MedTrace announced that its medical device software aQuant has been CE marked, a significant milestone in the company’s mission to make 15O-water readily available and eliminate diagnostic uncertainty.
MedTrace, an innovator in PET diagnostic imaging, today announced with great anticipation that it has CE-marked its aQuant software, bringing the company one step closer to achieving its mission.
aQuant is a post-processing and analysis software tool made for positron emission tomography (PET) myocardial perfusion imaging (MPI). aQuant aids physicians in diagnosing patients with suspected or known coronary artery disease (CAD), through quantification and visualization of myocardial blood flow (MBF).
“Receiving CE marking for aQuant is more than a regulatory achievement — it’s proof that our vision of eliminating diagnostic uncertainty and making 15O-water a widely adopted diagnostic tracer is taking shape. This milestone brings us one important step closer to commercialization,”
says MedTrace’s CEO, Peter Juul Kristensen, and adds:
“We are committed to driving clinical adoption by continuously expanding the range of medical indications supported by our technology.”
Head of software development at MedTrace, Mark S. Gockenbach Jr., who has been part of the development of aQuant from the beginning says:
“This is a really great piece of software and I’m excited to see it help improve care for many patients. But more than that, this milestone highlights that we as an organization can build and release medical device software. It can’t be overstated how proud I am of our team.”
MedTrace’s vision is to unlock the clinical potential of 15O-water. With CE marking now achieved, the company can prepare for broader clinical applications beyond cardiology. While today’s approval covers coronary artery disease, the roadmap includes future indications in neurology, oncology, and additional cardiology subfields.
This forward-looking pipeline is supported by advances in full-body PET scanners, computing power, and artificial intelligence, which together create nearly limitless opportunities for new clinical applications.
Erik Strömqvist, Chairman of the Board, says about the CE-mark:
“Receiving the CE mark for aQuant is a proud milestone for MedTrace and a strong validation of our technology and our dedicated team. It marks the beginning of a new chapter where we can bring the benefits of quantitative PET imaging to more patients and sets a solid foundation for future growth and commercialization.”
Back in April 2025, the company received a positive response from the Danish Medicines Agency, granting an exemption for the installation of aQuant at two hospitals in Denmark – Aarhus University Hospital (AUH) and Regional Hospital Gødstrup – ahead of the final CE-marking.
About MedTrace
Founded with a vision to revolutionize diagnostic imaging, MedTrace specializes in radiopharmaceuticals with an ultra-short half-life and is at the forefront of making 15O-water available for clinical practice. The company’s ongoing Phase III clinical trial in the United States is evaluating the diagnostic accuracy and safety of 15O-water as a tracer for PET scans in patients with suspected coronary artery disease. MedTrace products are currently not cleared to market in the US.
MedTrace’s innovative technology is already in use in Denmark under magistral exemption and exemption from CE marking issued by the Danish Medicines Agency. The clinical practice at Rigshospitalet in Copenhagen and Aarhus University Hospital in Aarhus has demonstrated the technology’s potential, with the Aarhus University Hospital having scanned over 3,000 patients using 15O-water produced by MedTrace’s system.
For more information, please contact:
Sandra Meersohn Meinecke
[email protected]
+45 53 56 51 61
