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 an ETH Spinoff MedTech company focused on revolutionizing medical imaging for cardiovascular diseases. They develop an AI-based decision-making support software that analyzes CT and MRI scans to predict blood flow abnormalities. This technology is designed to assist physicians in the diagnosis, treatment planning, and risk assessment for cardiac operations, aiming to reduce the complexity and time involved in pre-operational/surgical planning.

The company’s offerings include a cutting-edge Digital Twin technology, which integrates in vitro imaging, advanced computer vision, and fluid dynamics expertise to provide unparalleled insights into cardiovascular treatment planning, enabling more precise and patient-specific solutions. Their product, 4TAVR, is a cloud-based AI software that provides fully automated measurements for pre-procedural Transcatheter Aortic Valve Replacement (TAVR) planning, streamlining clinical workflows by offering accurate, reproducible, and rapid case evaluations, including tailored recommendations for prosthesis and valve sizing.

Focus Areas

Cardiovascular disease pre-operational planning structural heart interventions AI-based decision-making support software blood flow analysis digital twins TAVR planning medical imaging processing cardiology deep learning computer vision 3D printing in vitro imaging

Business Intelligence

Key InvestorsVenture Kick, HeartX Accelerator, HealthTech Arkansas Programs
PartnershipsTexas Health Resources (clinical partner), University of Giessen Department of Cardiology & Angiology, ELEM Biotech SL (EUROSTARS project partner), Swiss m4m Center (Innovation cheque project partner)
TechnologyCloud-based, AI-empowered platform, deep learning, computer vision algorithms, web-based SaaS platform
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Cardiovascular Pre-operational Planning
Hi-D Imaging AG specializes in revolutionizing pre-operational planning for cardiovascular diseases, offering tools and services that automate time-consuming manual tasks.
Structural Heart Interventions & TAVR Planning
Their flagship 4TAVR software, which is FDA 510(k) cleared, provides fully automated measurements for Transcatheter Aortic Valve Replacement (TAVR) planning, streamlining workflows and improving accuracy for structural heart interventions.
AI-based Decision-Making Support
The company develops AI-based software solutions that offer unprecedented support to healthcare professionals by enhancing decision-making with data-driven insights and predicting blood flow abnormalities directly from CT examinations.
Blood Flow Analysis & Digital Twins
Hi-D Imaging provides validated methods for patient-specific blood flow analysis and creates digital twins to mimic patient-specific conditions, aiding in treatment planning and medical device development.
Medical Imaging Processing
They leverage state-of-the-art technologies like deep learning and computer vision to process medical images for comprehensive cardiac analysis and 3D visualization.
Key Differentiators
Key differentiators include their FDA 510(k) cleared 4TAVR software, fully automated and reproducible measurements, a cloud-based 'one-click' SaaS platform requiring no installation or training, and a multidisciplinary approach combining fluid dynamics, machine learning, computer vision, 3D printing, and in vitro imaging.
Technology Stack
Their technology stack is centered on AI, deep learning, and computer vision algorithms, delivered through a web-based SaaS platform that processes standard anonymized DICOM files.
Physician Tip

For physicians, Hi-D Imaging AG stands out by significantly reducing the manual, time-consuming work associated with pre-operational planning through their fully automated, AI-powered solutions. The FDA 510(k) clearance for their 4TAVR software provides a strong indicator of reliability and accuracy for TAVR planning. The platform's ability to provide highly reproducible measurements helps mitigate inter-observer and intra-observer variability, leading to more consistent and precise patient care. Furthermore, the use of patient-specific digital twins offers a powerful tool for simulating various treatment scenarios and optimizing device selection, potentially leading to improved patient outcomes and reduced complications in complex cardiovascular cases. The cloud-based, 'one-click' nature of their software ensures a streamlined workflow with minimal IT overhead or training requirements.

Hi-D Imaging AG's Cardiovascular Imaging Suite is a cloud-based, web-based SaaS platform. It is designed for seamless integration into existing clinical workflows, requiring no complex installation, configuration, or updates. Physicians can access the software directly through an internet browser and upload standard anonymized DICOM files for analysis.

