NEWS: FDA Grants Adaptivo™ 510(k) Clearance
(Madison, WI), February, 15th 2016 – Standard Imaging, Inc., a global leader in radiation quality assurance for cancer treatment, announced today it received FDA 510(k) clearance for Adaptivo™ - a pioneering new technology expected to usher in the next generation of patient dosimetry.
“The success of Adaptivo will be measured in lives saved,” noted President & CEO Ed Neumueller. “We are now able to see how much dose is actually delivered to a patient’s tumor during the course of radiation therapy treatment. This is going to have a profound effect on patient treatment quality and patient safety. We’re very pleased the FDA has given us clearance to start offering this amazing product.”
Utilizing the treatment machine’s portal imager and cone beam CT capabilities, Adaptivo will empower oncologists to make informed decisions whether to adapt treatment plans based on the dose a patient has accumulated during treatment. There is currently no industry solution that can track how much cumulative dose a patient receives, including accounting for changes in daily patient setup, tumor volume, or weight loss.
“In recent years the idea of using our portal imagers for patient dosimetry has gained more traction in the medical physics community,” noted Shannon Holmes, Ph.D. Medical Physicist at Standard Imaging. “With Adaptivo we can make use of the portal imager to capture exit images during treatment, and we can also monitor the accumulated dose to critical organs throughout the entire course of treatment. It’s nothing short of game changing.”
Previous methods of patient dosimetry primarily involved using physical detector arrays or log-file based software that couldn’t account for changes in patient anatomy or setup. Adaptivo is expected to raise the bar significantly for patient treatment quality, which ultimately impacts both patient safety and patient outcomes.
Standard Imaging is a leading manufacturer of radiation calibration and quality assurance instruments for healthcare. The company was founded in 1989, and has become a leader in the medical physics field. Standard Imaging is committed to the fight against cancer by offering a suite of products aimed at supporting radiation therapy for cancer treatment.