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    FDA Approves Philips Whole Body PET / MR Imaging System said:
    November 28, 2011 at 11:05 pm

    Technological frontiers are being pushed back once again with Royal Philips Electronics announcing 501(k) FDA approval of its Whole Body PET / MR Imaging System. It is Philips’ first commercially available whole body positron emission tomography/magnetic resonance (PET/MR) imaging system, the Ingenuity TF PET/MR and the hardware is being displayed at the 97th annual meeting of the Radiological Society of North America (RSNA), November 27 – December 2.

    Until now, the idea of combining Positron Emission Tomography and Magnetic Resonance (PET/MR) imaging was thought to be an impossibility, but Philips has worked through tremendous technological challenges to produce a state of the art hybrid platform, that promises to expand the bounds of what is possible in the realm of full bodyimaging.

    The system is built to facilitate both standalone MRI scanning as well as hybrid PET / MR scanning, and the workflow has been built around the current hybrid technology which uses PET / CT scanning. The patient table rotates between each mode, allowing flexibility and eliminating the need for medical facilities to invest in multiple scanners. It makes the healthcare professional’s life easier, saves costs on multiple machines and cuts down on space needed to house the equipment.

    The Ingenuity TF PET/MR

    Zahi Fayad, professor of radiology and medicine (cardiology), and director, Translational and Molecular Imaging Institute, at the Mount Sinai School of Medicine, confirmed that tests on the Philips Ingenuity TF PET/MR have shown that combining high fidelity PET and MR imaging together gives high quality diagnostic images :

    “The PET/MR system will be useful to practitioners because of the highly anatomical and contrast images that can be acquired when you combine functional MR images with the metabolic information acquired by PET.”

    One of the main advantages that have already been demonstrated in clinical cases is that 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 superior soft-tissue contrast of 3T MR to image disease as it proliferates in soft tissue. As a testament to the system’s innovation, The Wall Street Journal selected the Ingenuity TF PET/MR as a 2011 runner-up in the medical device category for its annual Technology Innovation Awards.

    Gene Saragnese, executive vice-president and CEO, Imaging Systems, for Philips Healthcare said :

    “Over the years, the introduction of new medical imaging technologies has helped to expand clinical horizons … 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.”

    Mount Sinai and University Hospitals/Case Western Reserve University in Cleveland, will install and run the first Philips combined, whole body PET/MR systems in the U.S. Professor Fayad said :

    “We are specifically interested in PET/MR because the combination is expected to provide a more advanced understanding of the processes taking place in vascular beds.”

    With the program formally launched in 2007, Philips’ PET/MR system is one of the results of the company’s continuous investments in health care R&D even in adverse economic times. PET/MR is the embodiment of hybrid imaging, a major trend that is a growth driver of imaging procedure volumes. Philips was the first company to bring a PET/MR system to market when CE Mark in Europe was earned in January 2011. With FDA clearance, the system can now be marketed in the world’s largest health care market.

    So far, 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.

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