LeadBD Receives FDA Clearance for Fingertip Blood Collection Device

BD Receives FDA Clearance for Fingertip Blood Collection Device

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Franklin Lakes, NJ – BD (Becton, Dickinson, and Company), a prominent global medical technology company, has secured 510(k) clearances from the U.S. Federal Drug Administration (FDA) for its innovative blood collection device, the BD MiniDraw™ Capillary Blood Collection System. This novel system obtains blood samples from a fingerstick, delivering lab-quality results for commonly ordered blood tests.

The BD MiniDraw™ System presents a less invasive alternative to traditional venous blood draws, utilizing capillary blood collected from a patient’s finger by a trained healthcare worker. Also, This eliminates the need for a phlebotomist to draw blood from a vein, providing a more convenient and accessible option for patients. The system’s design allows lab-quality blood test results from a fraction of the volume required in traditional venous collections.

Moreover, The 510(k) clearances encompass low-volume blood collection for a lipid panel, selected chemistry tests, and hemoglobin and hematocrit (H&H) testing. These tests, are vital for diagnosing and monitoring various chronic conditions, including hypertension and high cholesterol. BD anticipates expanding the range of blood tests facilitated by the BD MiniDraw™ Collection System in the future.

“BD has a 125-year history of transforming health care and expanding access to critical health innovations and technologies,” said Bridget Bagnato, worldwide president of Specimen Management for BD. “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.”

However, The innovation is seen as a step towards transforming the traditional blood testing experience. Instead of requiring patients to visit dedicated laboratory service centers, the BD MiniDraw™ Collection System opens possibilities for blood testing in new, more convenient locations, including retail pharmacies.

Also Read: BD Names Dr. Ronald Silverman as Chief Medical Officer

Furthermore, The system’s introduction aims to benefit patients, healthcare providers, and collection sites by offering a more convenient and less invasive blood testing option. BD’s strategic partnership with Babson Diagnostics, announced in May 2022, supports the development of the Babson BetterWay™ blood testing ecosystem, incorporating the BD MiniDraw™ Collection System and Babson’s proprietary technologies for automated sample handling and analysis. This collaboration seeks to enable blood testing with a fraction of the sample volume required by traditional methods without compromising quality or accuracy.

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