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August 17, 2015

FDA grants approval for GE’s low dose CT lung cancer screening

The US Food and Drug Administration (FDA) has authorised GE Healthcare to use a low dose computed tomography (CT) option to screen patients with high risk of lung cancer.

CT option

The US Food and Drug Administration (FDA) has authorised GE Healthcare to use a low dose computed tomography (CT) option to screen patients with high risk of lung cancer.

Early detection with low dose CT in high risk people is likely to improve prognosis and treatment and reduce the number of lung cancer related deaths.

American College of Radiology lung cancer screening committee chair Dr Ella Kazerooni said: "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 programme, and requires collaboration with imaging partners to bring technology to bear for this purpose.

"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 programme."

"The FDA’s clearance of these CT scanners for this purpose illustrates that commitment."

The FDA approval follows the landmark National Lung Screening Trial (NLST), which demonstrated the use of low dose CT screening decisively reduced the mortality rate from lung cancer by 20% compared to use of a chest x-ray.

Conducted at 33 medical institutions with more than 53,000 older healthy patients at high risk due to smoking history, the trial revealed a 6.7% reduction in the rate of death from any cause using low dose CT screening.

All new 64-slice and greater CT scanners, and virtually all 16-slice CT scanners sold by the company are qualified systems and will include the screening option.

Approval enables physicians to use the scanners to deliver low dose, short scan times, and clear and sharp images for the detection of small lung nodules, which are critical in the identification of lung cancer at its earliest stages when it is the most treatable and curable.

The new protocols can use GE’s technologies such as ASiR, ASiR-V and Veo, which are designed to reduce image noise that is undesirable for physicians looking for small nodules.

The US Preventive Services Task Force and the Centers for Medicare and Medicaid Services recommended the use of low dose CT screening for high-risk individuals.

In addition, Medicare granted insurance reimbursement for its beneficiaries who are eligible for the use of low dose CT lung cancer screening in such patients.


Image: GE’s low dose computed tomography (CT) cleared by the FDA for lung cancer screening. Photo: courtesy of General Electric.

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