AngioDynamics receives expanded FDA clearance for electron radiation therapy

AngioDynamics announced that the FDA granted an expanded 510(k) clearance for the OARtrac Radiation Dose Monitoring System. The additional indications clear the OARtrac System for use with patient-specific, pre-calibrated peak skin dose sensors used during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning. The OARtrac System allows clinicians to measure and validate radiation doses targeted to a specific area of a patient’s body, allowing for more accurate and informed dosing. The OARtrac System was previously cleared for use in the real-time monitoring and measurement of photon radiation and high dose rate brachytherapy during cancer treatments on both the skin surface and with endorectal balloon applications. The expanded Indication for Use now provides radiation oncologists and medical physicists with a tool to monitor and measure radiation doses in patients who receive electron radiation therapy, one of the most common radiotherapy treatments.

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