FDA grants section 510(k) clearance to Calypso soft tissue Beacon transponder - Varian Medical
Varian Medical Systems announced that it has received 510(k) clearance from the FDA for a Calypso soft tissue Beacon transponder that can help enhance the precision of radiotherapy and radiosurgery treatments for cancer.
The size of a grain of rice, the new transponders can be implanted within soft tissue throughout the body, with the exception of the lung. The Calypso GPS for the Body system can then continuously track and monitor the position of the transponders, so that the high energy treatment beams can be precisely aimed to minimize exposure of surrounding healthy tissues. An earlier version of the Calypso Beacon transponder was cleared for use specifically in the prostate and prostatic bed; the new clearance makes the system applicable for many other types of cancer.