Velano's PIVO blood draw device secures third FDA 510(k) clearance
Medical device company Velano Vascular's needle-free blood draw device PIVO has secured 510(k) clearance from the US Food and Drug Administration (FDA).
PIVO is a single-use, disposable device developed to provide consistent, quality blood samples from indwelling peripheral IV lines, in addition to minimising the repeated needle sticks and central line access for blood collection.
Designed for ease-of-use and high volume manufacturing, the new device aims at decreasing risk for both patients and practitioners.
Velano Vascular chief executive Eric Stone said: “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.
“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.”
Through the new device, the firm intends to enable hospitals to better serve patients with difficult venous access (DVA), along with offering a financially responsible alternative for health systems.
It is expected that the improvement of usability and accessibility of the PIVO may attain its potential for global standard of care.
Currently in use at multiple health systems in the US, Velano plans to expand the availability of the device this year after this clearance for the second generation PIVO solution.
The frim focuses on minimising the pain, risk and inefficiencies of vascular access and blood collection practices.