Subject: FDA
RaySearch Receives FDA Clearance for RayStation 8B Including Machine Learning Functionalities
STOCKHOLM, July 11, 2019 /PRNewswire/ -- RaySearch has received 510(k) clearance from the FDA in the USA for version 8B of the treatment planning system RayStation®. RayStation 8B was released in December 2018 and includes the first machine learning applications in a treatment planning system on the radiation oncology market today.
The machine learning applications for automated treatment planning and automated organ segmentation in RayStation help improve efficiency and consistency in the clinic. The machine learning framework allows for models to be trained on the clinic's available data, and it is also possible to use pre-trained models provided by RaySearch.
The machine learning application for organ segmentation, using deep neural networks, was developed by RaySearch's in-house machine learning department and the machine learning planning was developed in collaboration with Princess Margaret Cancer Centre in Toronto, Canada.
The FDA clearance for the deep learning segmentation allows for automated generation of organs for all body sites while the clearance for machine learning planning application was provided at the model level, where a Prostate VMAT planning model from Princess Margaret Cancer Centre was approved.
Johan Löf, founder and CEO of RaySearch, says: "This clearance is a major step towards unleashing the unlimited potential of oncology software, led by RaySearch. More sophisticated automation means increased usability, efficiency and patient safety. This allows resources and clinicians to be focused on more challenging cases, education and such. Continuous development within oncology software is a key component in tomorrow's patient specific care plans."
About RaySearch
RaySearch is a medical technology company that develops innovative software solutions to improve cancer care. The company markets the RayStation treatment planning system and RayCare, the next-generation oncology information system, worldwide. Over 2,600 clinics in more than 65 countries use RaySearch's software to improve life and outcomes for patients. The company was founded in 2000 and the share has been listed on Nasdaq Stockholm since 2003.
About RayCare
RayCare is designed to support the complex logistical challenges of modern oncology clinics. It represents the future of oncology information system technology, supporting the vision of one oncology workflow. Many cancer patients receive a combination of treatment types, and RayCare is designed to reflect that. It will efficiently coordinate activities in radiation therapy, chemotherapy and surgery and will offer advanced features for clinical resource optimization, workflow automation and adaptive radiation therapy. RayCare is being developed with tomorrow's requirements for advanced analytics and decision support in mind.
About RayStation
RayStation is a flexible, innovative treatment planning system, chosen by many of the leading cancer centers worldwide. It combines unique features such as unmatched adaptive therapy capabilities, multi-criteria optimization, market-leading algorithms for IMRT and VMAT optimization with highly accurate dose engines for photon, electron, proton and carbon ion therapy. RayStation supports a wide range of treatment machines, providing one control center for all treatment planning needs and ensuring centers get greater value from existing equipment. RayStation also seamlessly integrates with RayCare, the next-generation oncology information system. By harmonizing the treatment planning, we enable better care for cancer patients worldwide.
More information about RaySearch is available at www.raysearchlabs.com
For further information, please contact:
Johan Löf, Founder and CEO, RaySearch Laboratories AB (publ)
Telephone: +46 (0)8-510 530 00
Peter Thysell, CFO, RaySearch Laboratories AB (publ)
Telephone: +46 (0)70 661 05 59
[email protected]
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SOURCE RaySearch Laboratories
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