UPDATED Nov. 30, 2015, with details on FDA clearance for Somatom low-dose CT.
Siemens Healthcare (NYSE:SI) said it won 510(k) clearance from the FDA for its Multitom Rax robotic advanced X-ray scanner, which is designed to function across multiple clinical areas, and for its Somatom low-dose CT scanner for lung cancer.
The low-dose lung cancer screening clearance covers Siemens Healthcare’s entire Somatom line of 7 separate CT scanners, the company said.
“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,” Siemens Healthcare North America president David Pacitti said in prepared remarks. “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.”
Malvern, Pa.-based Siemens Healthcare said the Multitom Rax is designed to cover examinations ranging from emergency medicine and interventional to pain management and orthopedics, using 1 room and a single X-ray system. The system is the 1st to provide #d natural weight-bearing images, the company said.
“With the Multitom Rax, Siemens is proud to introduce the world’s first twin robotic X-ray system,” X-ray products vice president Martin Silverman said in prepared remarks. “This universal X-ray system delivers unprecedented versatility for health care facilities. Now, clinicians can perform a multitude of imaging exams in one room without moving the patient. With the Multitom Rax, we’re opening a new chapter in X-ray technology.”