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GE first to get FDA nod for low dose CT lung cancer screening

por Gus Iversen, Editor in Chief | August 17, 2015
CT Rad Oncology Population Health Primary Care X-Ray
GE Healthcare has received FDA clearance for a lung cancer screening option that utilizes low dose CT. The protocol, which GE says is the first to be approved for CT lung screening, takes into account the latest recommendations from a wide range of medical and regulatory organizations to generate an image of the lung — and any existing cancer nodules — with minimal radiation exposure to the patient.

The value of lung cancer screening with low dose CT was realized in the National Lung Screening Trial (NLST) which looked at 53,000 patients across 33 facilities — healthy older adults who had a history of heavy smoking. Half of those patients were screened with low dose CT, the other with X-ray. The NLST determined that low dose CT lowered the mortality rate by 20 percent.

GE's screening protocol is custom-tailored to its different scanner models and may be implemented on any of its 64-slice or greater CT scanners and the majority of the company's 16-slice systems. It will also work in conjunction with GE's noise reduction technologies, ASiRTM, ASiR-VTM and VeoTM.
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Both the U.S. Preventative Services Task Force (USPSF) and CMS recommend low-dose screening for patients at high risk of developing lung cancer, and Medicare reimburses screening for qualified beneficiaries.

"Bringing low dose CT screening to patients at a high risk for lung cancer will reduce death from the most deadly cancer worldwide," said Dr. Ella Kazerooni, chair of the committee on lung cancer screening, American College of Radiology, in a statement.

In the U.S. lung cancer is the third most common cancer behind breast and prostate but is more fatal by far. Screening, and early detection, can dramatically increase the likelihood of surviving the disease.

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