Exemption granted paves the way for early hospital implementation of aQuant.
MedTrace has received a positive response from the Danish Medicines Agency, granting exemption for the installation of its imaging software, aQuant, at two hospitals in Denmark – AUH and Region Hospital Gødstrup – ahead of final CE marking.
“This exemption marks a significant step forward for MedTrace, bringing us closer to making to a final aQuant widely available for clinical use,” says CEO Ann Kristin Led.
aQuant is a software suited for the semi-automated and robust analysis of 15O-water. The underlying algorithms of aQuant have been used in research and reported in more than 30 peer-reviewed articles over the last decade.
aQuant will, when cleared to market, offer analysis of the quantitative myocardial blood flow during PET exams with 15O-water.
// MedTrace’s technologies are not cleared to market for routine clinical use and are only available for use where an exemption has been granted by the relevant national authority.
Contact:t:
René Duvander
Director, Market Development
rene@medtrace.dk
About MedTrace
MedTrace is a pharma and medical device company with a 15O-water point-of-care solution under development. The solution consists of patented hardware for on-demand manufacturing, dosing, and infusion of 15O-water and patented software to analyze PET images. The company has an ongoing Phase III Clinical Trial, RAPID-WATER-FLOW, that seeks to evaluate the diagnostic accuracy and safety of 15O-water as a myocardial perfusion PET imaging agent.
