Drawbridge Health today announced that its at-home, patented blood sampling device, NanoDrop, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Over-the-Counter use. The clearance of this novel dual nano-lancet technology expands a suite of products that already includes the OneDraw Collection System, cleared by the FDA as a Class II medical device to collect blood samples to measure HbA1c for monitoring the long-term control of blood sugar (glucose) in diabetic individuals.
NanoDrop is a lancet that allows individuals to obtain capillary whole-blood samples with a press of a button. The technology makes whole-blood sampling and at-home health monitoring both convenient and simple for healthcare professionals and consumers alike.
The FDA clearance accelerates opportunities in large-scale clinical trials that have hard-to-reach participant populations, as well as increases patient accessibility in remote monitoring healthcare settings. Small sample capillary blood-testing advancements enable greater convenience and overall compliance in important diseases, such as diabetes, metabolic disorders and infectious disease.
