FDA gives clearance to Siemens smallest PET/CT, Biograph Horizon
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.
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 Program™ predicts system issues before they occur, lowering costs related to unplanned downtime by 43 percent.9
"More than 65 percent of health care institutions in the U.S. that are planning to purchase a new PET/CT system in the near future will be either replacing such a system or adding an additional unit,5" says Mario Zeiss, Vice President, Global Marketing and Sales, Siemens Healthcare, Molecular Imaging. "Biograph Horizon's premium PET/CT technology and small footprint make it ideal for this market. The system's versatility and scalability helps providers serve a broader mix of patients and expand into new service lines, creating competitive advantage and new opportunities for growth."
To increase productivity and time spent with patients, Biograph Horizon simplifies staff's daily routine by automating manual tasks and offering protocol-based exams. For example, the Quanti•QC feature can run quality control procedures overnight, scans can be performed in as fast as 5 minutes, and reconstruction runs alongside acquisition for image delivery just 30 seconds after the scan.10
Configured specifically for Biograph Horizon, syngo.via® Molecular Imaging Workplace4 is a cost-effective image processing solution that can expand with providers' clinical needs. The solution offers automated tools to instantly visualize diagnostic information, measure with confidence and report more comprehensively. syngo.via automates prefetching, preprocessing, and display and comparison of previous findings for up to 45 percent11 faster processing. Also, ALPHA technology provides automatic registration with organ-based recognition capabilities. EQ•PET12 normalizes standard uptake value (SUV) measurements across different scanners for more precise calculation of changes in tumor uptake.
¹ Based on competitive information available at time of publication. Data on file.
2 Biograph Horizon is not commercially available in all countries. Due to regulatory reasons its future availability cannot be guaranteed. Please contact your local Siemens organization for further details.
3 Pepin, et al (2004). Properties of LYSO and Recent LSO Scintillators for Phoswich PET Detectors. IEEE Transactions on Nuclear Science, 51, 3.
4 Optional.
5 IMV 2014 PET Imaging Market Summary Report.
6 U.S. National Institutes of Health, National Cancer Institute, SEER Cancer Statistics Review, 1975-2011.
7 " Costs of the Diagnostic Workup for Lung Cancer: A Medicare Claims Analysis," International Journal of
Radiation Oncology, 2014.
8 Population-Based Risk for Complications After Transthoracic Needle Lung Biopsy of a Pulmonary Nodule:
An Analysis of Discharge Records," Annals of Internal Medicine, 2011.
9 Quantification based on Siemens ticket hour statistics from active Guardian-capable systems in global installed base of AX, CT, MR and MI business units from FY2013.
10 Results may vary.
11 For oncology diagnosis. Compared to previous versions.
12 Requires calibration to NEMA parameters for measurement normalization.
For more information, please visit www.usa.siemens.com/horizon
Contact for journalists
Jeff Bell
Siemens Healthcare
Phone: 610-448-6348; E-mail: jeffrey.t.bell@siemens.com
Follow us on Twitter: www.twitter.com/SiemensHealth
Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world's largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of gas and steam turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2015, which ended on September 30, 2015, Siemens generated revenue of €75.6 billion and net income of €7.4 billion. At the end of September 2015, the company had around 348,000 employees worldwide. Further information is available on the Internet at www.siemens.com.
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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.
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 Program™ predicts system issues before they occur, lowering costs related to unplanned downtime by 43 percent.9
"More than 65 percent of health care institutions in the U.S. that are planning to purchase a new PET/CT system in the near future will be either replacing such a system or adding an additional unit,5" says Mario Zeiss, Vice President, Global Marketing and Sales, Siemens Healthcare, Molecular Imaging. "Biograph Horizon's premium PET/CT technology and small footprint make it ideal for this market. The system's versatility and scalability helps providers serve a broader mix of patients and expand into new service lines, creating competitive advantage and new opportunities for growth."
To increase productivity and time spent with patients, Biograph Horizon simplifies staff's daily routine by automating manual tasks and offering protocol-based exams. For example, the Quanti•QC feature can run quality control procedures overnight, scans can be performed in as fast as 5 minutes, and reconstruction runs alongside acquisition for image delivery just 30 seconds after the scan.10
Configured specifically for Biograph Horizon, syngo.via® Molecular Imaging Workplace4 is a cost-effective image processing solution that can expand with providers' clinical needs. The solution offers automated tools to instantly visualize diagnostic information, measure with confidence and report more comprehensively. syngo.via automates prefetching, preprocessing, and display and comparison of previous findings for up to 45 percent11 faster processing. Also, ALPHA technology provides automatic registration with organ-based recognition capabilities. EQ•PET12 normalizes standard uptake value (SUV) measurements across different scanners for more precise calculation of changes in tumor uptake.
¹ Based on competitive information available at time of publication. Data on file.
2 Biograph Horizon is not commercially available in all countries. Due to regulatory reasons its future availability cannot be guaranteed. Please contact your local Siemens organization for further details.
3 Pepin, et al (2004). Properties of LYSO and Recent LSO Scintillators for Phoswich PET Detectors. IEEE Transactions on Nuclear Science, 51, 3.
4 Optional.
5 IMV 2014 PET Imaging Market Summary Report.
6 U.S. National Institutes of Health, National Cancer Institute, SEER Cancer Statistics Review, 1975-2011.
7 " Costs of the Diagnostic Workup for Lung Cancer: A Medicare Claims Analysis," International Journal of
Radiation Oncology, 2014.
8 Population-Based Risk for Complications After Transthoracic Needle Lung Biopsy of a Pulmonary Nodule:
An Analysis of Discharge Records," Annals of Internal Medicine, 2011.
9 Quantification based on Siemens ticket hour statistics from active Guardian-capable systems in global installed base of AX, CT, MR and MI business units from FY2013.
10 Results may vary.
11 For oncology diagnosis. Compared to previous versions.
12 Requires calibration to NEMA parameters for measurement normalization.
For more information, please visit www.usa.siemens.com/horizon
Contact for journalists
Jeff Bell
Siemens Healthcare
Phone: 610-448-6348; E-mail: jeffrey.t.bell@siemens.com
Follow us on Twitter: www.twitter.com/SiemensHealth
Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world's largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of gas and steam turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2015, which ended on September 30, 2015, Siemens generated revenue of €75.6 billion and net income of €7.4 billion. At the end of September 2015, the company had around 348,000 employees worldwide. Further information is available on the Internet at www.siemens.com.
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