FDA Clears Calypso® Medical’s GPS for the Body® for Prostatectomy Patients

SEATTLE--(BUSINESS WIRE)--Calypso® Medical announced today that the U.S. Food and Drug Administration (FDA) cleared a new indication for the use of implantable Beacon® electromagnetic transponders with the Calypso System in external beam radiation therapy. Known as GPS for the Body®, the Calypso System utilizes transponders to setup and continuously track the position of targeted tissue during radiation treatment. In the event that the tumor site moves outside of acceptable limits, the clinician adapts therapy during daily treatment to ensure the treatment is delivered as prescribed to the cancerous tissue while avoiding adjacent healthy organs. This is the only technology platform designed to provide objective, accurate and continuous tracking information during external beam radiation therapy without adding ionizing radiation. Radiation therapy is the standard of care for patients with a high risk of prostate cancer recurrence or those in whom recurrence has been diagnosed. Previously, GPS for the Body® technology was cleared solely for use in patients with an intact prostate. Studies indicate up to 20% of prostatectomy patients are diagnosed with recurrent prostate cancer following surgery and require adjuvant radiation therapy.

source: Calypso Medical