Partner News | Published: Wednesday, April 16, 2025
About the Company
Hi-D Imaging is a medtech company revolutionizing structural heart disease treatment planning through artificial intelligence (AI)-powered software and digital twin-based hemodynamics risk assessment solutions. Founded in 2019, with technology development dating back to 2008, the company has developed cutting-edge software that enhances the clinical decision-making process. Their flagship product, 4TAVR, utilizes deep learning algorithms to provide highly accurate, personalized assessments of anatomical structures, enabling more precise pre-procedural planning. Additionally, Hi-D Imaging has pioneered a second product, Digital Twin-Based Hemodynamics Analysis, which mimics patient-specific cardiovascular conditions to predict blood flow abnormalities, risk assessment and the impact of medical devices before the actual implantation. This platform serves medical device companies and research institutions, optimizing innovation in cardiac care.
The HeartX Experience
Hi-D Imaging joined the HealthTech Arkansas (HTA) Accelerator in 2021, before the program rebranded as HeartX. As an international company entering the U.S. market, the program provided essential connections to stakeholders, including hospitals, physicians and clinical researchers. HealthTech Arkansas was one of the company’s earliest accelerator experiences, offering valuable support and clinical engagement. Through the program, Hi-D Imaging gained insights into U.S. clinical workflows and established relationships with key healthcare institutions.
A critical outcome of Hi-D Imaging’s participation in the accelerator was the opportunity to conduct clinical validation studies at St. Bernards Healthcare and Arkansas Heart Hospital. These studies involved 149 cases, contributing to the company’s broader submission of 929 cases across five clinical studies to the U.S. Food and Drug Administration (FDA) for regulatory approval. The participation of these clinical sites accounted for one-sixth of the total validation dataset. Engaging directly with clinicians allowed Hi-D Imaging to refine its technology based on real-world pain points in cardiac imaging.
Since completing the accelerator, Hi-D Imaging has continued to expand its impact. The company has received ISO 13485 certification which ensures that the products meet the highest standard of safety, reliability and regulatory compliance.
Furthermore, the 4TAVR software has been officially FDA 510K cleared, which will be released to the U.S. market in May 2025. Moving forward, the company aims to enhance its AI-driven solutions for cardiovascular diagnostics, strengthen partnerships with U.S. healthcare institutions, and broaden its reach in the market.
Testimonials
"The HealthTech Arkansas Accelerator was instrumental in helping Hi-D Imaging gain early clinical validation in the U.S. market. The opportunity to work with Arkansas Heart Hospital and St. Bernards allowed us to test our technology in real-world clinical settings, refine our approach, and gather critical data for our FDA submission. The support from the program team was exceptional, providing unique clinical engagement that helped us navigate the complexities of entering the U.S. healthcare system." - Utku Gulan, PhD, CEO, Hi-D Imaging
"We are excited to have participated in the Hi-D Imaging trial. This trial brought cutting edge AI technology to the finger tips of structural physicians, serving to enhance and assist the physician in the care of valvular patients." - Amer Hawatameh, MD, Principal Investigator, St. Bernards Healthcare.
“The Hi-D Imaging platform brought an exciting new capability to our team. Their AI-driven technology enhanced our clinical decision-making and helped us better plan and assess treatment options for patients with aortic stenosis. Collaborating on this study gave us the opportunity to work with Hi-D Imaging in real-world settings, and we’re continuing to partner with them as they develop additional tools to support cardiovascular care.” - Andre Paixao, MD, Principal Investigator, Arkansas Heart Hospital.
About HeartX
HeartX, powered by HealthTech Arkansas and MedAxiom, is a cardiovascular-focused healthcare accelerator that facilitates guaranteed hospital pilot projects and clinical trials for accomplished, early-stage companies bringing new cardiovascular innovations to market. Together, HealthTech Arkansas and MedAxiom use their respective expertise to bring the latest cardiovascular healthcare innovations to the patients who need them most. Learn more.
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