Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its VitalBeam radiotherapy system.
The VitalBeam system is a modular, high-throughput radiotherapy system which incorporates technology from the company’s TrueBeam radiotherapy system, the Palo Alto, Calif.-based company said.
“The VitalBeam system will enable us to complete image-guided treatments quickly—in as little as 2-4 minutes when using advanced capabilities like RapidArc—and to shape the radiation dose very precisely. That will be good news for the cancer patients of our region,” Dr. T. P. Sahoo of Bhopal, India’s Chirayu Medical College and Hospital said in a press release.
The Chirayu Medical center was “among the 1st” to receive the new piece of equipment, Varian Medical said, though centers in the U.S. and Europe have put in orders for the next-generation unit.
“Our goal, with this platform, was to help increase access to quality cancer care around the world. We are gratified to work with institutions like the Chirayu Medical College in bringing advanced, image-guided radiotherapy to more cancer patients,” Varian oncology systems prez Kolleen Kennedy said in prepared remarks.
In July, Varian Medical released its fiscal Q3 earnings and announced it acquired Netherlands-based X-ray component manufacturer Claymount for $55 million (€50 million).
The company grew from Q3 last year but failed to meet the street on earnings and revenue. Varian reported $1.13 earnings per share for the quarter, an 11¢ increase since last year, but still 10¢ below analysts expectations.
The post Varian Medical wins FDA 510(k), CE Mark for VitalBeam appeared first on MassDevice.
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