AI software and digital twin services for preoperative planning in cardiology

Hi-D Imaging AG

Winterthur (CH)New on Amplifa

2019Founded

Winterthur, SwitzerlandHeadquarters

FDA 510(k)4TAVR clearance

About Hi-D Imaging

Hi-D Imaging AG was founded in 2019 in Winterthur by Dr. Utku Gülan and Dr. Özge Karakas, both former postdocs at ETH Zurich. The company develops AI-based software for the preoperative planning of cardiovascular interventions as well as digital twin services that map patient-specific blood flow simulations for medical device manufacturers and researchers. The core products are the Cardiovascular Imaging Suite with the 4TAVR software, which has received FDA 510(k) clearance. The methodology combines fluid dynamics, machine learning, computer vision, 3D printing and in-vitro imaging. Customers include Texas Health Resources and Justus Liebig University Giessen. The software is available on the market in the USA; in the EU it is currently offered for testing purposes only.

Site: Winterthur
Processes: AI-based software for preoperative planning in cardiology (Cardiovascular Imaging Suite /, Digital twin service: patient-specific blood flow simulations for, 3D printing (mentioned as part of the multidisciplinary methodology), In-vitro imaging (mentioned as part of the multidisciplinary methodology), AI-based software for preoperative planning in cardiology, Digital twins for patient-specific blood flow analysis, Medical image processing, Support for medical device manufacturers and researchers
Materials: AI-based software for preoperative planning, Digital Twin, 3D Printing, In-vitro imaging
Certificates: FDA 510(k) Clearance (product 4TAVR), FDA 510(k) (4TAVR)
Founded: 2019
Industries: Cardiology, Medical technology, Healthcare, Research

01
Medical image processing
02
Automated segmentation and measurement
03
Digital twin creation
04
Patient-specific blood flow simulation
05
Preoperative decision support

Processes and Technologies

AI-based software for preoperative planning

Automates segmentation, reconstruction and anatomical measurements for cardiologists and medical device manufacturers

Digital Twin

Patient-specific blood flow simulations to support medical device development and research

3DP

3D Printing

Part of Hi-D Imaging's multidisciplinary methodology

IVI

In-vitro imaging

Part of the multidisciplinary methodology for validation

Locations

Winterthur

Headquarters

Products and Services

**4TAVR Software**AI-based planning software · Cardiology

**AI Deep Learning Processing**Medical image processing · Medical technology

Inside the production

Industries

CardiologyMedical technologyHealthcareResearch

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
AI-based software for preoperative planning in cardiology (Cardiovascular Imaging Suite /Engineering	–	–	–	–	–
Digital twin service: patient-specific blood flow simulations forEngineering	–	–	–	–	–
3D printing (mentioned as part of the multidisciplinary methodology)Additive	–	–	–	–	–
In-vitro imaging (mentioned as part of the multidisciplinary methodology)Testing	–	–	–	–	–

Additional services

AI-based software for preoperative planning in cardiologyDigital twins for patient-specific blood flow analysisMedical image processingSupport for medical device manufacturers and researchers

Reference customers

Texas Health ResourcesUniversity Hospital Giessen (PD Dr. Won Keun-Kim, Justus Liebig University Giessen)

Quality and Regulatory Affairs

The 4TAVR software has received FDA 510(k) clearance for the US market.

Evidence	Winterthur
FDA 510(k) (4TAVR)

History

2019
Founding of Hi-D Imaging by Dr. Utku Gülan and Dr. Özge Karakas (former postdocs at ETH Zurich)
4TAVR software receives FDA 510(k) clearance