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Devices Oncology Radiology FDA

 News Release - August 17, 2015

GE Healthcare First to Receive FDA Clearance for Low Dose CT Lung Cancer Screening

Lung cancer is the leading cause of cancer-related deaths in the United States

Early detection with low dose CT can improve prognosis and treatment and reduce mortality rates for patients with a high risk of lung cancer

WAUKESHA, Wis.--(Healthcare Sales & Marketing Network)--GE Healthcare is proud to be the first company with a low dose computed tomography (CT) lung cancer screening optioni that is cleared by the U.S. FDA for lung cancer screening.ii Both the U.S. Preventative Services Task Force (USPSTF) and the Centers for Medicare and Medicaid Services (CMS) recommend the use of low dose CT lung cancer screening for high-risk individuals.iii, iv Additionally, Medicare has approved insurance reimbursement for its beneficiaries who are eligible for the use of low dose CT lung cancer screening in high-risk patients.v Early detection from an annual lung cancer screening with low dose CT in high-risk persons can prevent a substantial number of lung cancer–related deaths.iv

“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 committee on lung cancer screening, American College of Radiology. “Performing low dose CT with attention to high image quality at the lowest radiation exposure to detect early cancer is at the core of a successful screening program, and requires collaboration with imaging partners to bring technology to bear for this purpose. The FDA’s clearance of these CT scanners for this purpose illustrates that commitment.”

Physicians using low dose CT for lung cancer screening will now have access to the benefits from a screening indication, including GE Healthcare’s new low-dose screening reference protocols. These new protocols are tailored to the CT system, patient size, and the most current recommendations from a wide range of professional medical and governmental organizations. Now, qualified GE Healthcare CT scanners can be confidently used by physicians within their FDA cleared indications for use, delivering low dose, short scan times, and clear and sharp images for the detection of small lung nodules. These nodules are critical in identifying lung cancer at its earliest stages when it is the most treatable and

The landmark National Lung Screening Trial (NLST) was conducted at 33 medical institutions with over 53,000 older, otherwise healthy patients at high-risk due to smoking history. Half of the participants were screened using low dose CT, the other half were screened using chest X-ray. The trial demonstrated that the use of low dose CT screening decisively reduced the mortality rate from lung cancer by 20 percent compared to use of chest X-ray. The NLST also revealed a significant 6.7 percent reduction in the rate of death from any cause using low dose CT screening.vii

All new 64-slice and greater CT scanners, and virtually all of the 16-slice CT scanners that GE Healthcare sells are qualified systems and will include the screening option. The solution that GE Healthcare developed is also available to thousands of qualified GE scanners currently in use, increasing access to the quality scanners that satisfy both patient and physician needs. The new protocols are able to utilize GE Healthcare’s industry-leading technologies such as ASiRTM, ASiR-VTM and VeoTM that are designed to reduce image noise, which is undesirable for physicians looking for small nodules.

In the United States, lung cancer is the third most common cancer and the leading cause of cancer deaths; it kills almost twice as many women as breast cancer and three times as many men as Prostate Cancer. Survival rates from lung cancer are highly correlated to its initial stage at the time of first diagnosis. The overall five year survival rate for lung cancer is among the lowest (17 percent) of all types of cancer but is significantly higher when the cancer is diagnosed at an early stage (54 percent). However, currently only 15 percent of lung cancer cases are diagnosed at such an early stage.viii, ix The use of low dose CT lung cancer screening increases this percentage of early stage detection, providing patients a much better prognosis.

“This is the first time in history that any CT device has received FDA clearance for any screening indication,” said Henry Hummel, president and CEO of Molecular Imaging and CT at GE Healthcare. “GE Healthcare is thrilled to be the first CT vendor who can help clinicians establish low dose CT lung screening programs in order to continue improving the health of their patients. Healthcare providers are looking for solutions beyond just imaging equipment; we look forward to helping them establish low dose CT lung cancer screening programs that will inevitably save lives through earlier diagnosis and treatment for patients.”

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

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i The FDA has cleared the following qualified GE Healthcare CT scanners to receive the new low dose CT Lung Cancer Screening Option: LightSpeed 16, BrightSpeed Elite, LightSpeed Pro16, Optima CT540, Discovery CT590 RT, Optima CT580, Optima CT580 W, Optima CT590 RT, LightSpeed Xtra, LightSpeed RT16, LightSpeed Pro32, LightSpeed VCT, LightSpeed VCT XT, LightSpeed VCT XTe, LightSpeed VCT Select, Optima CT660, Revolution EVO, Discovery CT750 HD, Revolution Discovery CT, Revolution GSI, Revolution HD, and Revolution CT.

ii The Low Dose CT (LDCT) Lung Cancer Screening Option (LCS) for qualified GE Systems is indicated for using low dose CT for lung cancer screening. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or professional medical society.

iii The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years.

iv Moyer V. Screening for Lung Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014;160:330-338.

v CMS has determined that those beneficiaries who are 55-77, asymptomatic, have a tobacco smoking history of at least 30 pack-years, are a current smoker or one who has quit smoking within the last 15 years; and receives a written order for LDCT lung cancer screening may receive an annual screening for lung cancer with low dose computed tomography (LDCT), as an additional preventive service benefit under the Medicare program. - CMS: Decision Memo for Screening for Lung Cancer with low dose Computed Tomography (LDCT) (CAG-00439N)

vi The International Early Lung Cancer Action Program Investigators. Survival of Patients with Stage I Lung Cancer Detected on CT Screening. N Engl J Med 2006;355:1763-71.

vii The National Lung Screening Trial Research Team. Reduced Lung-Cancer Mortality with low dose Computed Tomographic Screening. N Engl J Med 2011;365:395-409.

viii American Cancer Society. Cancer Facts and Figures 2015.

ix National Cancer Institute. Surveillance, Epidemiology, and End Results Program (SEER). SEER Stat Fact Sheets: Lung and Bronchus Cancer.

Source: GE Healthcare

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