161010 CCS FDA media release_final - 1
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The FDA has cleared Clever Culture Systems' APAS® as a Class II medical device. APAS® is an artificial intelligence technology that uses imaging and software to automatically image, analyze, interpret and report the results of microbiology culture plates. It was tested in clinical trials involving 10,000 patients in Australia and the US over 12 months, matching or exceeding the accuracy of microbiologists. Clever Culture Systems plans to launch APAS® Independence, an automated standalone plate reader, in 2017 followed by the integrated APAS® Incubot. This FDA clearance is an important step in making APAS® available to clinical microbiology laboratories worldwide.
161010 CCS FDA media release_final - 1
- 1. MEDIA RELEASE US FDA GRANTS CLEARANCE FOR CLEVER CULTURE SYSTEM’S APAS® FDA clears APAS® imaging and software technology as a Class II medical device BÄCH, Switzerland: 10th October, 2016: Clever Culture Systems AG (CCS), the Swiss-based joint venture between Australian medical technology company LBT Innovations Limited (ASX: LBT) and Hettich AG (Switzerland) has received clearance of its 510(k) de novo submission to the US Food and Drug Administration (FDA) for APAS® as a Class II medical device. APAS® (Automated Plate Assessment System) is a breakthrough artificial Intelligence technology for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation. APAS® enables laboratory efficiency in addition to the faster diagnosis and reporting of infectious diseases. Developed by LBT Innovations, APAS® has been licensed on a global, exclusive basis to CCS, which is integrating APAS® with laboratory robotic instrumentation. CCS plans to bring APAS® to market in 2017 as an automated stand-alone plate reader (APAS® Independence) closely followed by the integrated incubator (APAS® Incubot). The 510(k) de novo submission used a manual version of APAS® to test 10,000 patients in a series of clinical trials conducted in Australia and the US over a 12-month period. In each trial, APAS® achieved its target primary endpoints and the results matched or exceeded the findings of a panel of experienced microbiologists. Mr Peter Bradley General Manager of CCS said, “Rigorous analysis by the FDA has resulted in CCS being given clearance for the manual version of the APAS® instrument. This is a tribute to the robust nature of the technology and the hard work of our clinical trial partners and our team of microbiologists and image analysis specialists. We believe APAS® technology is going to make a significant difference to the efficiency of microbiology laboratories globally” Mrs Lusia Guthrie (Chairman of CCS), confirmed that CCS is in continuing discussions with significant global diagnostics companies for the licensing of the APAS® product portfolio, including APAS® Independence and APAS® Incubot, plus flow-on product opportunities on the drawing board all aimed at the clinical microbiology laboratory. Mr Klaus-Gϋnter Eberle CEO and owner of Andreas Hettich GmbH started “We are delighted by this result. This is another stepping stone to getting our APAS® based instruments into microbiology laboratories and making a difference to patient outcomes”. --ENDS— CONTACT Peter Bradley General Manager, Clever Culture Systems AG (CCS) Tel: +61 (0)8 8227 1555, Mobile +61 (0)428 115 914 E: pmb@cleverculturesystems.com