FDA Clears RadiaDyne 510(k) for Radiation Dose Monitor

FDA has cleared a RadiaDyne 510(k) for two new indications for its OARtrac radiation dose monitoring platform.  With the added indications, RadiaDyne says physicians can now use the device to routinely monitor brachytherapy radiation dose in certain anatomies, as well as reuse the proprietary OARtrac PSD (Plastic Scintillating Detector) sensor cable up to five times on the same patient.

OARtrac is described by the company as a patient monitoring technology which monitors the delivery of clinical radiation dose for cancer treatment in real-time. It can provide diagnostic pinpoint accuracy measurement of the radiation treatment plan by verifying the dose delivered is consistent with the prescribed dose. “Furthermore, based on reviewing the accumulative dose data provided by the system, radiation oncologists can adjust subsequent treatment if required allowing for a true adaptive radiation therapy protocol,” RadiaDyne says.