Velano Vascular wins FDA 510(k) for Pivo needle-free blood draw device

Velano Vascular said today it won FDA 510(k) clearance for its Pivo needle-free vascular access device designed for drawing blood.

The San Francisco, Calif.-based company said its Pivo is a single-use disposable device designed to take blood samples from indwelling peripheral IV lines to reduce the amount of needle sticks and central line acces for blood collection.

“Our experience with Pivo illuminates that blood draws can be a painless, lower risk experience for patients and practitioners. By further improving the usability and accessibility of this innovation, the potential exists for a global standard of more compassionate care,” Sutter Health chief nurse officer Anna Kiger said in a prepared statement.

Velano Vascular said its Pivo is currently in use at multiple health systems across the US with broader availability this year, dependent upon FDA clearance for its 2nd-gen Pivo solution.

“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,” CEO Eric Stone said in a press release.

Earlier this month, Velano Vascular said it raised another $3.5 million for its Pivo needle-free blood draw device. The company said it plans to use the proceeds from the round to further develop and commercialize the device.

Prior backers First Round Capital, White Owl Capital, Kapor Capital, Safeguard Scientifics, Griffin Hospital, The Children’s Hospital of Philadelphia and “a number of health industry veterans” joined the round, the company said. New investors included ex-Becton Dickinson (NYSE:BDX) chairman & CEO Ed Ludwig, “individual members of the Medline leadership team,” Oscar S. Schafer, Qosina founder Stuart Herskovitz and D-W Investments, Velano said.

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