FDA Clears Siemens Somatom CT Systems for Low-Dose Lung Cancer Screening

The U.S. Food and Drug Administration (FDA) has ranted 510(k) clearance to Erlangen, Germany-based Siemen Healthcare’s Somatom computed tomography (CT) systems for low-dose lung cancer screening. Siemens now offers a comprehensive approach to low-dose lung cancer screening—both on all of Siemens’ new CT scanners sold as well as on the company’s installed base of non-end-of-support systems—using standard low-dose lung protocols that are already delivered on Siemens CT scanners. With the Somatom Scope 16-slice CT system to the ultra-premium Somatom Force, Siemens now makes low-dose lung cancer screening broadly available to its customers.

“Lung cancer screening represents one of the most significant opportunities to improve population health through earlier detection and improved follow-up opportunities for high-risk patients,” said David Pacitti, president of Siemens Healthcare North America. “That’s why Siemens pursued the most expansive indication for lung cancer screening, bringing this valuable tool to all varieties of our current Somatom CT scanners.”

According to Siemens, with this indication, an imaging modality that has long been a benchmark diagnostic tool for symptomatic patients is becoming a viable screening tool for a subset of high-risk asymptomatic patients. For the right patient population, this technology can have a significant impact on mortality for a disease that is often diagnosed too late.

Siemens has also released a mobile imaging solution for lung cancer screening in recognition of the fact that one of the challenges to widespread adoption of screening services is access to care, especially for people living in rural areas. The Mobile Somatom Scope CT is a self-powered mobile CT with on-board diesel generator that is ready to scan within minutes of parking. No commercial driver’s license is required to drive the vehicle, reducing complexity in logistics. Equipped with a high-speed wireless connection, the Mobile Somatom Scope CT is ready for fast and easy image transfer.