Photon Counting CT in Cardiac Imaging Not Yet Recruiting Trial Signals Regulatory Readiness Sponsored by Dr Ronny R Buechel

A not yet recruiting trial of photon counting computed tomography for advanced cardiac imaging moves into clinical evaluation, signaling regulatory aware progress for this imaging technology.

Publication date context: February 15, 2026. The study focuses on coronary artery disease and uses a device described as photon counting computed tomography. The sponsor listed is Ronny R Buechel, MD, and the public record is hosted on ClinicalTrials.gov with the identifier NCT07411196 and the page accessible at the provided link. This report summarizes what is publicly disclosed about the trial as of that date and sets the stage for regulatory minded discussion among clinicians and device developers.

What changed in cardiac imaging with photon counting CT?

Photon counting computed tomography represents a computed tomography approach that uses detectors capable of counting individual photons during image acquisition. In the context of cardiac imaging the technology promises sharper edges, better tissue differentiation and the potential for dose management improvements compared with conventional CT. The public trial record confirms the investigation centers on coronary artery disease and that the study is in a not yet recruiting status. The listing identifies Ronny R Buechel, MD as the sponsor and provides a public reference to the clinical trials registry entry NCT07411196. While the public data do not include early results, the record demonstrates a regulatory aware path for device evaluation in a cardiac setting.

Intended use and study scope

The registry description frames the work as a device evaluation in the cardiac imaging space. While the exact performance metrics are not disclosed in the record, the intent is to investigate how photon counting CT can support imaging of the heart in patients with suspected or known coronary disease. The not yet recruiting status indicates that enrollment has not begun and that the study is likely in planning or regulatory preparation phases. Stakeholders should monitor the registry for upcoming milestones and any changes in recruitment status or study milestones.

What are the regulatory implications for this device and the trial?

Regulatory considerations for a photon counting CT device used in cardiac imaging center on ensuring clear statements about intended use, performance expectations and safety. The trial entry aligns with a framework where documentation under regulatory schemes such as the MDR may be necessary for future submissions. Stakeholders should anticipate the need for robust technical data, safety assessments and claims substantiation as the study progresses toward clinical use. Observers should track the trial registry and the sponsor communications for updates on milestones that could precede a formal regulatory submission.

Regulatory path and upcoming steps

The path is likely to include continued registry updates, potential amendments and eventual transition to broader clinical evaluation with appropriate approvals. As results become available or as recruitment begins, stakeholders will look for evidence of device performance, safety data and alignment with the declared intended use. Regulatory minded readers should plan for a phased data package and ongoing compliance documentation as the project evolves.

Device description and trial context

The device at the center of this record is photon counting computed tomography, a modality that uses detectors designed to count individual photons to create diagnostic images. In this clinical setting the technology is being evaluated for its possible role in improving cardiac imaging for patients with coronary artery disease. The trial is led by sponsor Dr Ronny R Buechel and is listed as not yet recruiting in the public registry. Publicly available information on the ClinicalTrials.gov entry provides the study identifier and link to the registry page for those seeking direct documentation of the trial parameters.

Potential benefits and safety considerations

Because this is an early stage evaluation there are no published clinical results available in the public record. The regulatory focus remains on accurate representation of the device function and intended use as well as a careful assessment of patient safety aspects. Clinicians and regulators should look for forthcoming data on image quality, dose considerations and practical use in routine imaging workflows as the study progresses.

Sponsor and funding

The trial is sponsored by Ronny R Buechel, MD, reflecting physician leadership in the exploration of photon counting CT for cardiac imaging. Disclosure of funding details is limited in the public record, which underscores the importance of transparent reporting and compliance with applicable regulatory requirements as the study advances. The sponsorship note highlights the role of clinician researchers in advancing novel imaging technologies within regulated pathways.