NEW YORK (GenomeWeb News) – Bioinformatics company Cartagenia today announced it received a Canadian medical establishment license for its Cartagenia Bench platform.
The platform is a cloud-based software product for the analysis, interpretation, reporting, and sharing of genomic variants in routine clinical diagnostics. It is CE marked, registered with the US Food and Drug Administration as an exempt Class I Medical Device, and registered in Europe also as a Class I Medical Device, Cartagenia said.
The platform was build under a certified ISO 13485 Medical Device Quality Management System.
Cartagenia CEO Herman Verrelst said that the license will open up "the important and growing Canadian market for Bench."