardiac critical care for pump position assessment.
AHA/ACC Guideline Alignment
UltraSight's technology has been validated through clinical studies presented at major cardiology conferences, including the American College of Cardiology (ACC) Annual Meeting, often in collaboration with institutions like Mayo Clinic. The Echosystem supports focused and limited transthoracic echocardiography workflows that generally align with established guidelines.
Real-Time Alert Capability
The software provides continuous, real-time AI feedback and guidance, offering specific instructions on how to move the ultrasound probe in three dimensions. It includes a real-time visual image quality meter that indicates when the quality threshold is met for capturing a diagnostic image.
Physician Tip

UltraSight AI Guidance empowers healthcare professionals, including those without prior sonography experience, to acquire diagnostic-quality cardiac ultrasound images, thereby expanding access to critical cardiac imaging. It can accelerate skill acquisition for residents and reduce variability in focused cardiac ultrasound (FoCUS) exams. Physicians should view this as an assistive tool to enhance diagnostic efficiency and patient access, particularly for screening, surveillance, and in critical care settings, while maintaining qualified physician oversight for final interpretation and reporting. The technology has demonstrated high accuracy in detecting conditions like reduced LVEF and aortic stenosis when used by novice scanners.

UltraSight AI Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. It has received FDA clearance for expanded compatibility with a wider variety of ultrasound systems, including handheld, laptop, and cart-based devices, allowing deployment across existing ultrasound fleets without requiring new hardware. The software is compatible with the Philips Lumify Ultrasound System and is integrating with Butterfly Network's imaging platform for use with their single-probe, whole-body handheld ultrasound system.

Details

Category Cardiology AI
Pricing Contact for pricing Contact for pricing; custom enterprise pricing available.
DeploymentMobile AI software application, pairs with compatible general-purpose diagnostic ultrasound devices.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

UltraSight AI Guidance received FDA 510(k) clearance on July 24, 2023 (K223347) for assisting medical professionals (not expert sonographers) in acquiring 10 standard 2D transthoracic echocardiography (2D-TTE) views for adult patients. An expanded clearance was granted on January 6, 2026, to support compatibility with a wider variety of ultrasound systems (handheld, laptop, cart-based).

Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Emergency Medicine

What the Web Says

UltraSight AI Guidance is an AI-powered software designed to assist medical professionals, including those without prior sonography experience, in acquiring high-quality cardiac ultrasound images. The system provides real-time guidance and quality assessment, aiming to expand access to cardiac imaging and facilitate earlier diagnosis and treatment of heart conditions. Studies have shown that novice users, after minimal training, can obtain diagnostic-quality images comparable to those acquired by expert sonographers.

Overall: Positive

Strengths

  • Enables novice users to acquire diagnostic-quality cardiac ultrasound images with minimal training.
  • Expands access to cardiac imaging in various care settings, including remote and rural areas.
  • Reduces the learning curve and training time for performing echocardiograms.
  • Provides real-time AI guidance and feedback for probe manipulation and image quality assessment.
  • Supports faster diagnosis and more timely clinical decisions.
  • Can be deployed across existing ultrasound fleets, including handheld, laptop, and cart-based systems.

Limitations

  • No specific cons were found in the provided search results.
  • Potential resistance from some radiologists to widespread adoption of AI in ultrasound.

Based on reviews from: UltraSight, StartupHub.ai, BioWorld, EIN Presswire, AdvaMedu00ae, PMC, The National Law Review, AuntMinnie, Reddit, accessdata.fda.gov, ProQuest, Definitive Healthcare

