GE Healthcare seeks FDA clearance for SIGNA PET/MR device

5 August 2014 (Last Updated August 5th, 2014 18:30)

UK-based GE Healthcare is seeking US Food and Drug Administration (FDA) 510(k) clearance for its first integrated, simultaneous, time-of-flight (TOF) capable, whole body SIGNA PET/MR device.

SIGNA PET/MR

UK-based GE Healthcare is seeking US Food and Drug Administration (FDA) 510(k) clearance for its first integrated, simultaneous, time-of-flight (TOF) capable, whole body SIGNA PET/MR device.

Powered by company's latest 3.0 Tesla magnetic resonance (MR) technology and PET technology for simultaneous image acquisition, the device will help clinicians achieve improved scan efficiency for treatment of oncology, neurology and cardiology.

The SIGNA PET/MR incorporates the company's MR-compatible silicon photomultiplier detector (SiPM) technology with a fast coincidence timing resolution that enables time-of-flight (TOF) reconstruction, leading to improved positron emission tomography (PET) image quality with higher structural detail and an improved signal-to-noise ratio.

The company said that with TOF reconstruction, arrival times of each coincident pair of photons are more precisely detected, and the time difference between them is used to localise the PET signal accurately.

Stanford University Medical Center associate professor of radiology Andrei Iagaru said: "We are excited about SIGNA PET/MR because of its clinical and research potential.

"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 paediatrics 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.

"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 paediatrics in the future."

"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."

Compared with conventional PET technology, the new SiPM technology is up to three times more sensitive.

The company has designed the SIGNA PET/MR to be fully upgradable from a Discovery MR750w 3.0T.

GE Healthcare president and CEO Richard Hausmann said: "We have received extremely positive feedback from our installations of the research PET/MR systems.

"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."


Image: GE Healthcare's SIGNA PET/MR device. Photo: courtesy of General Electric.