NEW YORK – Avails Medical announced on Tuesday that it has received 510(k) clearance from the US Food and Drug Administration for its Equant workflow solution for antibiotic susceptibility testing (AST).
The fully automated system provides a standardized inoculum directly from positive blood cultures and can reduce routine AST turnaround times by up to one day, the Menlo Park, California-based company said in a statement. The system uses electronic biosensor technology that is designed to improve speed and accuracy in pathogen quantification and susceptibility testing directly from samples, it added.
According to the firm's website, the system can be used with any established AST systems and disk diffusion AST.
Avails CEO and Cofounder Oren Knopfmacher said in a statement that the firm has worked "diligently" to bring the Equant to the market to accelerate the current workflow for AST testing and improve patient care.
"Commercializing the Equant system is our first step towards achieving our mission of making rapid AST testing both affordable and accessible in all healthcare settings, significantly improving patient care and saving lives," he said.