BD's Innovative Fingertip Blood Collection Device Receives FDA 510(k) Clearance, Signaling a Healthcare Transformation

8 December 2023

BD, a leading global medical technology company, has recently secured 510(k) clearances from the U.S. FDA for its groundbreaking BD MiniDraw™ Capillary Blood Collection System. This innovative device allows for less intrusive blood collection through fingersticks, delivering high-quality results for commonly requested blood tests. Unlike traditional methods, this system, administered by trained healthcare professionals, eliminates the need for a phlebotomist to draw blood from a vein, offering enhanced convenience for patients.

The design of the BD MiniDraw™ System produces lab-quality results with a smaller blood volume compared to traditional approaches, promising a better patient experience and the potential to revolutionize diagnostic testing. The recently obtained 510(k) clearances cover low-volume blood collection for lipid panels, selected chemistry tests, and hemoglobin and hematocrit (H&H) testing—essential components in diagnosing and monitoring various chronic conditions.

Beyond the confines of traditional lab environments, this system facilitates blood collection in non-traditional settings such as retail pharmacies, contributing to improved health equity and accessibility. BD's future plans involve expanding the scope of blood tests supported by the BD MiniDraw™ Collection System, allowing for convenient and less invasive blood draws at locations like local pharmacies or grocery stores. This approach aims to boost patient adherence to blood testing, enabling earlier diagnosis and more effective monitoring of chronic conditions, ultimately enhancing overall healthcare outcomes.

Source: prnewswire.com