News | December 01, 2011

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

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

Related Content

Cardiac MR, also called cardiac MRI or heart MRI, can offer data above and beyond anatomical imaging.

Cardiac MR can offer data above and beyond anatomical imaging, which is the main reason why this system was installed at Baylor Scott White Heart Hospital in Dallas. The system is a dedicated heart MRI scanner.

Feature | Magnetic Resonance Imaging (MRI) | February 19, 2020 | Dave Fornell, Editor
Videos | Magnetic Resonance Imaging (MRI) | December 20, 2019
James Carr, M.D., chair of the Department of Radiology, Northwestern University, and incoming 2020 President of the...
Greater Left Ventricular Mass Increases Risk of Heart Failure
News | Magnetic Resonance Imaging (MRI) | October 21, 2019
Elevated left ventricular mass, known as left-ventricular hypertrophy, is a stronger predictor of coronary artery...
Heart MRI example. An example of a cardiac MRI exam showing perfusion defects in the heart muscle, amount of infarct and edema and a score for myocardial salvage which can help determine if revasularization will help restore heart function.

A example of a cardiac MRI exam showing perfusion defects in the heart muscle, amount of infarct and edema and a score for myocardial salvage, which can help determine if revasularization will restore heart function following a heart attack.

News | Magnetic Resonance Imaging (MRI) | October 07, 2019
October 7, 2019 – A recent study published in the New England Journal of Medicine supports the use of
Machine Learning Could Offer Faster, More Precise Cardiac MRI Scan Results
News | Magnetic Resonance Imaging (MRI) | September 25, 2019
Cardiac magnetic resonance imaging (MRI) analysis can be performed significantly faster with similar precision to...
Haojie Wang, M.D., director of advanced cardiovascular MRI and a member of the heart valve clinic at Baylor Scott White Heart Hospital, Dallas. His hospital installed a dedicated cardiac Siemens 1.5T MRI scanner in 2018 because MRI offers soft tissue visualization not available on CT or ultrasound.

Haojie Wang, M.D., director of advanced cardiovascular MRI and a member of the heart valve clinic at Baylor Scott White Heart Hospital, Dallas. His hospital installed a dedicated cardiac Siemens 1.5T MRI scanner in 2018 because MRI offers soft tissue visualization not available on CT or ultrasound.

Feature | Magnetic Resonance Imaging (MRI) | September 06, 2019 | Jeff Zagoudis, Associate Editor
Traditionally, computed tomography (CT) and ultrasound have been the workhorse imaging modalities in the world of car
Displacement comparison at the end-systolic frame and final frame

Displacement comparison at the end-systolic frame and final frame. The three patients (V6, V10, V16) with different left-ventricle walls are shown. Point-to-surface distance is a measure to estimate the distance of a point from the reference surface. Image courtesy of WMG, University of Warwick

News | Magnetic Resonance Imaging (MRI) | August 28, 2019
A new 3-D magnetic resonance imaging (MRI) computing technique developed by scientists in WMG at the University of...
FDA Issues Draft Guidance on Medical Device Safety in MRI Environment
News | Magnetic Resonance Imaging (MRI) | August 01, 2019 | Jeff Zagoudis, Associate Editor
The U.S. Food and Drug Administration (FDA) issued a new draft guidance titled Testing and Labeling Medical Devices for...
360 Photos | Magnetic Resonance Imaging (MRI) | May 17, 2019
This is a dedicated cardiac Siemens 1.5T MRI system installed at the...