It appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm.

Selux Diagnostics Inc. received U.S. FDA 510(k) clearance for its next generation phenotyping (NGP) system, a rapid antibiotic susceptibility test (AST) platform that determines a bacteria’s susceptibility to 14 specific antimicrobial agents in less than six hours. Prompt identification of the narrowest effective antimicrobial for an infection is critical to the battle to preserve the efficacy of critical antibiotics and slow the development of ‘superbug’ infections.

Another company has entered the fray in the eternal battle between humans and bacteria. Day Zero Diagnostics Inc. aims to produce whole genome sequencing-based diagnostic technologies that quickly identify the species and antibiotic resistance profile of bacterial pathogens from a blood sample. In a vote of confidence that the company is on the right track, the global non-profit Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) awarded Day Zero another $8.2 million. The latest funding pushes Day Zero’s awards from CARB-X over $16 million.

Becton, Dickinson and Co. and Accelerate Diagnostics Inc. joined forces to knock out sepsis and put patients on the path to recovery in hours, not days.