AngioDynamics (NSDQ:ANGO) said late yesterday that it won expanded FDA 510(k) clearance for its OARtrac radiation dose monitoring system.
With the new clearance, the Latham, N.Y.-based company’s OARtrac system is cleared for use with patient-specific, pre-calibrated Plastic Scintillating Detector sensors used during cancer treatments to monitor photon and electron radiation therapy as an adjunct to treatment planning.
AngioDynamics’ OARtrac system is designed to enable the measurement and validation of targeted radiation doses to improve accuracy and allow for more informed dosing.
“This expanded clearance provides us the opportunity to address an unmet need for patients in three of the most common types of radiation therapy, allowing for significantly improved outcomes. OARtrac is the type of disruptive technology that our customers value, and our team will continue to focus on creating additional pathways to help clinicians deliver the best possible treatment for their patients,” oncology senior VP Brent Boucher said in a press release.
The new indication adds to previous clearance which cleared the device for use in the real-time monitoring and measurement of photon radiation and high dose rate brachytherapy during cancer treatments on the skin surface and with endorectal balloon applications, AngioDynamics said. The system is also cleared for use with photon and electron energy.
In January, AngioDynamics saw shares rise after the medical device maker topped expectations on Wall Street with its second quarter financial results.
