Hemolens® Expands Pilot Program: New Clinical Site Joins Early-Stage Research Rollout

Across Europe and North America, healthcare is undergoing a profound transformation, accelerating toward availability, digitalization, and innovation. Cutting‑edge technologies such as AI‑driven analytics, cloud‑based platforms, and computational modeling are redefining diagnostics, particularly in cardiology and radiology. The global trend is clear: hospitals are partnering with high‑tech innovators to build smarter, safer, and more efficient care pathways, optimizing resource allocation and reducing inefficiencies in clinical operations.

Hemolens new partnership: a case study in forward thinking

In collaboration with the Voivodeship Specialist Hospital in Wrocław, Poland, we are conducting a pilot study to explore the potential of Cardiolens Viewer® in supporting CCTA image analysis, strictly within the scope of Research Use Only (RUO).

Cardiolens Viewer®, through advanced three-dimensional visualizations of coronary arteries and intuitive interfaces, enables the analysis and interpretation of complex imaging data in the context of research and education. The software can support research processes and the development of imaging data analysis methods in the field of coronary artery disease (CAD), but it is not approved for diagnostic, therapeutic, or other medical use.

Tomasz Roleder, MD, PhD of Voivodeship Specialist Hospital comments:

“As part of Hemolens’ pilot program, we are introducing the first module of the Cardiolens® Platform – the Cardiolens Viewer® – to evaluate its capabilities in cardiac CT image analysis. The pilot will allow us to assess workflow integration and gather valuable feedback for further development. We view this collaboration as an important step in advancing innovative tools that have the potential to transform future approaches to cardiovascular imaging.”

Why now: European & U.S. CCTA guidelines drive adoption

Major guideline bodies have championed CCTA as a first‑line tool:

• The European Society of Cardiology (ESC) according to the latest guidelines from 2024 granted CCTA a Class I A recommendation in the diagnosis of stable coronary artery disease (CAD).
• The 2025 ACC/AHA/ACEP/NAEMSP/SCAI guidelines position CCTA for patients’ evaluation with low-risk NSTE.
• In the U.S., the AHA/ACC/SCCT, as part of the 2021 Chest Pain guidelines, also elevated CCTA to Class 1A status for acute chest pain evaluation.
• The US Centers for Medicare & Medicaid Services (CMS) more than doubled the reimbursement for cardiac computed tomography angiography (CCTA), moving it from $175 up to $357.13.

Most recently, the Society of Cardiovascular Computed Tomography (SCCT) and related North American and European organizations have issued consensus white papers (2024–2025) on technical standards, AI & machine learning for CCTA, and standardized reporting frameworks – all reinforcing digital transformation in cardiovascular imaging. These guidelines call explicitly for precision, standardization, and reduced invasiveness.

Global innovation trends in cardiology and radiology

Radiology is grappling with an ever‑growing imaging volume, complexity, and demand for advanced modalities – placing enormous pressure on radiologists and cardiologists alike. At the same time, recent signals in 2025 point to:

• photon‑counting CT (PCCT) and whole‑body MRI systems,
• AI-infused CT workflows,
• new vendor partnerships and disruptive entrants across imaging markets.

These shifts align with pillars of actual medical technology challenges and opportunities, including innovation, AI, and precision diagnostics.

Addressing key pain‑points for interventional Cardiologists and Radiologists

• Interventional cardiologists seek reliable functional data without invasive coronary angiography unless truly necessary. They need validated non‑invasive metrics to plan interventions accurately and avoid unnecessary cath lab activation.
• Radiologists face alarmingly high workloads, complex image interpretations, and pressure to turn around CCTA reports quickly. AI segmentation, automated FFR-CT computation, and structured reporting help ease this burden.

Cardiolens® Platform will tackle both:

• AI‑driven FFR‑CT is intended to provide objective, quantitative hemodynamic metrics,
• A cloud-based diagnostic workflow is designed to integrate into PACS/RIS and cardiology planning tools.

Jacek Hławka, CEO of Hemolens Diagnostics, emphasizes the broader vision:

“This partnership marks a major milestone in our strategic roadmap for market expansion. The Voivodeship Specialist Hospital is not only one of the pioneers in digital cardiology but also an ideal partner for validating high-impact innovation in real-world clinical settings. Our mission is to digitize cardiac diagnostics – and this pilot is a critical first step in building a scalable foundation for broader adoption, both in Poland and globally.”

Looking ahead: scalability & broader impact

The pilot program reflects the global innovation trend of hospitals – startup partnerships, AI deployment, and data-driven, non-invasive diagnostics tailored to strategic guidelines.

As interventional cardiology and radiology evolve, demand for personalized imaging pipelines – from CCTA acquisition to AI-QCT to clinical decision – will only accelerate. Making these cutting-edge tools accessible to a new generation of physicians can be a trigger to foster fresh perspectives on the digital transformation of healthcare as well. The synergy of global guideline alignment, local pilot testing, and next‑gen AI platforms heralds a new era.

About Hemolens Diagnostics®

Hemolens Diagnostics® specializes in developing and delivering advanced solutions for noninvasive cardiac diagnostics. The company’s diagnostic platform may support healthcare professionals in making more informed decisions in the diagnosis and treatment of coronary artery disease.

Its potential applications may include reducing the number of unnecessary invasive procedures, improving operational efficiency in medical facilities, and optimizing the use of healthcare system resources.

Cardiolens Viewer® is intended for research purposes only (Research and Academic Use Only) and is not approved for diagnostic, therapeutic, or other medical use. Use of the software is at the user’s own risk, and the manufacturer shall not be liable for damages resulting from improper use, particularly involving its use to diagnose a particular patient. The software is not authorized for use as a medical device under Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017, on medical devices and has not been cleared or approved by the FDA.

Resources:

https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Chronic-Coronary-Syndromes

https://scct.org/page/Abstracts_SCCTGlobal2025

https://scct.org/news/685976/U.S.-CMS-agrees-to-double-reimbursement-for-cardiovascular-CT-services.htm

https://radiologybusiness.com/topics/healthcare-management/business-intelligence/medical-imaging-trends-watch-2025

https://scct.org/page/Guidelines

https://radiologybusiness.com/topics/healthcare-management/healthcare-policy/medicare-more-double-reimbursement-ccta-likely-spurring-greater-demand