Velano Vascular said today that it won 510(k) clearance from the FDA for a new iteration of its needle-free blood draw device.
San Francisco-based Velano, which raised a $5 million Series A round in February 2015, won its 1st FDA nod for the device last year.
The new clearance covers a pair of modifications to the device aimed at in-patient blood draws: A clamp for use with syringe draws and a revised indication for use that removes a limitation on when the device can be used with in-dwelling peripheral IV catheters, Velano 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,” co-founder & CEO Eric Stone said in prepared remarks. “These enhancements reflect our customer-centric approach to introducing our technology into medical practice, both in terms of product enhancements and clinical use patterns.”