Philips receives FDA 510(k) clearance of CT imaging solutions for lung cancer screening to help hospitals of all sizes drive earlier detection and improve patient care decisions

April 26, 2016

  • Philips’ suite of low-dose CT solutions now cleared for lung cancer screening
  • Early detection of the top cause of cancer related deaths in the U.S. can help reduce mortality rates

 

Amsterdam, The NetherlandsRoyal 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 deaths2. 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 percent3. 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 percent4.

 

“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.”

 

Philips lung cancer screening solutions also provide several benefits for patients and referring physicians, including:

 

  • Personalized management of radiation dose – Offering one of the most accelerated screening approaches in the industry, the 27 models of Philips CT and PET/CT solutions qualified with the indications for use to perform CT lung cancer screening also utilize active dose management tools.
  • Greater insights throughout the process – Referring physicians are better able to manage the process from end-to-end through “control center” software tools that enable digital access to patient tracking data that proves insight into scheduling, results and follow-up activities.
  • Advanced image data sharing and analytics – Through its IntelliSpace Portal, Philips offers one of the most comprehensive solutions for detection, diagnostics and therapy follow up. To address the increasing interest in pulmonary care, the latest version, IntelliSpace Portal 8.0, now includes the new CT Lung Nodule Assessment (LNA) application designed for a more efficient and longitudinal workflow to provide additional clinical decision support.

 

The Philips commitment to innovative radiology solutions includes improving services and continuing to engage with radiology customers, delivering integrated software, solutions and services that resonate with their specific needs. Philips provides radiology practices with the critical insights needed to transform care, enabling practices to be more efficient and effective, while shaping positive clinical, financial and operational environments. This commitment helps to improve people’s health and enable better care across the entire health continuum.

 


1 Centers for Disease Control and Prevention. National Center for Health Statistics. CDC Wonder On-line Database, compiled from Compressed Mortality File 1999-2012 Series 20 No. 2R, 2014.

2 American Cancer Society, Key Statistics for Lung Cancer, 2016

3 N Engl J Med, 2011; 365:395-409. National Lung Screening Trial research team. Reduced lung cancer mortality with low dose computed tomographic screening.

4 J National Cancer Institute, 100, no.9 (2008): 630-641; Oncology Roundtable interviews and analysis.

 

For further information, please contact:

Adrienne Smith

Philips Diagnostic Imaging

Tel: +1 781-277-1170

Email: Adrienne.Smith@philips.com

 

Kathy O’Reilly

Philips Group Communications

Tel: +1 978-221-8919

Email: Kathy.oreilly@philips.com

@kathyoreilly

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips’ wholly owned subsidiary Philips Lighting is the global leader in lighting products, systems and services. Headquartered in the Netherlands, Philips posted 2015 sales of EUR 24.2 billion and employs approximately 104,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.