BD GAINS 510(K) CLEARANCE OF AI SOFTWARE FOR MRSA DIAGNOSTICS

BD (Becton, Dickinson and Company) has announced 510(k) clearance from the U.S. Food and Drug Administration (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 labour- 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 a 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.

According to the CDC, MRSA in hospital settings can cause severe problems, from the bloodstream or surgical-site infections to sepsis and death. Performing a lab test is the only way to determine if a particular kind of infection is caused by MRSA, so the ability to run these tests efficiently and effectively may significantly impact patient treatment.

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.