The FDA cleared Clever Culture Systems’ artificial intelligence tech for automated imaging, analysis and interpretation of microbiology culture plates, which can accelerate the diagnosis and reporting of infectious diseases.
Switzerland-based Clever Culture Systems is a joint venture between Hettich AG and Australia’s LBT Innovations. The de novo submission of the Automated Plate Assessment System, or APAS, earned 510(k) clearance, and will be regulated as a Class II medical device, according to a statement.
“It’s a very sophisticated set of algorithms and microbiology decision support system that thinks about the culture plate the same way as a microbiologist does,” said former LBT Innovations CEO Lusia Guthrie in a video. APAS can read a culture plate in about 20 seconds, compared with the minute it would take a microbiologist, the company said. The quicker diagnosis will result in the appropriate antibiotic being prescribed up to 6 hours earlier than with current best practices, LBT said.
The FDA nod comes on the strength of a series of clinical trials that used a manual version of APAS to test 10,000 patients over a 12-month period. The trials took place in Australia and the U.S.
Clever Culture Systems is in discussions with diagnostics companies for the licensing of its APAS products.