Deliverables
Based on Deliverable 2.2. the new aQuant code and infrastructure will be tested at selected hospitals in Europe and validated according to EU regulatory standards as well as operational specifications defined in deliverable 2.1.
Founded on deliverable 31 the subsequent focus is to apply for and achieve regulatory approval for the MedTrace solution in the EU in the form a CEmark as medical device of the software and the medical device part of the hardware
3.1 Clinical Study EU"In order to approve the MedTrace solution as medical device, the company needs to carry out a minor clinical study using 15O-water in cardiac patients to prove safety and efficacy. Part of this study is to purchase already existing data from Amsterdam University Medical Centers from a recent similar clinical trial. In parallel the clinical study will be prepared (study protocol, site recruitment, clinical trial agreements and patient recruitment) End deliverable is ""last patient scanned""."
Publications
Author(s):
Susanne Hansen, Jeppe Madsen, Shakti Nicolai Johansen, Charlotte Jensen, Lone Winkler, Lars Gormsen and Lars Tolbod, ,
Published in:
Journal of Nuclear Medicine, Issue May 2021, 62 (supplement 1), 2021, Page(s) 3001, ISSN 2047-2412
Publisher:
SNM
Author(s):
Mette Kjaerulff, Simon Madsen, Kirsten Bouchelouche, Lars Gormsen and Lars Tolbod
Published in:
Journal of Nuclear Medicine, Issue May 2021, 62 (supplement 1), 2021, Page(s) 1632
Publisher:
SNMMI
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