Philips receives FDA 510(k) clearance of CT imaging solutions for lung cancer screening

by PRNewswire

AMSTERDAM, April 26, 2016 /PRNewswire/ -- Royal Philips (NYSE: PHG; AEX: PHIA) today announced that any hospital or healthcare facility with one of its indicated computed tomography (CT) models can now become a lung cancer screening center. Philips' suite of CT solutions has achieved 510(k) clearance from the Food and Drug Administration (FDA) for low-dose lung cancer screening (LCS). The suite includes 27 CT and PET/CT models, as well as integrated software and services, which together are the industry's most comprehensive lung cancer screening solution.

Lung cancer is the leading cause of cancer death among both men and women in the U.S.[1], and the source of one in four cancer deaths[2]. Screenings are recommended by the Center for Medicare & Medicaid Services (CMS) to help identify the disease earlier in high risk populations when treatment can be more successful. Early detection using this method has been shown to not only improve prognosis and treatment, but decrease death rates up to 20 percent[3]. In addition, if diagnosed in stage one, patients can have up to a 49 percent chance of surviving, compared to a diagnosis at stage three where the survival rate is as low as 5 percent[4]."Lung cancer is the number-one cancer killer in America, taking more American lives than colon, breast and prostate cancer combined, and early detection is key to fighting this terrible disease," said Brady J. McKee, radiologist at Lahey Hospital and Medical Center, a pioneer in the early detection of lung cancer, featuring the largest clinical lung cancer screening program in the country. "The work Philips has done to improve a provider's screening capability not only benefits individual patients, but hospitals at each step of their Lung Cancer Screening program implementation and execution, which is often a very complicated process that includes community outreach, physician education, patient and data management, and reporting."

Philips' low-dose CT solutions now give healthcare organizations of varying clinical and economic needs — from community hospitals to multi-facility health systems — the ability to build robust lung cancer screening programs. Through its integrated radiology solutions and services, Philips can work with healthcare executives to better assess availability of existing scanners and to establish an enterprise-wide lung cancer program that will deliver advanced patient care and access.

"Our robust portfolio of CT solutions offers our customers in the United States a turnkey approach to lung cancer screening," said Rob Cascella, CEO, Diagnostic Imaging, Philips. "This is a complementary offering to utilize existing systems to bring low-dose CT screening to healthcare facilities of all sizes who want to drive earlier detection for patients at high risk for lung cancer."

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