Hi-D Imaging AG

Winterthur, Switzerland All Switzerland companies → — Founded 2019

Imaging AI Specialist Specialty-Focused AI

Cardiology Cardiothoracic Surgery Radiology

Cardiology AI Surgical AI

Early Stage VC / Accelerator

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Products

Hi-D Imaging 4TAVR

Hi-D Imaging AG

Cardiology AI

Hi-D Imaging 4TAVR is an FDA 510(k) cleared, AI-powered, cloud-based software that provides fully automated measurements for pre-procedural Transcatheter Aortic Valve Replacement (TAVR) planning, enhancing decision-making and streamlining clinical workflows.

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About Hi-D Imaging AG

Hi-D Imaging AG is a medical technology company that develops AI-based software for cardiovascular pre-operational planning and patient-specific blood flow analysis. The company’s platform is designed to produce detailed pictures of the structures within and around the heart, aiming to revolutionize medical image processing for cardiology.

For physicians, Hi-D Imaging’s technology offers an AI-based decision-making support software that predicts blood flow abnormalities directly from CT or MRI scans. This information is then used for diagnosis, treatment planning, and risk assessment for cardiac operations. The company’s products, such as the Hi-D Imaging 4TAVR, are cloud-based, one-click solutions that provide fully automated measurements of clinically-relevant parameters to assist in pre-procedural Transcatheter Aortic Valve Replacement (TAVR) planning. This approach aims to decrease pre-operational/surgical planning times, overcome limitations of traditional medical scans, and reduce inter-observer and intra-observer variability in measurements, ultimately enabling medical professionals to better assist patients with cardiovascular diseases and potentially reduce unnecessary medical imaging examinations.

Focus Areas

Cardiovascular Imaging Medical AI Healthcare Analytics Medical Devices Computer Vision Digital Twin Clinical Decision Support Hemodynamic Analysis Pre-surgical Planning Transcatheter Aortic Valve Replacement (TAVR) Computational Fluid Dynamics (CFD) Medical Image Segmentation SaaS Virtual Surgery AI-powered Surgery Software as a Medical Device (SaMD)

Business Intelligence

Technology

Cloud-based AI software, Deep Learning, Computer Vision, SaaS platform, 3D printing, in vitro imaging

What Physicians Need to Know

Cardiovascular Pre-operational Planning

Hi-D Imaging specializes in revolutionizing pre-operational planning for cardiovascular diseases, aiming to reduce complexity and time. Their 4TAVR software, for instance, offers fully automated measurements for Transcatheter Aortic Valve Replacement (TAVR) planning, improving accuracy, precision, and efficiency.

AI-based Decision-Making Support

The company provides AI-based software solutions that predict blood flow abnormalities directly from CT or MRI scans. This information is used for diagnosis, treatment planning, and risk assessment for cardiac operations, offering unprecedented support to healthcare professionals.

Blood Flow Analysis & Digital Twins

Hi-D Imaging offers patient-specific blood flow analysis and creates digital twins to mimic patient-specific blood flow under various conditions. This helps in understanding cardiovascular diseases and optimizing medical device designs.

Medical Imaging Processing & 3D Printing

They are experts in medical imaging processing for cardiology, combining fluid dynamics, machine learning, computer vision, 3D printing, and in vitro imaging. This multidisciplinary approach provides a unique competitive advantage.

Structural Heart Interventions

Hi-D Imaging's Cardiovascular Imaging Suite supports pre-operational planning for structural heart diseases, offering automated measurements and advanced 3D visualization for comprehensive cardiac analysis.

Physician Tip

For physicians, Hi-D Imaging's solutions, particularly the 4TAVR software, offer fully automated, accurate, and reproducible measurements for TAVR planning, significantly streamlining clinical workflows and providing tailored recommendations for prosthesis and valve sizing. The cloud-based, one-click solution eliminates complex installations, training needs, and manual work, allowing more time for patient care. Their AI-powered tools help in making faster, more informed decisions by providing detailed cardiovascular treatment planning and patient-specific blood flow analysis. The use of digital twins can also aid in understanding complex patient anatomies and predicting the effects of interventions.

Hi-D Imaging's Cardiovascular Imaging Suite is a cloud-based, AI-empowered platform that works with standard anonymized DICOM files. It is designed as a web-based SaaS platform, meaning users can access it through an internet browser without complex installation or setup. The 4TAVR product has received FDA 510(k) clearance and is available in the US market, with ongoing testing in the EU. The company's multidisciplinary approach combines fluid dynamics, machine learning, computer vision, 3D printing, and in vitro imaging, suggesting potential for integration with various data sources and technologies in these fields.

Products by Hi-D Imaging AG

1 product in the directory

Hi-D Imaging 4TAVR

Hi-D Imaging AG

Cardiology AI

Contact for pricing

What the Web Says

Hi-D Imaging AG is a Swiss medical technology company founded in 2019 that specializes in AI-based software for cardiovascular pre-operational planning and patient-specific blood flow analysis. Their flagship product, 4TAVR, is a cloud-based SaaS platform designed to automate measurements for Transcatheter Aortic Valve Replacement (TAVR) planning, aiming to streamline clinical workflows and reduce manual work. The company emphasizes its multidisciplinary approach, combining fluid dynamics, machine learning, computer vision, 3D printing, and in vitro imaging.

