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MedEdge MEA > Medical Equipment > BD Receives FDA Clearance for Fingertip Blood Collection Device
Medical EquipmentLeadNews

BD Receives FDA Clearance for Fingertip Blood Collection Device

ME Desk
ME Desk
Published: December 9, 2023
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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 MiniDrawโ„ข Capillary Blood Collection System. This novel system obtains blood samples from a fingerstick, delivering lab-quality results for commonly ordered blood tests.

The BD MiniDrawโ„ข 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 MiniDrawโ„ข 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 MiniDrawโ„ข 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 MiniDrawโ„ข 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 BetterWayโ„ข blood testing ecosystem, incorporating the BD MiniDrawโ„ข 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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