LBT Innovations completes CE mark certification for APAS

LBT Innovations, an Australian-listed medical technology company, and joint venture company Clever Culture Systems AG (CCS) have completed a comprehensive essential requirements review of the extensive documentation and data packs related to the APAS technology and certify requirements are met for CE Marking.

Completing this process means that the company has de-risked its regulatory path to market in all the key markets: North America, Europe and Australia and New Zealand.

The process required LBT and CCS's internal engineering and quality teams to work closely with regulatory consultants to complete a thorough checklist to ensure all requirements were met, said LBT CEO and Managing Director Brent Barnes. "We are satisfied that given the exhaustive and rigorous testing and data, including a 10,000-patient international clinical trial which supported the FDA clearance, we meet the requirements for CE Mark certification."

APAS is an unclassified, self-declarable in vitro diagnostic (IVD) medical device in Europe and can subsequently be CE marked by the manufacturer once a signed Declaration of Conformity is completed which states all of the necessary safety and performance evidence (data) is met, to support compliance with European regulatory requirements. APAS is an artificial intelligence technology for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation. The US FDA-cleared device is based on LBT’s Australian-developed intelligent imaging and interpretative software and based in a unit about the size of a large photocopier.