May 8, 2012
DOSIsoft receives FDA-510(k) clearance for EPIgray software
CACHAN, 24 April 2012 – DOSIsoft has received FDA-510(k) clearance for its new software EPIgray, a unique, innovative and independent solution for in vivo control of the delivered dose and error detection based on transit dosimetry using the a-Si EPID (Amorphous silicon Electronic Portal Imaging Device).
EPIgray, is a solution based on a formalism developed and validated by Curie Institute, a French leading center for radiotherapy, and is enriched by contributions and collaborations from the CEA LIST (Atomic Energy Commission, Saclay), the French institute for advanced R&D activities and from many other clinical centers.
The software conception perfectly fits the requirement for operating a quality control program in radiotherapy. EPIgray is the unique solution which meets the regulations relative to the radiotherapy safety; in vivo measurements becoming possible whatever the types of beams, from conventional treatment techniques to advanced ones such as IMRT (Intensity Modulated Radiation Therapy) or arc therapy (RapidArc and VMAT).
An innovative and promising challenge
In radiotherapy, medical imaging is a considerable asset for all stages of the disease management: from diagnosis, treatment planning and validation of all fractions (daily control and treatment adaptation) to post-therapeutic aspects (patient’s follow-up).
With EPIgray, portal imaging is not only a way to control the patient positionning but it is becoming the solution which allows, in nearly real-time, the comparison between actual dose and planned dose.
EPIgray is fully integrated into any technical platform workflow of the radiotherapy department. Automatically and without human intervention, the obtained transit image allows dose calculation at points of interest located in the tumor volume or in organs at risk. An information concerning dose deviations is displayed, automatic emails are sent if results are off-tolerance and the user can access the dashboard from any device connected to the intranet.
The observed deviations could result from an error on patient positioning, a modification in the medium traversed (due to tumor reduction, weight loss, breath, internal movements, gas…), an instability of the accelerator (beam, multi-leaf collimator), an error in implementation of accessories (wedge filters, positionning accesoiries, ...) or even a use of parameters corrupted during data transfer.
Finally, more than automatic control of delivered dose and beam control, EPIgray offers traceability features with Patient’s follow-up, allowing analysis and follow-up of anatomic patient’s changes during the treatment. EPIgray ensures that the treament is correct and if not, alerts the medical team that a therapeutic adaptation is necessary.
DOSIsoft, French leader on the Treatment Planning Systems (TPS) market, has been created as a spin-off from Gustave Roussy Institute, a leading European Cancer Treatment Center, and the Curie Institute. Today, Dosisoft is a high-tech company, specialized in development of comprehensive and innovative solutions, including planning systems that answer the new radiotherapy techniques, as well as specific Quality Assurance solutions to control the treatment. Moreover, DOSIsoft offers innovative solutions in Nuclear Medicine that supports diagnosis, for example through quantification and patient’s follow-up.
Visit our site- www.dosisoft.com