Drawbridge Health, a healthcare technology company focused on reinventing the blood draw experience, 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 growing 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 one-of-a-kind, user-friendly lancet that allows individuals to obtain capillary whole-blood samples with a virtually painless, simple press of a button. The cutting-edge 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.
“We are continuing to build the ‘healthcare of tomorrow’ through unparalleled research and development, science, and technology,” said Jerome Scelza, Co-CEO of Drawbridge Health. “NanoDrop’s versatility, accuracy, and ease of use makes it an essential tool for healthcare professionals and consumers alike, including in a decentralized clinical trial setting. In an effort to make at-home blood sampling easier for patients in remote areas, for those in the field – including members of the armed forces, and healthcare providers running clinical trials, NanoDrop being cleared by the FDA for over-the-counter use allows us to meet commercial demands across multiple end markets.”
“We are excited about the commercial opportunities with NanoDrop from both the clinical research side and the consumer side,” said Dr. Nathan Price, Chief Scientific Officer of Thorne. “We look forward to incorporating these devices into our at-home testing kits in the future as we continue to see our customers wanting more and more access to personalized data to help them improve their health. We firmly believe this is the next step in revolutionizing the user experience across our at-home testing portfolio, and that it will be a game changer when it comes to the diversity of individuals we can reach through at-home testing, as well as product development at Thorne.”
