Technology | June 10, 2011

FDA Clears First Combined PET/MR System

Molecular MR system offers simultaneous whole-body acquisition of MRI and PET data

June 10, 2011 – The U.S. Food and Drug Administration (FDA) granted Siemens Healthcare 510(k) clearance for the Biograph mMR, the first system worldwide to enable simultaneous whole-body acquisition of data from magnetic resonance (MR) and positron emission tomography (PET).

While MR provides exquisite morphological and functional details in soft tissue, PET goes further to investigate the human body at the level of cellular activity and metabolism. The Biograph mMR enables users to generate the location, function and metabolic activity of organs in a single image at the same time.

The Biograph mMR allows a combined approach to imaging anatomical, functional and biochemical characteristics of disease. Potential clinical applications for molecular MR include the early identification and staging of malignancies, therapy planning and treatment. The Biograph mMR shows the greatest promise in oncologic and neurologic applications where MR and PET have proven their clinical value.

The Biograph mMR has been adopted as a diagnostic imaging research tool for developing novel approaches to the understanding, diagnosis, and treatment of disease. Initial Biograph mMR installations are at the University Hospital in Tuebingen and the University Hospital “Klinikum rechts der Isar” of the Munich Technical University, both in Germany; and Boston’s Massachusetts General Hospital.

"We’ve initiated clinical use testing of Biograph mMR in an effort to diagnose diseases at a very early stage; to see the progression of disease and to use that information to develop a therapy plan precisely focused on the respective patient. Furthermore, we plan to use the system for cancer followup in the long run, by reducing radiation exposure by the use of the system,” said Prof. Dr. Markus Schwaiger, director of the Clinic for Nuclear Medicine at the “Klinikum Rechts der Isar” of the Munich Technical University.

Prior to the Biograph mMR, the integration of MR and PET technologies was nearly impossible. The conventional PET detectors, which use photomultiplier tubes, could not be used in the strong magnetic field generated by an MR system. Integration was further limited by the lack of space inside the MR device. For this reason, previous MR-PET fusion imaging solutions relied not on simultaneous imaging, but rather sequential imaging (or post-scan registration) of MR and PET data, resulting in a significant time lag.

The Biograph mMR represents the first complete integration of diagnostic-grade MR and PET into a single-gantry whole-body scanner through incorporation of its 3.0T MR technology and unique Avalanche photodiode solid-state PET detector technology, which addresses the functional incompatibility of MR and PET. With the Biograph mMR, patients can be scanned in as few as 30 minutes for a combined whole-body exam, compared to one hour or more for sequential MR and PET exams. Additionally, Biograph mMR has a footprint comparable to a standard, high-field MR scanner and can be sited in a typical MR room, eliminating renovation costs for facilities seeking to replace an existing MRI.

Earlier this year, Siemens Healthcare received the 2011 North American Frost & Sullivan Award for New Product Innovation for the Biograph mMR. The Growth Partnership Company presented the award to Siemens for demonstrating excellence in the following categories: innovative element of the product, leverage of leading-edge technologies, value-added features/benefits, increased customer return on investment (ROI) and customer acquisition/penetration potential.

For more information: www.siemens.com/healthcare

Related Content

New ASNC SPECT Imaging Guideline Addresses Advances in Myocardial Perfusion Imaging
News | SPECT Imaging | June 21, 2018
The American Society of Nuclear Cardiology (ASNC) has published an update to its 2010 guidelines for single photon...
FDA Clears New Imaging Functionalities for Biograph mCT PET/CT Systems
Technology | PET-CT | June 21, 2018
Siemens Healthineers will announce U.S. Food and Drug Administration (FDA) clearance of four new system features for...
Technology | Focused Ultrasound Therapy | June 19, 2018
EDAP TMS SA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Focal One device for...
Elekta Unity High-Field MR-Linac Receives CE Mark
News | Image Guided Radiation Therapy (IGRT) | June 18, 2018
Elekta announced that its Elekta Unity magnetic resonance radiation therapy (MR/RT) system has received CE mark,...
Washington University in St. Louis Begins Clinical Treatments With ViewRay MRIdian Linac
News | Image Guided Radiation Therapy (IGRT) | June 14, 2018
June 14, 2018 — The Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in S
PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
Reduced hippocampal volume on MRI

This figure shows reduced hippocampal volume over the course of 6 years as seen on progressive volumetric analysis and also coronal MRI evaluations (arrows).Progressive volume loss in the mesial temporal lobe on MRI is a characteristic imaging feature of AD. This patient was a case of Alzheimer’s Dementia.

 

News | Neuro Imaging | June 12, 2018
According to a UCLA Medical Center study, a new technology shows the potential to help doctors better determine when...
High Prevalence of Atherosclerosis Found in Lower Risk Patients
News | Magnetic Resonance Imaging (MRI) | June 08, 2018
Whole-body magnetic resonance angiography (MRA) found a surprisingly high prevalence of atherosclerosis in people...
Philips Receives FDA 510(k) for Ingenia Elition MR System
Technology | Magnetic Resonance Imaging (MRI) | June 07, 2018
Philips announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its...
Nuclear imaging scan showing very good tissue delineation. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Nuclear imaging scan showing very good tissue delineation. It offers crisp overall image quality and sharply delineates the muscle and fat planes, vertebral margins and end plates, billiary radicals, renal calyces, aortic wall and papillary muscles of the heart. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Technology | PET-CT | June 05, 2018
June 5, 2018 — The U.S.
Overlay Init