FDA Clears New PET/MRI System from Siemens Healthineers

Offering a combination of AI features, enhanced scanning efficiency and simultaneous anatomical and functional visualization imaging, the Biograph One PET/MRI system has garnered 510(k) clearance from the FDA.

The Biograph One PET/MRI platform supports the use of theranostics in detecting and addressing oncologic and neurological diseases, such as Alzheimer’s disease, according to Siemens Healthinees, the manufacturer of the Biograph One PET/MRI system. The company said the device combines visualization of tumor location with metabolic insights and facilitates monitoring of treatment.

Siemens Healthineers said other attributes of the Biograph One PET/MRI system include high spatial resolution and the fastest time of flight (187 nanoseconds) for PET/MRI. For whole-body exams, the company noted the system’s 35 cm axial FOV digital PET detector and the capability of reducing whole-body scan times to less than 30 minutes.

One of the AI features with the Biograph One PET/MRI platform is Deep Resolve Boost 2D and 3D image reconstruction, which enhances image sharpness and removes noise while accelerating PET/MRI image acquisition, according to Siemens Healthineers.

“Patients experience a long, arduous pathway to answers and treatment. The Biograph One is the culmination of over a decade of experience in harnessing the diagnostic power of these two imaging worlds into one single modality, resulting in one truly patient-centric pathway for every single patient.” said Katie Grant, the head of magnetic resonance at Siemens Healthineers North America.