Siemens Biograph mCT PET-CT System Receives FDA Clearance

Siemens‘ Biograph mCT, a positron emission tomography-computed tomography (PET-CT) scanner which was introduced at the annual meeting of the Radiological Society of North America (RSNA) in Chicago a few months ago, has now received FDA 510k clearance.

The Biograph mCT enables the quantification of molecular processes in the body. Current applications include cancer imaging, quantification of absolute myocardial blood flow and quantification of amyloid deposits in the brain in patients with dementia.

Some of the highlights of the new system, from the press release:

With conventional technology, clinicians face the issue of variability in quantitative results due to software and hardware challenges. Engineered to overcome these technical and procedural obstacles, the new Biograph mCT offers accurate and reproducible quantification in PET•CT imaging by ensuring optimization of each element of the imaging chain – with an emphasis on the finest volumetric image resolution on the market, daily system calibration, accuracy of attenuation correction using automated co-registration algorithms, and more automated, user-independent and reproducible standardized uptake value (SUV) calculation methods for daily clinical practice.

The new Biograph mCT incorporates Siemens’ unique OptisoHD (High-Definition) Detector System, which features a fine volumetric resolution of only 87 mm. Other innovative technologies include Time of Flight (TOF) and HD•PET, ensuring fast, precise images with minimum radiation dose. With Siemens Quanti•QC, daily system normalization can be performed overnight, calibrating and tuning the system to precisely the right specifications, facilitating consistent and optimal performance, day after day.

Siemens Molecular & Anatomical Registration Technologies (SMART) address the traditional problems of inherent scanner drift and inaccurate attenuation correction through misregistration of anatomical and functional images. To facilitate accurate attenuation correction and reliable quantitative measurements, the new Biograph mCT’s unique patient handling system virtually eliminates differential deflection. The system also features Auto Cardiac Registration that automatically aligns CT and PET heart images and reduces variability between users. Additionally, SMART offers a new form of attenuation correction for neurological images that no longer requires CT data.

Advanced syngo clinical applications provide essential tools to obtain quantifiable measurements in neurology, cardiology and oncology imaging. SUVpeak, new in the syngo.via oncology engine, provides consistent, reproducible quantitative assessments of hot spots. Myocardial blood flow (MBF) can be used as an absolute quantification method to assess balanced disease in all areas of the heart. Additionally, a new quantitative tool in neurology – the syngo.PET Neuro DB Comparison application as part of the syngo.mCT Neurology engine – automatically registers brain data to a FDG PET normal database to aid in the assessment of neurological disorders.

The new Biograph mCT incorporates the Siemens OptisoHD (High-Definition) Detector System, which will feature a volumetric resolution of 87 mm3. Other technologies include Time of Flight and High-Definition PET, ensuring fast, precise images with minimum radiation dose. This enables precise measurements of metabolic processes including the assessment of neurological disease, cancerous tissue and cardiac blood flow.

The scanner itself has a large 78 cm bore, a short tunnel and a 227 kg table capacity allowing for the scanning of bariatric patients. It has a 100 kW CT generator for high quality imaging and HD FoV (field of view). Optional upgrades include 128 slice CT and an expanded PET field of view up to 21.6 cm.

Press release: Siemens’ New Biograph mCT PET-CT System Receives FDA Clearance…

Product page: Siemens Biograph mCT…

Flashback: Siemens Introduces Next-Generation PET-CT System, Biograph mCT