DoseOptics Receives 2nd FDA 510(k) Clearance for Multicamera High-Sensitivity BeamSite™ System

DoseOptics LLC announced today that it has received its second 510(k) clearance from the US Food and Drug Administration, for the advanced BeamSite™ system which combines multiple, high-sensitivity cameras with efficient data storage, to allow always-on capability in clinical radiation therapy use.
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.
The system is always on and uses multiple cameras to see all angles of the patient, which allows the system full patient coverage. “The radiotherapy team can see all aspects of the dose delivery to the patient’s skin, so that they have an intuitive understanding of what occurs inside the treatment room,” says Professor Brian Pogue, co-inventor of the technology and founder of DoseOptics. “Calculations and dosimetry go a long way, but in the end every delivery is managed by humans, and BeamSite provides those humans with the simple visual information needed to see what is going on.” Dr. Pogue is quick to add, “Published results from the Dartmouth-Hitchcock clinic showed clear areas for improved practice delivery, based upon a review of the images.”
DoseOptics received the initial clearance for BeamSite in December of 2020, and is manufacturing systems for early adopting clinics. 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 Ph.D. 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.”
About DoseOptics
The company was spun out of Dartmouth’s Thayer School of Engineering in conjunction with the Norris Cotton Cancer Center at Dartmouth-Hitchcock Health, in 2014. DoseOptics is intent on improving the delivery and quality of radiation therapy, through intuitive visual display of all treatments at the linac console and for subsequent review. Clinical systems have been successfully deployed at leading academic institutions across the world and resulted in over 50 peer reviewed publications. For more information, visit beamsite.com.
Source: DoseOptics LLC