Biomomentum, a provider of orthopedics solutions, has obtained CE mark approval for its hand-held arthroscopic probe, Arthro-BST.
The Arthro-BST is used in conjunction with arthroscopic procedures for the non-destructive measurement of compression-induced streaming potentials which are created during gentle compression of the articular cartilage and also calculates a quantitative parameter reflecting its electromechanical properties.
Biomomentum said its production quality assurance system’s technical file which has been reviewed by AMTAC Certification Services (Intertek) conforms to the provisions of the UK national legislation, transposing Annex V of the Directive 93/42/EEC on medical devices.
The company also received medical device license fom Health Canada following an ISO 13485:2003 audit of its Quality Management System by Intertek.
Biomomentum co-founder and CEO Eric Quenneville said these were major milestones for the Arthro-BST and they are very proud of the accomplishments.