FDA clears Philips combination PET/MR scanner | Regulatory Roundup

November 28, 2011 by MassDevice staff

Philips wins FDA clearance to market its Ingenuity whole-body PET/MR imaging system in the U.S.

Philips Ingenuity Scanner

Philips Healthcare (NYSE:PHG) landed 510(k) clearance from the FDA to market its Ingenuity whole-body PET/MR imaging system in the U.S.

The scanner performs both PET and magnetic resonance imaging scans, allowing doctors to acquire images at a significantly lower radiation dose than traditional PET/computer tomography scanners, which use x-rays to make images.

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PET scans allow physicians to see how organs are functioning by injecting radioactive tracers into patients' blood streams; MRIs use magnetic fields and radiowaves to create detailed images of organs, soft tissues, bones and other body structures.

"The Ingenuity TF PET/MR is a state-of-the-art platform that will remain state-of-the-art as it continues to evolve over time to provide robust research and clinical value. This will change the way health care is practiced in the future," Gene Saragnese, CEO of Philips Healthcare Imaging Systems, said in prepared remarks.

Permission to sell the PET/MR scanner from the federal watchdog agency culminates a seven-year, multi-million-dollar development phase, Philips Healthcare CEO Steve Rusckowski told Bloomberg.