BD gains 510(k) clearance of AI software for MRSA diagnostics 

May 16, 2023 – BD announced 510(k) clearance from the FDA for the new BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) imaging application that uses artificial intelligence (AI) to interpret bacterial growth and release negative specimens with minimal human interaction. 

The BD Kiestra™ MRSA application uses AI to automate the traditionally labor- and time-intensive task of inspecting Petri dishes to determine if there is bacterial growth or not, enabling medical laboratory scientists and technicians to spend more time on higher value analysis. The application can evaluate single specimens or group together the large volume of plates with non-significant growth for batch review and release of negative results which may help reduce the administrative burden on technicians. 

The MRSA imaging application uses AI algorithms to look for specific culture characteristics on the BBL™ CHROMagar™ MRSA II plate. Based on that information and analysis by BD Synapsys™ informatics, plate images are automatically organized and sorted into meaningful worklists for laboratory scientists and technicians. 

The AI-based imaging application is backed by the BD BBL™ CHROMagar™ MRSA II screening plates and powered by BD Synapsys™ Informatics Solution, and can be used with both standalone BD Kiestra™ ReadA systems as well as track-based BD Kiestra™ laboratory automation solutions. 

BD Kiestra™ Solutions provide total lab automation for the clinical microbiology laboratory. These solutions are designed to enhance laboratory operations, increase financial efficiencies and advance laboratory operations. BD Kiestra™ lab automation offerings include scalable and modular microbiology workflow automation solutions, ranging from standalone units to fully automated track-based automation systems for mid- and high-volume labs. Learn more about BD Kiestra. 

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