Avails Medical announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking eQUANTTM system. The eQUANT system is a leap forward in combatting antibiotic resistance, providing a standardized inoculum (0.5 McFarland equivalent) directly from positive blood cultures. The clinical data submitted to FDA demonstrated eQUANT's potential to reduce routine AST turnaround times by up to one day, meeting the high hurdle of over 95% correlation to standard of care methods.
The eQUANT system is differentiated by its compact design, intuitive interface, and cost-effectiveness, qualities that position it well for broad adoption across a range of healthcare environments, including community hospitals.
Avails Medical also announced the appointment of Michael Blitz as Executive Vice President for Commercialization and Business Development. Mr. Blitz has more than 20 years of experience in the infectious disease IVD space bringing novel technologies to the market. He recently helped commercialize the Karius test and previously held commercial leadership positions at GenePOC, Nanosphere and Meridian Bioscience. "We are pleased to welcome Mike to our executive team at this important juncture and looking forward to accelerating our entry into the AST market", said Dr. Knopfmacher.
