Siemens Healthineers Gains FDA Clearance for Biograph One PET MR Scanner

The U.S. Food and Drug Administration has granted Siemens Healthineers clearance for the Biograph One, its second-generation positron emission tomography/magnetic resonance (PET/MR) imaging scanner that enables simultaneous visualization of organ location, function, and cellular metabolism.

PET/MR can potentially reveal a tumor’s location, as well as its metabolic activity and treatment response. With these capabilities, the Biograph One can impact the rapidly expanding practice of theranostics, which integrates diagnostics and therapy for personalized oncology treatment. Moreover, studies suggest that PET/MR could become a one-stop clinical imaging tool for neurodegenerative diseases such as Alzheimer’s disease,¹ with emerging drug therapies relying on PET scans to confirm an Alzheimer’s disease diagnosis and MR scans to monitor for related side effects. Additionally, new features on the Biograph One enable faster image acquisition times and more efficient workflows than previous generations of PET/MR scanners, according to the company.

Siemens Healthineers introduced the world’s first commercial PET/MR system in 2011 with the Biograph mMR. Benefiting from customer feedback obtained through nearly 14 years of clinical use, the second-generation Biograph One seamlessly integrates PET and MR to reduce operational complications associated with other PET/MR scanners. The new system has features for faster acquisition times and more efficient workflows, and can reduce patient scan times by 50%.² Its 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 (TOF) of 187 picoseconds,³ which is the fastest TOF in PET/MR.⁴ This level of spatial resolution and TOF could increase system sensitivity, for faster examinations and flexible dose administration.

“Over the past few years, we have seen a fundamental shift in personalized medicine. This shift has been driven by new drug developments, theranostics, and advances in technology, accompanied by a surge in the diagnosis of cancer and neurological diseases, especially Alzheimer’s disease,” said Katie Grant, head of Magnetic Resonance at Siemens Healthineers North America. “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.”

Many PET/MR scans are whole-body exams, which often take more than an hour to conduct. With a 35 cm axial FOV digital PET detector—the largest axial FOV in PET/MR4—the Biograph One is ideal for scanning large body regions. A large PET detector reduces acquisition time for whole-body images by requiring fewer bed positions, bringing scan times to less than 30 minutes to fit more typical radiology schedules and support twice as many patients.  

Several AI technologies are embedded within the Biograph One. New to PET/MR, the MyExam Companion intuitive user interface provides radiologic technologists with advanced automation features to simplify the entire scanning workflow. Deep Resolve Boost 2D and 3D image reconstruction technology accelerates image acquisition in addition to removing noise and improving image sharpness. New, flexible BioMatrix Contour XL MR coils resemble blankets and provide effective whole-body patient coverage using fewer coils, reducing setup time and technologist exposure to radiation. An integrated BioMatrix Position Sensor communicates with the system to suggest optimal patient positioning, potentially reducing exam setup time.

Siemens Healthineers is a global provider of healthcare equipment, solutions, and services, with activities in more than 180 countries and direct representation in more than 70. The group comprises Siemens Healthineers AG, listed as SHL in Frankfurt, Germany, and its subsidiaries. The company is principally active in imaging, diagnostics, cancer care, and minimally invasive therapies, augmented by digital technology and artificial intelligence. In fiscal 2025 (ended Sept. 30), Siemens Healthineers employed approximately 74,000 workers worldwide and generated around €23.4 billion in revenue.

References
¹ PET/MR Imaging: New Frontier in Alzheimer’s Disease and Other Dementias. Zhang XY, Yang ZL, Lu GM, Yang GF and Zhang LJ (2017) PET/MR Imaging: New Frontier in Alzheimer’s Disease and Other Dementias. Front. Mol. Neurosci. 10:343. doi: 10.3389/fnmol.2017.00343
² Compared to Biograph mMR. Preliminary data based on an internal single measurement. Patient slot time is defined as time in PET/MR exam room. Data on file.
³ Based on measurements from a single system. Data on file.
⁴ Data on file.