FDA clears automated imaging AI that speeds up infectious disease Dx

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.

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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.

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