Siemens’ SAFIRE Iterative Reconstruction Protocol Cleared by FDA

Siemens Healthcare has announced that its computed tomography (CT) iterative reconstruction algorithm SAFIRE – Sinogram Affirmed Iterative Reconstruction – has been cleared for domestic sale by the U.S. Food and Drug Administration (FDA). This new generation of image reconstruction software and hardware, developed within Siemens Healthcare’s initiative Agenda 2013, allows for a robust reduction of radiation dose1 in CT examinations. Additionally, the use of projection raw data during the iterative image improvement process enables a reduction of subtle image artifacts and therefore a further improvement in general image quality.

SAFIRE helps users reduce dose by up to 60% compared to previous filtered back projection techniques, as documented in the FDA clearance letter. “From a clinical perspective, SAFIRE helps to significantly reduce radiation exposure across the whole portfolio of clinical applications and continues to demonstrate Siemens’ commitment to deliver the best possible patient care at the lowest possible radiation dose,” said Elliot Fishman, MD, CT section chief of radiology at Johns Hopkins Medical Institutions in Baltimore, and a member of the SIERRA (Siemens Radiation Reduction Alliance) dose expert panel.

SAFIRE’s extremely fast reconstruction speed of 20 images per second enables reconstruction of a typical high-resolution thorax examination of 30 cm in just 15 seconds. With this as-yetunmatched reconstruction performance, SAFIRE can be applied routinely in clinical practice.

SAFIRE ties into the Siemens Healthcare global initiative Agenda 2013, which among other measures focuses on driving the development of next-generation healthcare IT.

“Siemens once again demonstrates its commitment to radiation dose reduction in computed tomography,” said Stefan Ulzheimer, PhD, Director of Global Scientific Marketing, Siemens Healthcare Computed Tomography. “Independent scientific validation of our products has always been a cornerstone of our development process. We are extremely excited that the FDA now recognizes these efforts and, to our knowledge, for the first time has allowed a quantitative dose reduction claim for an iterative reconstruction technique in the industry.”

SAFIRE is available for Siemens SOMATOM Definition Flash and SOMATOM Definition AS CT systems and will be available on the Definition DS in mid-2012. In the meantime, Siemens’ current iterative reconstruction method, IRIS (Iterative Reconstruction in Image Space), will remain available for SOMATOM Definition dualsource systems and additionally, due to the overwhelming response to IRIS in the Siemens CT install base, for SOMATOM Emotion 16 (2007) and SOMATOM Sensation 40, 64 and Open CT systems.

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