FDA clears Philips combination PET/MR scanner | Regulatory Roundup


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.

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.

The FDA nod pits Philips against med-tech titans General Electric (NYSE:GE) and Siemens Healthcare (NYSE:SI) for a piece of the U.S. health care scanner market. Siemens paved the way for the Ingenuity system in June when it won FDA clearance for its rival Biograph scanner, the first PET/MR combination scanner to clear the FDA’s Center for Devices & Radiological Health.

Philips shares rose 6 percent on news of the approval to open at $18.66 today from a $17.59 close Friday.

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