Royal Philips Electronics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its whole-body Ingenuity PET/MRI system
The system is designed so the patient table rotates between each modality to scan a patient, enabling the system to perform both standalone MR and hybrid PET/MR studies. This delivers added flexibility by eliminating the need to invest in multiple scanners, while cutting down on throughput time and improving patient comfort since the patient can remain on the same table for both tests, according to the company.
The system features Philips' proprietary Time-of-Flight (TOF) technology, Astonish TF, designed to enhance image quality by reducing noise and providing increased sensitivity. It is combined with the superior soft-tissue contrast of 3-tesla MR to image disease as it proliferates in soft tissue.
The system has already received the CE Mark in Europe. To date, Philips has sold 13 systems worldwide, and Mount Sinai in New York City and University Hospitals/Case Western Reserve University in Cleveland will house the first systems in the U.S.
