GE Healthcare’s New SIGNA™ PET/MR Pending 510(k) Approval
Waukesha, WI — August 4, 2014 — Today GE Healthcare announced that the first integrated, simultaneous, time-of-flight (TOF) capable, whole body SIGNA PET/MR* is 510(k) pending at the FDA. Powered by simultaneous image acquisition from GE’s latest 3.0 Tesla magnetic resonance (MR) technology and innovative positron emission tomography (PET) technology, the SIGNA PET/MR represents a new chapter in helping clinicians achieve improved scan efficiency that may lead to more effective treatment paths for clinicians to offer their patients, particularly for oncology, neurology, and cardiology.
MR is excellent for imaging soft tissue as well as functional and morphological details. PET enables clinicians to visualize cellular activity and metabolism. When these two powerful tools are combined, clinicians may be able to see early cellular changes that can be accurately mapped onto MR images. With this knowledge, clinicians may be able to shorten the time between diagnosis and treatment, in addition to offering the convenience of simultaneous PET and MR scans for patients. Research systems are installed at Stanford University, University of California San Francisco, and University of Zurich.
“We are excited about SIGNA PET/MR because of its clinical and research potential,” said Dr. Andrei H. Iagaru, associate professor of Radiology and Co-Chief of the Division of Nuclear Medicine and Molecular Imaging at Stanford University Medical Center. “We have been using the system for research and we are able to explore novel things in areas like neurology and oncology, as well as in pediatrics in the future. Additionally, it’s more convenient for the patient due to simultaneous scanning. We can also initiate innovative, complex research; simultaneity allows us to do functional neuro imaging, cardiac imaging, and musculoskeletal imaging that we haven’t been able to do before. Time-of-flight offers improved image quality in PET/MR and with the increased detector sensitivity, it may lead to future improvements in dose reduction.”
The SIGNA PET/MR features GE’s new, exclusive MR-compatible silicon photomultiplier detector (SiPM) technology. This new digital detector is characterized by its enhanced sensitivity; it is up to three times more sensitive than conventional PET technology. It also features fast coincidence timing resolution enabling TOF reconstruction. With TOF reconstruction, the arrival times of each coincident pair of photons are more precisely detected, and the time difference between them is used to localize the PET signal accurately. TOF leads to improved PET image quality with higher structural detail and improved signal-to-noise ratio. The SIGNA PET/MR is designed to be fully upgradable from a Discovery MR750w 3.0T.
“We have received extremely positive feedback from our installations of the research PET/MR systems,” said Richard Hausmann, president and CEO of GE Healthcare MR. “Our research partners are very excited by the performance of the system and the potential of this new technology. We are proud to bring the first TOF-capable, simultaneous PET/MR system, pending FDA clearance, to market.”
SIGNA is a trademark of the General Electric Company.
*SIGNA PET/MR is 510(k) pending at FDA. Not available for sale in the United States. Not yet CE Marked. Not available for sale in all regions.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
In September 2011, GE Healthcare announced it would dedicate $1 billion of its total R&D budget over the next five years to expand its advanced cancer diagnostic and molecular imaging capabilities, as well as its world-class technologies for the manufacture of biopharmaceuticals and for cancer research. Additionally, between 2010 and 2020, GE Healthcare plans to invest over $500 million in research into neurological disorders. The investment crosses all lines of GE Healthcare's global business and focuses on developing new neurology diagnostic solutions, educating consumers, and expanding research already in progress. In 2013, a $60 million investment with National Football League to develop new MR technology for traumatic brain injury was announced, including a $20 million Global Challenge to advance diagnosis and prognosis of mild TBI.