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Medical Devices / Submissions and Approvals

Hansen Medical Announces FDA OK, Launch of Magellan Transport System

Aug. 28, 2014

Intravascular robotics manufacturer Hansen Medical has launched its Magellan Transport System, following receipt of FDA 510(k) clearance. The rail is designed to move the company’s Magellan robotic arm between procedure rooms.

The transport system — which will be available in the third quarter — allows the robotic arm to be a shared resource among different procedure rooms equipped to support the system, the Mountain View, Calif. devicemaker said Wednesday. Hansen’s own clinical support personnel will operate the device during the initial commercialization period.

The robotic arm is used to navigate the peripheral vasculature and assist in manual placement of therapeutic devices. Hansen now plans to seek CE mark approval to market the transport system in Europe. — Kellen Owings

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