DoseOptics Receives FDA 510(k) Clearance for BeamSite™
Press Release (ePRNews.com) - HANOVER, N.H. - Jan 15, 2021 - DoseOptics LLC announced today that it has received 510(k) clearance for BeamSite™ by the US Food and Drug Administration.
Radiation therapy is a powerful tool used by oncologists to provide curative treatments to over a million patients per year in the US, and where one out of every four US citizens will receive it in their lifetime. Trends in radiotherapy treatment are calling for higher doses with fewer treatments, requiring higher demand for superior accuracy and precision in the treatment delivery. However, for the past 50 years, clinical teams have been working blind – relying on indirect methods to assure the accuracy of treatments which are difficult to use, time consuming and often imprecise. As a consequence, radiation delivery is actively verified in only about 20% of treatments. BeamSite is the world’s first video system that can directly image radiation therapy as it is delivered to the patient, providing a simple and intuitive means for the clinical team to monitor treatment as it happens, in every treatment, for every patient.
“Radiation therapists are on the front lines when radiation is administered and are best poised to catch any issues that might happen,” says Brian Pogue, co-inventor of the technology and founder of DoseOptics. “BeamSite gives them the ability to see the treatment beam on the patient in real time. Beyond that, the treatment video is recorded and can be reviewed by the physics or oncology staff anytime.”
Dr. Pogue is quick to add, “We expect it to be an important tool for any radiotherapy center’s quality improvement program.”
DoseOptics has begun manufacturing operations locally and is available to take orders. Systems have been installed for daily monitoring of treatment throughout the Dartmouth-Hitchcock Health network of providers.
The latest pilot study was published by radiation oncologist Dr. Lesley A. Jarvis MD PhD and colleagues in the Red Journal of Radiation Oncology (https://doi.org/10.1016/j.ijrobp.2020.11.013), where they showed significant clinical efficacy. Nearly 10% of patients treated had observations that could be improved for higher quality radiotherapy delivery. They reported, “In this limited cohort, we found opportunities to improve treatment delivery for individual patients… Of specific clinical importance, we show that Cherenkov imaging can detect stray radiation dose to tissues. Currently, there is no practical technique available to monitor contralateral breast dose or dose to other adjacent anatomy on a daily basis.”
DoseOptics’ mission is to improve the safety and accuracy of radiation therapy. It was founded in 2014 based on patented technology developed at Dartmouth’s Thayer School of Engineering in conjunction with the Norris Cotton Cancer Center at Dartmouth Hitchcock Medical Center. Research systems have been successfully deployed at leading academic institutions across the world and resulted in over 50 peer reviewed publications based on the technology. For more information, visit beamsite.com.
Contact: W. Ware, email@example.comSource : DoseOptics