FDA Clears GE Healthcare Scanners for Low Dose CT Lung Cancer Screening

Strategic Insights -

GE Healthcare, a US-based medical technology company, has become the first to receive clearance from the US FDA for its low dose computed tomography (CT) lung cancer screening option. This clearance enables physicians to use the company's CT scanners, specifically those with 64-slice or greater models, for annual lung cancer screening in high-risk individuals. The screening is recommended by both the US Preventative Services Task Force and the Centers for Medicare and Medicaid Services. Furthermore, Medicare has approved insurance reimbursement for eligible beneficiaries.

Key Takeaways:

  • GE Healthcare is the first company to receive FDA clearance for a low dose CT lung cancer screening option.
  • The clearance enables physicians to use qualified GE Healthcare CT scanners for annual lung cancer screening in high-risk individuals.
  • The US Preventative Services Task Force and the Centers for Medicare and Medicaid Services recommend the use of low dose CT lung cancer screening for high-risk individuals.
  • Medicare has approved insurance reimbursement for eligible beneficiaries.
  • Early detection of lung cancer through low dose CT screening can prevent a substantial number of lung cancer-related deaths.
  • Physicians will have access to new low-dose screening reference protocols tailored to the CT system, patient size, and current medical and governmental recommendations.

The GE Healthcare scanners that are cleared for this indication include 64-slice and greater CT models. These scanners are designed to deliver low dose, short scan times, and clear and sharp images for the detection of small lung nodules. The National Lung Screening Trial demonstrated that the use of low dose CT screening reduced the mortality rate from lung cancer by 20% compared to chest X-ray screening. Additionally, the trial showed a 6.7% reduction in the rate of death from any cause using low dose CT screening.

Statistics:

  • 20% reduction in mortality rate from lung cancer using low dose CT screening (National Lung Screening Trial)
  • 6.7% reduction in the rate of death from any cause using low dose CT screening (National Lung Screening Trial)
  • 53,000 older, otherwise healthy patients at high-risk due to smoking history participated in the National Lung Screening Trial
  • 50% of participants were screened using low dose CT, 50% were screened using chest X-ray
  • Medicare has approved insurance reimbursement for eligible beneficiaries
  • GE Healthcare sells qualified systems, including 64-slice and greater CT scanners, for low dose CT lung cancer screening

Sources:

  • M2 PHARMA-August 17, 2015-FDA Clears GE Healthcare Scanners for Low Dose CT Lung Cancer Screening
  • US Preventative Services Task Force
  • Centers for Medicare and Medicaid Services
  • Medicare
  • National Lung Screening Trial