Drawbridge Health’s NanoDrop gains FDA clearance for at-home blood sampling

April 04, 2024 - Drawbridge Health, a pioneering healthcare technology company, announced an innovative achievement today as its advanced at-home blood sampling device, NanoDrop Lancet, received United States Food and Drug Administration (FDA) 510(k) clearance for over-the-counter (OTC) use. This marks a significant milestone in the healthcare industry, as NanoDrop becomes the first OTC blood-lancing device labeled for the upper arm to be cleared in the US.

NanoDrop, leveraging a novel dual nano-lancet technology, significantly advances healthcare accessibility and convenience. Unlike traditional blood sampling methods that often involve discomfort and inconvenience, NanoDrop allows individuals to obtain painlessly capillary whole-blood samples with a simple button press. This cutting-edge technology simplifies blood sampling and opens new avenues for at-home health monitoring for healthcare professionals and consumers.

The FDA clearance of NanoDrop holds immense implications for various sectors within the healthcare industry. It paves the way for expanded opportunities in large-scale clinical trials with hard-to-reach participant populations and enhances patient accessibility in remote monitoring healthcare settings. Furthermore, advancements in small sample capillary blood testing facilitated by NanoDrop contribute to greater convenience and compliance in managing critical diseases such as diabetes, metabolic disorders, and infectious diseases.

Jerome Scelza, Co-CEO of Drawbridge Health, expressed enthusiasm about the potential impact of NanoDrop on healthcare. "We are continuing to build the 'healthcare of tomorrow' through unparalleled research and development, science, and technology," Scelza stated. "NanoDrop's versatility, accuracy, and ease of use make it an essential tool for healthcare professionals and consumers alike, including in a decentralized clinical trial setting."

Nathan Price, PhD, MS, Chief Scientific Officer of Thorne, highlighted the commercial opportunities presented by NanoDrop. "We are excited about the commercial opportunities with NanoDrop from both the clinical research and consumer sides," said Price. "We look forward to incorporating these devices into our at-home testing kits as we continue to see our customers wanting more and more access to personalized data to help them improve their health."

The FDA clearance of NanoDrop signifies a significant milestone in healthcare technology, promising to revolutionize the user experience across at-home testing portfolios and expand access to personalized healthcare data for individuals worldwide. As Drawbridge Health and its partners continue to innovate, the landscape of at-home consumer testing and decentralized clinical trials is poised for transformative change, ushering in a new era of healthcare accessibility and convenience.