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Varian gets FDA 510(k) clearance for Calypso anchored beacon transponder for lungs

Published 23 April 2018

Varian has secured 510(k) clearance from the US Food and Drug Adminsitration (FDA) clearance for its Calypso Anchored Beacon transponder.

Used with a Varian TrueBeam, Edge and Clinac C-series medical linear accelerators, the Calypso system and Anchored Beacon transponder detects even slight movements of a tumor and helps clinicians deliver lung stereotactic body radiotherapy (SBRT) more precisely.

The Calypso system works by implanting the Anchored Beacon transponders in small airways within or near the tumor target.

The Anchored Beacon transponders feature five small "legs" that provide stable fixation to prevent the transponder from moving. T

he transponders emit non-ionizing electromagnetic signals that are tracked in real-time and used to keep a treatment beam on target.

The Calypso System is the only device on the market that delivers real-time, continuous (25 Hz update rate), 3D tumor position information, improving confidence that the prescribed dose has been delivered to the tumor.

Varian global portfolio solutions vice president Ed Vertatschitsch said: "The 510(k) clearance of the Anchored Beacon transponder expands the application of the Calypso system platform.

"Using the Calypso system and Anchored Beacon transponder, clinicians can deliver dose to lung tumors with increased confidence and accuracy."

Varian is a leader in developing and delivering cancer care solutions, and is focused on creating a world without fear of cancer. Headquartered in Palo Alto, California, Varian employs approximately 6,500 people around the world.

Source: Company Press Release