BD Gains 510(k) Clearance of Artificial Intelligence Software for MRSA Diagnostics

BD Kiestra™ MRSA Imaging Application Helps Enhance Microbiology Laboratory Efficiency and Workflow

FRANKLIN LAKES, N.J., May 16, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today 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 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 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, vice president and general manager 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."

According to the CDC, MRSA in hospital settings can cause severe problems, from blood stream 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 have significant impact on 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.

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.

BD Synapsys™ Informatics Solution is a lab connectivity and workflow management solution, supporting integrated diagnostic processing, automated decision support and on-demand insights to address laboratory challenges and help improve outcomes.  The informatics tools empower laboratory staff to impact turnaround time, expedite decision-making, improve productivity and support their compliance requirements. BD Synapsys™ Informatics Solution allows labs to analyze their performance using microbiology informatics through a single, advanced platform with an intuitive, personalized user interface. BD Synapsys™ Informatics was among the first life science diagnostics informatics platforms to receive the Underwriters Laboratory Cybersecurity Assurance Program certification, an independent third-party evaluation that uses standardized, testable criteria for assessing software vulnerabilities and weaknesses. Learn more about BD Synapsys™

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 77,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.

SOURCE BD (Becton, Dickinson and Company)