Siemens Healthineers has received clearance from the U.S. Food and Drug Administration for its second-generation PET/MR scanner, the Biograph One.

The new system integrates positron emission tomography and magnetic resonance imaging into a single platform and is designed to streamline diagnostic imaging for oncology and neurology.

The Malvern, Pennsylvania-based company launched its first PET/MR system, the Biograph mMR, in 2011. The updated Biograph One incorporates nearly 14 years of user feedback, with a focus on simplifying operations, reducing scan times, and enhancing image quality. Siemens says the system’s updates cut patient scan times in half compared to earlier PET/MR models.
The Biograph One combines components from the company’s existing imaging technologies: the MR system is based on the Magnetom Vida 3T scanner, while its PET capabilities are derived from the Biograph Vision PET/CT, featuring lutetium oxyorthosilicate (LSO) crystal detectors and a time-of-flight (TOF) performance of 187 picoseconds. According to Siemens, this is the fastest TOF available in PET/MR imaging.

PET/MR systems enable simultaneous anatomical and functional imaging, a combination that supports applications in theranostics and the management of neurodegenerative conditions. As some Alzheimer’s disease therapies rely on PET for diagnosis confirmation and MR for monitoring treatment-related changes, PET/MR could serve as a single-modality solution in those cases.

The Biograph One also includes several workflow enhancements. Its 35 cm axial field of view, currently the largest in PET/MR, allows for faster whole-body scans by minimizing bed repositioning. The system integrates AI-powered tools such as the MyExam Companion user interface and Deep Resolve Boost image reconstruction software, which aims to reduce noise and improve sharpness. The scanner also uses BioMatrix Contour XL coils and an integrated positioning sensor to support more efficient setup and imaging.

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