FDA clears new Varian Calypso transponder

Radiation oncology firm Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a transponder designed for use with its real-time tracking technology.

The Calypso soft-tissue Beacon transponder is the size of a grain of rice and can be implanted within soft tissue throughout the body, except for the lung, according to Varian. It emits a nonionizing electromagnetic signal that is tracked in real-time by the Calypso GPS for the Body system. This allows the guidance of treatment beams to precisely target tumors during radiotherapy and radiosurgery with medical linear accelerators, such as Varian's Edge radiosurgery system, the firm said.

A previous incarnation of the Calypso Beacon transponder was cleared for use in the prostate and prostatic bed; the new transponder is now also cleared for other types of cancer.

The new transponder can only be used with the latest upgrade of the Varian Calypso system (version 3.0). Current Calypso Beacon transponders for the prostate are not appropriate for the new soft-tissue indication due to device and labeling differences, Varian said.

Initial use is expected toward the end of the year, with a full commercial rollout sometime next year. The transponder is cleared for the U.S. market only.

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