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Home » FDA clears AI software for MRSA diagnostics from BD

FDA clears AI software for MRSA diagnostics from BD

May 16, 2023 By Sean Whooley

BD Kiestra MRSA imaging application with AI artificial intelligence
The BD Kiestra MRSA imaging app powered by AI. [Image courtesy of BD]
BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its new Kiestra imaging application that uses AI.

The Kiestra methicillin-resistant staphylococcus aureus (MRSA) imaging application uses AI to interpret bacterial growth and release negative specimens with minimal human interaction.

Franklin Lakes, New Jersey-based BD designed the Kiestra MRSA application to utilize AI to automate this inspection process. These traditionally require labor- and time-intensive inspections of Petri dishes to determine if bacterial growth occurred. With Kiestra’s automation capabilities, scientists and technicians can spend more time on higher-value analysis.

BD said in a news release that the application can evaluate single specimens or group together large volumes. That could help reduce the administrative burden on technicians, the company added.

The MRSA imaging application looks for specific culture characteristics on the BBL CHROMagar MRSA II plate. BD’s application then couples that information with analysis from the BD Synapsys informatics platform. It then automatically organizes and sorts plate images into meaningful worklists.

Performing lab tests represents the only option for determining a particular infection caused by MRSA, BD said. Enabling the efficient, effective running of these tests, could significantly impact the subsequent treatment.

“The pandemic created significant and ongoing labor challenges in laboratories, and reading plates is a labor-intense, potentially error-prone process in microbiology,” said Nikos Pavlidis, VP and GM for diagnostics at BD. “The use of this imaging application to automatically organize specimens in meaningful worklists helps use limited laboratory staff more efficiently and allows lab personnel to bring their expertise to bear on more critical and complex specimens.”

Filed Under: 510(k), Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Health Technology, Imaging, Regulatory/Compliance, Software / IT Tagged With: BD, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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