Last updated: 2026-07-19

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Press & Coverage

UltraSight
New Data at ACC.26 Demonstrating UltraSightu00ae AI Enables Non-Experts to Perform Diagnostic Cardiac Ultrasound
UltraSight announced new data presented at ACC.26, highlighting how its AI technology enables non-experts to perform diagnostic cardiac ultrasounds. This expands access to critical cardiac imaging across various care settings.
2026-03
UltraSight
UltraSightu00ae Receives FDA Clearance to Expand Its AI-Guided Cardiac Echo Stewardship Platform Across Ultrasound Systems
UltraSight received FDA clearance to expand its AI-guided cardiac echo stewardship platform, allowing compatibility with various ultrasound systems including handheld, laptop, and cart-based devices. This enables health systems to scale AI-guided focused cardiac ultrasound using existing equipment.
2026-01
UltraSight
UltraSight Receives KFDA Regulatory Approval for AI Guidance System, Expanding Global Access to Cardiac Imaging
UltraSight announced that its real-time machine learning guidance software received regulatory approval from South Korea's Ministry of Food and Drug Safety (KFDA), expanding global access to cardiac imaging.
2025-06
UltraSight
JACEP Open Publication Demonstrates Economic Benefits to Healthcare Systems with AI-Guided TTE-First Strategies
UltraSight announced the publication of new findings in the Journal of the American College of Emergency Physicians Open (JACEP Open), demonstrating the economic benefits of AI-guided TTE-first strategies for healthcare systems.
2025-04
UltraSight
UltraSight Showcases New Data at ACC 2025 Highlighting the Accuracy and Accessibility of AI-Guided Cardiac Imaging
UltraSight presented three abstracts at the American College of Cardiology (ACC) Annual Meeting 2025, showcasing studies conducted with Mayo Clinic that validate the accuracy and accessibility of its AI-guided cardiac imaging for novice users.
2025-04
UltraSight
UltraSight Joins Butterfly Garden to Expand AI Real-Time Guidance Across Point of Care Ultrasound Devices
UltraSight joined Butterfly Garden, an AI Marketplace launched by Butterfly Network, Inc., to expand its AI real-time guidance across point-of-care ultrasound devices and enable more patients to access cardiac imaging.
2024-06
UltraSight
FDA Grants Clearance for UltraSight's AI-Powered Cardiac Ultrasound Technology
UltraSight received FDA clearance for its AI-powered ultrasound guidance technology, which assists medical professionals without sonography experience in acquiring cardiac ultrasound images at the point of care.
2023-07
BioWorld
Ultrasight's AI cardiac imaging tool a 'game changer' for heart patients | BioWorld
BioWorld reported on UltraSight's FDA clearance, highlighting how the AI-powered ultrasound guidance technology is a 'game changer' for heart patients by enabling widespread detection of heart diseases and easing healthcare system bottlenecks.
2023-08

Videos

Product demos, reviews, and walkthroughs for UltraSight AI Guidance.

View all on YouTube

Frequently Asked Questions

UltraSight AI Guidance provides real-time visual feedback and instructions, including probe positioning and an image quality meter, to help medical professionals, even those without extensive sonography experience, acquire diagnostic-quality focused cardiac ultrasound (FoCUS) images. This streamlines the image acquisition process and aims to reduce variability across users, making cardiac imaging more accessible.
UltraSight AI Guidance has received FDA clearance to expand its Echo Stewardship Platform, allowing its use with various compatible ultrasound systems, including handheld, laptop, and cart-based devices. It also holds CE Mark for the EU and UKCA Marking for the UK, and KFDA approval in South Korea, demonstrating its compliance with international medical device regulations.
UltraSight AI Guidance is primarily designed to assist with 2D B-Mode landscape imaging for specific standard cardiac views and does not provide guidance for other ultrasound modes like Doppler, M-Mode, or Zoom. It is intended as an assistive tool for image acquisition, not for interpretation or to replace the comprehensive expertise of a sonographer.
Yes, there are other AI ultrasound solutions for cardiac imaging, such as Caption AI, HeartFocus, and Us2.ai. UltraSight differentiates itself by focusing on real-time guidance for image acquisition across various compatible point-of-care ultrasound (POCUS) devices, aiming to democratize access to quality cardiac imaging by simplifying the acquisition process for a broader range of healthcare professionals.
Specific pricing models for UltraSight AI Guidance are not publicly disclosed in the available information. Typically, healthcare AI solutions are licensed through subscription models or per-use fees, and interested healthcare facilities would need to contact UltraSight directly for detailed pricing and integration options tailored to their specific needs.
Studies have shown that medical professionals, including nurses and residents with minimal or no prior sonography experience, can acquire diagnostic-quality cardiac images after undergoing a brief training session, often as short as one day, combined with practice scans using the UltraSight AI Guidance software. The system is designed to significantly flatten the learning curve for cardiac ultrasound image acquisition.
While specific details on data security protocols were not explicitly detailed in the provided search snippets, healthcare AI solutions like UltraSight are generally expected to comply with stringent regulations such as HIPAA. The software operates as an accessory to compatible ultrasound systems, meaning data handling would typically adhere to the security frameworks of the integrated devices and the healthcare facility's existing IT infrastructure.

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