MELBOURNE, Australia & SAN DIEGO — Nutromics is building a wearable lab-on-a-patch™ for continuous molecular monitoring. Today the company has announced that the FDA has granted Breakthrough Device Designation (BDD) for its first product in development - a wearable for vancomycin therapeutic drug monitoring.
The FDA’s Breakthrough Device Program is designed to bring promising new medical technologies to patients sooner by accelerating development and regulatory engagement and reviews. The designation is reserved for technologies that address life-threatening or irreversibly debilitating conditions and that have also demonstrated a likelihood of providing for more effective treatment or diagnosis. The patch is currently for investigational use only and has not been authorized for commercial distribution by the FDA.
Nutromics’ first product in development is a patch designed to support vancomycin therapeutic drug monitoring. Approximately 2.9 million patients in the US receive vancomycin therapy every year. This antibiotic is used to treat life-threatening conditions like sepsis. In 2020, vancomycin dosing guidelines were published that recommended area under the curve dosing over trough monitoring.