Siemens Healthineers has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) for Biograph One, a second-generation PET/MR imaging scanner.
The scanner allows for simultaneous visualization of organ location, function, and cellular metabolism to potentially reveal a tumor’s location, as well as its metabolic activity and response to treatment.
Siemens Healthineers introduced the world’s first commercial PET/MR system in 2011 with the Biograph mMR, it said. Biograph One integrates PET and MR to reduce operational complications associated with other PET/MR scanners and can reduce patient scan times by 50%, according to the firm.
The MR technology is based on the premium Magnetom Vida 3 Tesla scanner, and its digital PET detector with lutetium oxyorthosilicate (LSO) crystals is founded on the high-end Biograph Vision PET/CT scanner. The PET/CT technology generates images with high spatial resolution and a time-of-flight of 187 picoseconds, Siemens added.
Biograph One also features a 35-cm axial field-of-view digital PET detector for scanning large body regions. This aims to reduce acquisition time for whole-body images by requiring fewer bed positions. The company said this can bring scan times to less than 30 minutes.
Several AI technologies are embedded within Biograph One, including MyExam Companion user interface for advanced automation features, Deep Resolve Boost 2D and 3D image reconstruction technology, BioMatrix Contour XL MR coils that provide whole-body patient coverage using fewer coils, and an integrated BioMatrix Position Sensor that communicates with the system for patient positioning.
