FDA clears novel blood collection device
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Key takeaways:
- The BD MiniDraw device is part of a blood testing collection system that is designed to make routine blood tests less invasive.
- The blood testing collection system will be marketed in 2024.
The FDA has cleared BD MiniDraw, a capillary blood collection device developed by Babson Diagnostics and Becton, Dickinson and Company that allows clinicians to collect blood without a phlebotomist, according to a company press release.
BD MiniDraw is part of Babson’s BetterWay blood testing system, which uses a “pea-sized amount of blood” from a fingertip and delivers results that are comparable to traditional blood tests, the release said.
The BetterWay blood testing system is designed to make routine blood tests less invasive and will support primary care clinicians “in managing a range of chronic conditions, such as diabetes, cholesterol, heart disease and kidney disease, to name a few,” David Stein, PhD, CEO of Babson Diagnostics, told Healio. The 501(k) clearance of BD MiniDraw paves the way for the commercialization of BetterWay in 2024.
“BetterWay was created with the clinician in mind and offers routine blood testing to support annual wellness exams, condition management and screenings,” he said. “The BetterWay launch menu will offer 80% of the most commonly ordered blood tests, including complete blood count, comprehensive metabolic panel, a broad lipid panel, HbA1c and more. The menu supports clinician ordering for diagnosis and treatment and uses existing CPT codes to enable payers to easily cover the tests.”
BetterWay has been tested in more than 30 institutional review board-approved studies with thousands of study participants, Stein said.
“We conducted method comparison of conventional venipuncture collection and novel finger capillary collection to validate accuracy to ensure BetterWay blood testing service can deliver results equivalent to traditional methods,” he said.
According to Stein, the blood collection experience has “remained largely unchanged over the past 70 years.”
“BetterWay will help address the ongoing shortage of health care professionals as well as the increasing need to expand access and reduce health care costs,” he said in the press release. “Our mission is to deliver a better experience at convenient locations, with easy-to-understand, medically accurate results trusted by clinicians.”