BD earns FDA 510(k) clearance for bacteria-detecting AI software

BD has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its software that can help detect bacterial growth, the Franklin Lakes-based medical technology company announced May 16.

The new BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) imaging application uses artificial intelligence to automate what BD describes as the “traditionally labor- and time-intensive task of inspecting Petri dishes to determine if there is bacterial growth,” allowing technicians to spend time on higher value analysis. 

According to the FDA, 510(k) clearance deems a submitted device as safe and effective – or substantially equivalent – as a legally marketed device. 

“The pandemic created significant and ongoing labor challenges in laboratories, and reading plates is a labor-intense, potentially error-prone process in microbiology,” Nikos Pavlidis, vice president and general manager for diagnostics at BD, said in a statement.  

Pavlidis added that the new imaging application “helps use limited laboratory staff more efficiently and allows lab personnel to bring their expertise to bear on more critical and complex specimens.” 

MRSA can cause a staph infection that is difficult to treat because of resistance to some antibiotics, according to the Centers for Disease Control and Prevention. In a hospital setting, this can have severe and sometimes fatal consequences.  

“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,” according to BD. 

According to a recent assessment by The Leapfrog Group, which ranks health care centers on areas such as safety, hospital-acquired infections such as MRSA remain high. New Jersey Health Care Quality Institute President and CEO Linda Schwimmer urged New Jersey hospitals to “double down on their focused efforts to reduce” these infections. 

By using AI algorithms, BD’s imaging application, supported by other BD innovations, can work to achieve that goal.