FDA 510(k) clearance for PIVO™ needle-free blood draw technology

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Medical device innovator Velano Vascular announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for PIVO™, its innovative needle-free vascular access device that seeks to improve the blood draw experience for patients while reducing risk to both patients and practitioners” VelanoVascular (2017).

VelanoVascular report “Medical device innovator Velano Vascular announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for PIVO™, its innovative needle-free vascular access device that seeks to improve the blood draw experience for patients while reducing risk to both patients and practitioners. Based on significant usage and input from practitioners, the new, improved device is designed for ease-of-use and high volume manufacturing.

“The deliberate and thoughtful design inputs for the next generation of PIVO reflect our commitment to rapid product development cycles informed by real world experience in the country’s leading health systems,” said Velano Vascular Chief Executive Eric M. Stone. “Feedback from hundreds of practitioners already using our technology reinforced PIVO’s ability to enhance the blood draw experience for patients and clinical staff, and helped us to develop a next generation product better suited for widespread adoption.”

PIVO is a single-use, disposable device that enables consistent, high quality blood samples from indwelling peripheral IV lines, allowing hospitals to reduce reliance on repeated needle sticks and central line access for blood collection. In addition to seeking a more compassionate care experience for patients, a safer environment for practitioners, and a more financially responsible alternative for health systems, PIVO aims to equip hospitals to better serve the increasing population of DVA (Difficult Venous Access) patients.”

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