Photo courtesy of
Velano Vascular
The US Food and Drug Administration (FDA) has granted 510(k) clearance for a new iteration of a needle-free blood-draw device produced by Velano Vascular.
The device was originally cleared by the FDA last year.
It resembles a common syringe and allows peripheral intravenous catheters to be repurposed to draw blood from patients.
The goal of this is to reduce the need for additional needle sticks among patients receiving medications and hydration via intravenous delivery.
The new clearance for the blood-draw device covers a pair of modifications aimed at inpatient blood draws.
The first modification is a clamp for use with syringe draws. And the second is a revised indication for use that removes a limitation on when the device can be used with in-dwelling peripheral intravenous catheters.
“We rapidly implemented and pursued FDA clearance for these modifications based on input from patients and medical professionals who are using and systematically assessing our blood-draw technology,” said Eric Stone, co-founder & CEO of Velano Vascular.
Velano Vascular said it is working closely with clinical and non-profit partners, including Brigham and Women’s Hospital, Intermountain Healthcare, Griffin Health, The University of Pennsylvania Health System, The Children’s Hospital of Philadelphia, Children’s National Hospital, and Planetree, to capture patient and practitioner input regarding today’s approaches to inpatient blood draws and how the Velano technology could eventually become a standard of care.
