Phillips gets FDA approval for its combo PET/MRI scanner

By Dr. Ananya Mandal, MDNov 29 2011

Royal Philips Electronics NV has received approval from U.S. regulators to introduce a single medical imaging device that can scan the body for cancer using two technologies.

The machines use PET, or positron emission tomography, to identify cancer cells as they absorb chemical tracers. At the same time, they use MRI or magnetic resonance imaging to view surrounding tissue. “The comparison would be that the PET scan is like a GPS system and the MRI provides the map,” Philips spokesman Steve Klink said Monday. The scanner uses a chemical tracer to image organs and tissues, while magnetic fields and radiowaves also scan bone, and combining systems helps improve the diagnosis of cancers and cardiovascular diseases at lower radiation levels than x-rays, he explained.

Permission to sell the PET/MR scanner from the Food and Drug Administration culminates a multi-million-euro development phase spanning seven years, said Rusckowski. The Dutch company has 13 orders for the machine outside the U.S.

“The jury is still out” on whether the system can replace traditional scanners, Rusckowski said in the interview. GE leads the U.S. health-care scanner market, followed by Siemens AG of Germany. The U.S. Food and Drug Administration approved a similar device made by German rival Siemens AG for the first time in June 2011.

Philips, based in Amsterdam, is hoping U.S. hospitals will opt for the benefits of having a combined scanner that can accelerate imaging time for patients, Rusckowski said.

For Chief Executive Officer Frans van Houten, it's an opportunity to expand in a growth market as he steers Philips away from struggling consumer electronics and lighting. “This should give them some incremental sales in the U.S. and help the growth outlook in the business,” said Martin Prozesky, an analyst at Sanford C Bernstein Ltd. The U.S. is still the most important imaging equipment market, he said.

Philips developed the PET/MR scanner at its nuclear medicine headquarters in Cleveland, and more orders are in the pipeline, Rusckowski said. “There is a lot of pressure on the health care systems, but despite the pressure there is still interest in investing in the future,” Rusckowski said.