Medical technology firm Velano Vascular has received approval from the US Food and Drug Administration (FDA) for a modified version of its novel and needle-free blood draw device.
Velano device has been developed to reduce blood draw-related discomfort and anxiety for hospital inpatients.
The second FDA clearance of the firm’s patented technology comprised of two modifications designed to increase the product’s usability for inpatient blood draws.
The firm has added clamp for use with syringe draws and refinement to the indication for use (IFU).
Velano device is attached to a peripheral IV catheter to draw blood directly into a vacuum tube or a syringe, while the revised IFU removes a limitation in the earlier clearance that specified when the device could be used with in-dwelling peripheral IV catheters.
Velano Vascular co-founder and CEO Eric Stone said: "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.
"These enhancements reflect our customer-centric approach to introducing our technology into medical practice, both in terms of product enhancements and clinical use patterns."
In February 2015, the firm first received FDA approval for its blood-draw technology, which will reduce the need for needle sticks (clinically called venipunctures) for blood draws in the hospital.