PET/MRI System Receives CE Marking; 510 (k) Pending Approval

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Opening the door for commercial availability in Europe, The European Union (EU) has granted CE marking to Philips Healthcare’s Ingenuity TF whole body PET/MR system. Billed as the first commercially available unit of its kind, the system—which combines the molecular imaging capabilities of PET with the soft tissue contrast of MR to image the disease process on a cellular level in soft tissue—may now be sold commercially anywhere in the EU providing that translation requirements are met. Philips has also submitted a 510 (k) to the Food and Drug Administration requesting clearance to market the unit in the same fashion in the U.S.: A decision is pending. Proponents of PET/MR hold that a combination of the two modalities can provide new information in several areas. For instance, clinical investigators are already using the Ingenuity TF with cardiology and oncology patients. “Cardiologists are currently limited in how blood vessels are imaged, and we hope PET/MR scans can help provide more details on plaques and blockages,” said Satrajit Misra, Philips Healthcare’s senior director and head of global product marketing nuclear medicine (PET CT, SPECT CT and workstations). He added that the Ingenuity TF also has the potential to effectively image the prostate, pancreas and other organs in which cancers are often difficult to diagnose at an early stage. On the hospital side, Misra noted that with PET/MR in place, hospitals stand to improve departmental efficiencies and reap overall productivity gains. “This new modality enables researchers and clinicians to see the function and metabolism of tissue more precisely than ever before, which we hope will lead to more accurate diagnoses, improved chronic disease management, and personalized treatments,” he explained. Moreover, clinical validation studies of the Ingenuity TF PET/MR have demonstrated the value of bringing PET and MR together; allowing patients to remain on the same table for the duration of an examination decreases throughput time and increases patient comfort while helping to streamline hospital workflow as compared to conventional MR and PET/CT examinations. Misra says the Ingenuity TF has elicited significant interest from nuclear medicine physicians, radiologists, researchers, and hospital administrators since its introduction at the 2010 Radiological Society of North America (RSNA) meeting.”Once the system receives 510(k) clearance from the FDA, we believe there will be increased interest and clinical use,” he concluded.