Siemens Healthcare said Wednesday it received CE marking for its whole-body PET-MR hybrid system, meaning the device can now be marketed for clinical applications in European Union countries.

The Biograph mMR is the first integrated PET-MR device capable of doing simultaneous whole-body magnetic resonance imaging and positron emission tomography scans, Siemens said. It combines a 3-Tesla MR system with PET detectors, giving doctors the morphological and soft tissue information from MR with the cellular and metabolic activity data from PET.

Studies still need to be performed with the new technology, but some doctors hope it will have new applications in diagnosing cancer, heart disease and neurological disorders. Also, MRI could be an ionizing-radiation-free alternative to CT in providing attenuation correction for the PET image.
Currently, the device has been installed for research purposes at Massachusetts General Hospital in Boston, and at two German university hospitals.

A PET-MR scanner made by rival electronics giant Philips Healthcare received EU marketing approval earlier in the year. The Ingenuity TF PET-MR scanner features a rotating turntable, letting patients connect with separate MRI and PET scanners.

Siemens' product made its North American debut at the Radiological Society of North America's annual meeting in November, but Siemens first demonstrated the product four years ago.

The Biograph mMR is still pending 510(k) clearance by the Food and Drug Administration and is not commercially available in all countries, Siemens said.

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