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Medical Devices / Submissions and Approvals

Radiation Dose Monitor Gains Expanded Clearance

April 1, 2019
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The FDA granted AngioDynamics expanded 510(k) clearance for its OARtrac Radiation Dose Monitoring System, a device used to measure photon radiation and high dose rate (HDR) brachytherapy during cancer treatments.

The additional clearance is for use with pre-calibrated, patient-specific peak skin dose sensors that measure photon and electron radiation therapy to supplement a patient’s treatment planning.

The OARtrac system enables clinicians to measure and validate radiation doses targeted at a specific area of the patient’s body, providing more information and accuracy for dosing.

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