FDA Clears RaySearch Laboratories' RayStation® 3.5
Published: May 15, 2013
RaySearch Laboratories: RaySearch Receives 510(k) Clearance for RayStation® 3.5
STOCKHOLM--(BUSINESS WIRE)-- Regulatory News: In March RaySearch Laboratories AB announced that version 3.5 of RaySearch's RayStation® treatment planning system had been released for clinical use. RaySearch has now received 510(k) clearance from the FDA for RayStation® 3.5 meaning that the new features can be marketed in the US.
The most important new features are state of-the-art tools for treatment planning of radiation therapy with electrons and protons, complementing RayStation’s extensive tools for planning and optimization of radiation therapy with photons. Proton Beam Design is a brand new module in RayStation® that contains tools for treatment planning of double scattered and uniformly scanned protons, such as a clinically approved Pencil Beam dose engine and automatic generation of treat-and-protect beams. This is the first clinical release of proton planning functionality in RayStation®, to be followed by many others, such as Pencil Beam Scanning techniques and Monte Carlo dose calculations. Electron Beam Design is another entirely new module that includes a Monte Carlo dose engine for electron radiation therapy and tools for manual editing of beams similar to how it is done in the 3D-CRT module.
In addition the new version contains a wide range of other new features and improvements.
“We are of course happy that we now have a complete offering for our US customers, with support for all treatment modalities including protons and electrons, and support all IMRT and VMAT delivery modes with all relevant treatment machines. This new version also includes some highly useful tools to improve the clinical workflow and further expands our market-leading toolbox for adaptive 4D treatments, which I believe further cements RayStation’s position as the most advanced treatment planning system on the US market”, says Johan Löf, CEO of RaySearch.
About RayStation® RayStation® integrates all RaySearch’s advanced treatment planning solutions into a flexible treatment planning system. It combines unique features such as multi-criteria optimization tools with full support for 4D adaptive radiation therapy. It also includes functionality such as RaySearch’s market-leading algorithms for IMRT and VMAT optimization and highly accurate dose engines for photon, electron and proton therapy. The system is built on the latest software architecture and has a graphical user interface offering state-of-the-art usability.
RaySearch Laboratories is a medical technology company that develops advanced software solutions for improved radiation therapy of cancer. RaySearch’s products are mainly sold through license agreements with leading partners such as Philips, Nucletron, IBA Dosimetry, Varian and Accuray. To date, 15 products have been launched through partners and RaySearch’s software is used at over 2,000 clinics in more than 30 countries. In addition, RaySearch offers the proprietary treatment planning system RayStation® directly to clinics. RaySearch was founded in 2000 as a spin-off from Karolinska Institutet in Stockholm and the company is listed in the Small Cap segment on NASDAQ OMX Stockholm.
For more information about RaySearch, visit www.raysearchlabs.com
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Johan Löf, President and CEO, RaySearch Laboratories AB
Telephone: +46 (0)8-545 061 30
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