FDA Clears Siemens Healthineers' Biograph One PET/MR Scanner

Siemens Healthineers has secured clearance from the U.S. Food and Drug Administration for its Biograph One PET/MR scanner. This advanced imaging system, notable for its integration of positron emission tomography and magnetic resonance imaging, creates a combined view of anatomical and functional data within a single session. This dual capability is instrumental in identifying tumor location and assessing metabolic activity and treatment response, impacting personalized oncology treatments through integrated diagnostics and therapy, known as theranostics.

The Biograph One is a second-generation device building on Siemens' first commercial PET/MR system introduced in 2011, the Biograph mMR. Enhanced by years of customer feedback, the Biograph One streamlines operations with faster image acquisition and efficient workflows, reducing patient scan times by up to 50% when compared to earlier models. Its MR technology leverages the premium Magnetom Vida 3 Tesla scanner, while the PET component incorporates a digital detector with lutetium oxyorthosilicate crystals, refining image resolution and time-of-flight measurements to 187 picoseconds—the fastest in its category.

A significant feature of the Biograph One is its ability to handle extensive body scans, thanks to a 35 cm axial field of view—the largest in PET/MR systems. This capability significantly decreases the time required for whole-body scans, often completing them in less than 30 minutes, aligning well with standard radiology schedules and enhancing patient throughput. AI-based innovations such as the MyExam Companion interface facilitate intuitive operation, while Deep Resolve technology ensures rapid, high-quality image construction.

Besides, the scanner is equipped with BioMatrix Contour XL MR coils that ensure comprehensive body coverage with fewer coils, minimizing setup time and operator exposure. An integrated BioMatrix Position Sensor improves patient alignment, further streamlining the examination process.

Siemens Healthineers emphasizes the role of its Biograph One in the ongoing evolution of personalized medicine, especially in light of heightened cancer and neurological disease diagnoses, including Alzheimer's disease. The integration of AI and advanced scanning technologies are pivotal in setting new standards for patient-centered diagnostic pathways.