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FDA gives clearance to Siemens smallest PET/CT, Biograph Horizon

Press releases may be edited for formatting or style | January 14, 2016
Siemens Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Biograph Horizon positron emission tomography/computed tomography (PET/CT) system, which offers premium performance at an attractive total cost of ownership. The system leverages proven PET/CT technology to help providers address more clinical indications in oncology, neurology, and cardiology, while also introducing new efficiencies and cost savings.

Biograph Horizon enables physicians to visualize small lesions early. The system's 4 mm LSO crystals scintillate faster and have a higher light output than BGO crystals,3 resulting in high resolution and better image quality, and enabling Time-of-Flight acquisition.4 Biograph Horizon's capabilities are valuable for many indications, like lung cancer – the most common PET/CT indication, at 29 percent of the total exam mix.5 As more than half of lung cancer patients are diagnosed at a late stage6 and have an increased likelihood of distant metastasis, more detailed patient data can help clinicians more accurately stage disease and evaluate therapy response, contributing to more effective care pathways.

The recent decision of the U.S. Preventive Services Task Force (USPSTF) to recommend annual lung cancer screening with low-dose CT for high-risk adults has the potential to generate more suspicious findings, for which biopsies are often performed to confirm malignancy. However, 43 percent of these biopsies come back negative,7 and 1 in 6 result in an adverse event such as lung collapse,8 which can cost up to 28 times more than the cost of incorporating PET/CT into the evaluation following lung cancer screening.7 High-contrast, high-resolution PET/CT with Time-of-Flight can help clinicians identify additional diagnostic procedures, like biopsy, that are most appropriate for each lung cancer patient, supporting improved patient outcomes, lower procedure costs and reduced liability risks. To help providers address the growing demand for CT lung exams, Biograph Horizon also can be used as a shared service to support CT overflow, reduce patient wait times and enable scheduling flexibility.
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As the smallest1 PET/CT system with the lowest1 power requirements, Biograph Horizon minimizes the initial capital investment and is a smart choice for institutions looking to replace their current PET/CT scanner, as the system will fit into virtually any existing PET/CT exam room. Biograph Horizon offers low operating and maintenance costs to help manage the total cost of ownership, with automated technologies such as gentle system warm-up and automatic standby that extend the system's economic life in addition to reducing power consumption. And Siemens' Guardian Programâ„¢ predicts system issues before they occur, lowering costs related to unplanned downtime by 43 percent.9

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