Overall: Positive

Strengths

AI-powered automation for cardiovascular pre-operational planning saves time and reduces variability.
4TAVR offers accurate, reproducible, and fast case evaluations with tailored recommendations for prosthesis and valve size.
The software is a web-based, one-click SaaS platform, eliminating complex installations, configurations, and updates.
Extensively validated in clinical studies across Switzerland, Europe, and the USA.
Key opinion leaders view the tool as a potential game-changer in structural heart disease.
Focus on creating digital twins for patient-specific conditions to optimize medical device development.

Limitations

No readily available negative reviews or opinions from the specified platforms (G2, Glassdoor, Capterra, Reddit) were found.
Specific pricing and licensing options are not explicitly detailed in the provided information.
As a private company, detailed valuation and secondary market data are not publicly available.

Based on reviews from: Hi-D Imaging, Caplight, Facebook

Last updated: 2026-10-18

Videos

News, demos, and interviews about Hi-D Imaging AG.

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Press & Coverage

Startupticker.ch

Four Swiss medtechs mark commercial, regulatory and clinical milestones

Hi-D Imaging AG is mentioned among four Swiss medtech companies achieving commercial, regulatory, and clinical milestones, highlighting its AI-based decision-making support software for cardiac operations.

2026-07-27

Transparency Registry

Hi-D Imaging 4TAVR — K261535 | Transparency Registry

This entry details the FDA 510(k) clearance for Hi-D Imaging 4TAVR, cleared on July 20, 2026, under an AI-associated product code.

2026-08-29

Innolitics

2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances

Hi-D Imaging 4TAVR is listed among the FDA-cleared AI/ML-related cardiology devices in 2025, with a clearance date of April 2, 2025.

2026-01-13

Transparency Registry

Hi-D Imaging AG — FDA AI clearances (2) | Transparency Registry

This page provides an overview of Hi-D Imaging AG's two FDA 510(k) clearances for AI-associated products, including device details and dates.

unknown

FDA

K241984 - 510(k) Premarket Notification - FDA

This FDA document details the 510(k) Premarket Notification for Hi-D Imaging 4TAVR by Hi-D Imaging AG, with Utku Gulan listed as a contact.

2026-10-19

Frequently Asked Questions

What specific problems does Hi-D Imaging AG's AI-based software solve in cardiovascular pre-operational planning and structural heart interventions?

Hi-D Imaging AG's AI-based software aims to enhance pre-operational planning for cardiovascular procedures, particularly structural heart interventions like TAVR. It provides advanced blood flow analysis and leverages digital twin technology to offer more precise insights into patient-specific anatomies and hemodynamics, ultimately supporting better surgical outcomes.

How does Hi-D Imaging AG ensure the accuracy and reliability of its AI-driven decision-making support, especially concerning medical imaging processing and deep learning algorithms?

Hi-D Imaging AG focuses on robust medical imaging processing and deep learning algorithms to ensure the accuracy of its AI-driven decision support. The company likely employs rigorous validation processes and adheres to relevant medical device regulations to ensure the reliability and safety of its software for clinical use.

What are the key features and benefits of Hi-D Imaging AG's products for TAVR planning, and how do they integrate with existing cardiology workflows?

Hi-D Imaging AG's products for TAVR planning likely offer advanced 3D visualization, blood flow analysis, and potentially patient-specific digital twins to optimize implant selection and placement. The company aims for seamless integration with existing cardiology workflows, providing physicians and healthcare administrators with intuitive tools that enhance current planning protocols.

Can you provide information on the regulatory compliance (e.g., FDA, CE Mark) of Hi-D Imaging AG's software and any in vitro imaging concerns?

While specific regulatory clearances (FDA, CE Mark) would need to be confirmed directly with Hi-D Imaging AG, the company operates within the medical imaging and AI space, implying a commitment to achieving necessary regulatory approvals for its products. Any in vitro imaging concerns would be addressed through their product design and validation processes to ensure data integrity and clinical applicability.

What is the pricing model for Hi-D Imaging AG's solutions, and what kind of technical support and training can healthcare institutions expect?

The specific pricing model for Hi-D Imaging AG's solutions would typically involve licensing fees, subscriptions, or per-procedure costs, which would be detailed in direct discussions with the company. Healthcare institutions can generally expect comprehensive technical support, including implementation assistance, ongoing maintenance, and training programs for medical staff to ensure effective utilization of their software.

What partnerships does Hi-D Imaging AG have with other medical device companies or research institutions, and what is the company's long-term stability and vision?

Hi-D Imaging AG's partnerships with medical device companies or research institutions would likely focus on advancing their AI and imaging technologies and expanding their market reach. Information on the company's long-term stability and vision would typically highlight their commitment to innovation in cardiovascular care, their growth strategy, and their impact on improving patient outcomes through advanced digital health solutions.

How does Hi-D Imaging AG's technology, particularly its use of computer vision and 3D printing, contribute to personalized medicine in cardiology?

Hi-D Imaging AG's integration of computer vision and potentially 3D printing technologies allows for highly personalized approaches in cardiology. Computer vision aids in precise analysis of medical images, while 3D printing could be utilized to create patient-specific anatomical models for pre-surgical planning and training, thereby enhancing the customization and effectiveness of cardiovascular interventions.

Comparisons

Hi-D Imaging 4TAVR vs EchoNext

Hi-D Imaging 4TAVR vs Lung Density Analysis

SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION vs Hi-D Imaging 4TAVR

SENSICARDIAC vs Hi-D Imaging 4TAVR

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