Products by Hi-D Imaging AG

1 product in the directory

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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Press & Coverage

FDA
510(k) Premarket Notification - K241984 Hi-D Imaging 4TAVR
Hi-D Imaging AG received 510(k) Premarket Notification for their Hi-D Imaging 4TAVR device, classified under product code QIH (Medical image management and processing system) and LLZ (Computer, Diagnostic, Programmable). The notification was submitted on July 8, 2024, and cleared on April 2, 2025.
2025-04
Startupticker.ch
23 start-ups qualified for the second stage of the Innosuisse Scale-up Coaching program
Hi-D Imaging AG qualified for the second stage of the Innosuisse Scale-up Coaching program, which helps startups refine and implement their growth strategy. Hi-D Imaging provides AI-based decision-making support software for patient-specific diagnosis and treatment of cardiac diseases.
2025-07
Startupticker.ch
Mingling with international players
Hi-D Imaging, a Winterthur-based medtech startup, gained membership in the NVIDIA Inception Program, providing access to developer resources and training to scale its solutions globally. The company aims to revolutionize medical imaging for cardiovascular diseases by reducing pre-operational planning complexity.
2024-09
Startupticker.ch
Four startups from the medical field obtain the Innosuisse Certificate
Hi-D Imaging AG obtained the Innosuisse Certificate, an award for medical startups. The company focuses on AI-based decision-making support software for cardiac diseases.
2024-08
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
Hi-D Imaging AG's Hi-D Imaging 4TAVR received FDA 510(k) clearance in April 2025, as part of a trend of 92 AI/ML-related FDA clearances in 2025, with a significant focus on cardiology.
2026-01
Startupticker.ch
Startups gather Board members' expertise
Hi-D Imaging appointed Urs Christen to its board of directors. Christen brings extensive experience in international medical companies and will support Hi-D Imaging's AI-based software for cardiac pre-operational planning.
2023-07
Venturelab Swiss
From Academia to Impact: The Story of Dr. u00d6zge Karakas and Hi-D Imaging
Hi-D Imaging AG, co-founded by Dr. u00d6zge Karakas and Dr. Utku Gulan, has secured over $2.5 million in funding from investors including Venture Kick, HEMEX, MassChallenge, and the HeartX Accelerator. The company aims to revolutionize medical image processing for cardiology with its high-dimensional (4D) AI-based technology.
unknown
HEMEX
Welcome Hi-D Imaging!
HEMEX announced its partnership with Hi-D Imaging AG, an ETH Spin-off medtech company, to support their strategic clinical and regulatory development. Hi-D Imaging aims to make personalized aortic heart valve replacement therapy a reality using AI-based pre-operational planning.
2020-04

Frequently Asked Questions

Hi-D Imaging AG provides the Cardiovascular Imaging Suite, a platform that revolutionizes medical imaging processing for structural heart diseases. Their flagship product, Hi-D Imaging 4TAVR, is a cloud-based, AI-driven software that offers fully automated measurements for pre-procedural Transcatheter Aortic Valve Replacement (TAVR) planning.
The company's AI-based decision-making support software predicts blood flow abnormalities directly from CT or MRI scans, aiding in diagnosis, treatment planning, and risk assessment for cardiac operations. This technology automates complex pre-operational planning tasks, reducing inter-observer and intra-observer variability and improving efficiency for cardiologists.
Hi-D Imaging 4TAVR has received FDA 510(k) clearance for the US market. For the EU market, regulatory submission is currently being prepared, and while commercial sale is not yet possible, credentials for testing the software can be provided.
Hi-D Imaging AG offers Digital Twin services, creating patient-specific digital twins for medical device manufacturers and researchers to simulate blood flow under various conditions. Their validated methods provide unprecedented clarity and detail for cardiovascular treatment planning and patient-specific blood flow analysis.
Hi-D Imaging's Cardiovascular Imaging Suite is a web-based, SaaS platform that requires no complex installation or configuration, with all updates handled automatically. They emphasize outstanding support from a dedicated team, making implementation straightforward and user-friendly.
Hi-D Imaging AG, an ETH Spinoff incorporated in 2019, has secured funding through seed rounds and early-stage VC deals, indicating financial stability. They have established partnerships, including one with an American valve manufacturer and a clinical partnership with Texas Health Resources for further technology development.
Hi-D Imaging integrates deep learning and computer vision algorithms for fully automated segmentation and analysis of medical images, enhancing precision and efficiency. They also combine fluid dynamics, machine learning, and 3D printing to create digital twins and conduct in vitro imaging for comprehensive cardiovascular insights.

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