Drawbridge Achieves FDA 510(k) Clearance for NanoDrop At-Home Blood Sampling Device
3 April 2024
Drawbridge Health, a pioneering healthcare technology company focused on revolutionizing the blood draw experience, announced today a significant achievement: its innovative at-home blood sampling device, NanoDrop, has obtained FDA 510(k) clearance for Over-the-Counter use. This marks a pivotal moment for Drawbridge, expanding its product offerings alongside the FDA-cleared OneDraw Collection System, designed for monitoring HbA1c levels in diabetic individuals.
NanoDrop stands out with its cutting-edge dual nano-lancet technology, offering a nearly painless method for collecting capillary whole-blood samples. With a simple press of a button, individuals can effortlessly obtain accurate samples, making at-home health monitoring and whole-blood sampling more accessible and convenient for both healthcare professionals and consumers.
The FDA clearance not only validates NanoDrop's safety and efficacy but also opens doors for broader applications. Large-scale clinical trials, particularly those involving hard-to-reach participant populations, can now benefit from the ease and reliability of NanoDrop. Moreover, the clearance enhances patient accessibility in remote monitoring healthcare settings, contributing to improved healthcare outcomes.
Advancements in small sample capillary blood testing have profound implications for disease management, including diabetes, metabolic disorders, and infectious diseases. NanoDrop's versatility, precision, and user-friendly design make it an indispensable tool for healthcare professionals and consumers alike, especially in decentralized clinical trial settings.
With FDA clearance for Over-the-Counter use, NanoDrop addresses a growing need for convenient at-home blood sampling solutions across various markets. It aims to simplify the blood sampling process for individuals in remote areas, field personnel such as members of the armed forces, and healthcare providers conducting clinical trials, thereby advancing healthcare accessibility and patient care.
Source: prnewswire.com
