Philips Receives FDA Clearance to Market its PET/MR Imaging System in the U.S.

 

December 1, 2011

November 28, 2011 – Philips Healthcare announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s first commercially available whole body positron emission tomography/magnetic resonance (PET/MR) imaging system, the Ingenuity TF PET/MR. This platform will redefine how medicine is practiced in the future by helping clinicians and researchers investigate novel personalized medicine and treatments for oncology, cardiology and neurology. 

It was previously thought that PET and MR scans were incompatible; however, Philips overcame the technical hurdles, through advances in technology, to create a new class of hybrid imaging that will push the bounds of what’s possible in imaging. The system is designed to provide a state-of-the-art platform well into the future by facilitating the addition of new technologies as they become available.  

Studies on the Ingenuity TF PET/MR have shown that bringing high-fidelity PET and MR imaging together provides high-quality diagnostic images. Clinical cases have already shown the advantages of being able to superimpose PET over MR images to help detect abnormalities in various organs. Previously, this was not possible because the two studies took place at different times, with different conditions and with different patient positions. In addition to the possibility of expanding clinical horizons as an advanced research tool, the system could also be used in a clinical setting to support a patient’s entire care cycle process from detection or diagnosis to long-term disease management.   

The system features Philips’ proprietary Time-of-Flight (TOF) technology, Astonish TF, a technology for PET scanners that is designed to enhance image quality by reducing noise and providing increased sensitivity. It is combined with the soft-tissue contrast of 3.0T MR to image disease as it proliferates in soft tissue.

Mount Sinai and University Hospitals, Cleveland, will house the first Philips combined, whole body PET/MR systems in the U.S. To date, Philips has sold 13 systems worldwide, and already installed systems at Mount Sinai School of Medicine in the U.S.; the University of Geneva in Switzerland; Helmholtz-Zentrum Dresden-Rossendorf (HZDR) in Dresden, Germany; Centro Nacional de Investigaciones Cardiovasculares (CNIC) in Madrid, Spain; and Pusan National University in Korea. The system will be installed December 2011 at University Hospitals /Case Western Reserve University in Cleveland.  

For more information: www.philips.com/RSNA