RayStation treatment planning system receives FDA marketing clearance

RaySearch Laboratories AB (publ) has received FDA 510(k) clearance for its RayStation® treatment planning system.

RayStation® is RaySearch’s proprietary complete treatment planning system that integrates all RaySearch’s advanced treatment planning solutions into one flexible system. It includes functionality such as RaySearch’s market-leading algorithms for IMRT and VMAT optimization, highly accurate dose engines for both photon and proton therapy and will have full support for 4D adaptive radiation therapy. The system is built on the latest software architecture and has a graphical user interface offering state-of-the-art usability.

RaySearch’s business model is based on selling software modules through partnerships with leading medical technology companies. RaySearch’s modules are integrated into the partners’ systems and the partners have all contacts with the clinics. As a complement to this partner-based business model, RayStation® offers the possibility to collaborate directly with a few selected leading research-intensive clinics. This type of collaboration gives RaySearch the freedom to develop innovative solutions directly in a clinical environment, which is a prerequisite for securing the company’s long-term position as a leading supplier of advanced radiation therapy software.

In June 2009 a first agreement was signed in Europe with the German clinic WPE where RayStation® is planned to be clinically operational in 2010. Receiving 510(k) clearance means that RaySearch can now market RayStation® in the US and enter similar collaboration agreements in that region too.

”The fact that we now have our own treatment planning system with FDA clearance is a milestone of strategic importance,” says Johan Löf, CEO of RaySearch. ”We have no intentions to go out broadly to a large number of clinics so this does not mean that we alter our business model in a significant way. However, RayStation® gives us the possibility to develop the solutions of the future together with some of the world’s leading clinics, which is extremely important for us over the long term,” concludes Johan Löf.


RaySearch Laboratories


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