BD secures FDA 510(k) approval for BD MiniDraw capillary blood collection system

2023-12-08

The BD MiniDraw capillary blood collection system is designed to provide lab-quality blood testing for the diagnosis of chronic conditions, from less invasive methods compared to venous collection and in more convenient locations The BD MiniDraw Capillary Blood Collection System obtains blood samples from a fingerstick. (Credit: Credit: BD) US-based medical technology company BD has received the US Federal Drug Administration (FDA) 510(k) approval for its BD MiniDraw capillary blood collection system. The MiniDraw system is designed to collect blood samples from a fingerstick to help produce lab-quality results for some of the commonly ordered blood tests. It is intended for low-volume blood collection for a lipid panel, select chemistry tests, and haemoglobin and hematocrit (H&H) testing, for diagnosis of chronic conditions. BD said that its MiniDraw capillary blood collection system provides a sample that produces lab-quality blood test results from a fraction of what is required for traditional venous collections. It is less invasive than traditional venous blood collection methods, more convenient for the patients, and eliminates the need for a phlebotomist to collect blood from a vein. BD intends to expand the blood tests compatible with its MiniDraw collection system in the future, as part of its strategic partner Babson’s BetterWay blood testing service. BD life sciences president and executive vice president Dave Hickey said: “Because the BD MiniDraw Collection System enables blood collection at non-traditional sites that may be more convenient, like your local pharmacy rather than a standalone lab, we can expand health equity and access, and make it easier for patients to get the blood tests they need both for preventative care and the management of chronic conditions. “This innovation is our strategy and pipeline coming to life, and proof of our commitment to enabling diagnostics and care in alternate settings.” When a patient requires blood work, a doctor orders the test, and a nurse or phlebotomist at a laboratory service centre will draw tubes of blood from the patient’s vein. BD said that its MiniDraw collection system can expand blood testing to new, more convenient settings that benefit patients, healthcare providers and collection sites. In May last year, the medical technology company extended its existing strategic partnership with Babson Diagnostics, which was initiated in 2020. The expanded collaboration focuses on BetterWay blood testing ecosystem, which includes the BD MiniDraw collection system and Babson’s automated sample and analytical technologies. BD specimen management worldwide president Bridget Bagnato said: “BD has a 125-year history of transforming health care and expanding access to critical health innovations and technologies. “Consumers want more convenience, a better experience and to take more control over their health. We believe the BD MiniDraw™ Collection System is potentially a game-changing innovation that combines convenience and better patient experience with lab-quality results.” Last month, BD rolled out the PIVO Pro Needle-free Blood Collection Device, a new needle-free blood draw technology in the US, designed to be compatible with integrated catheters.

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