Submitted by kBLASTER Team on
by Fink Densford for MassDevice.com
GE Healthcare (NYSE:GE) said today the FDA granted it 510(k) clearance for low-dose lung cancer screenings using its compatible computed tomography devices.
The Centers for Medicare and Medicaid services recommends the low-dose CT lung cancer screening and approved insurance reimbursement for high-risk patient beneficiaries who undergo the procedure, GE Healthcare said.
“Bringing low dose CT screening to patients at a high risk for lung cancer will reduce death from the most deadly cancer worldwide. 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,” Dr. Ella Kazerooni of the American College of Radiology said in a press release.
GE Healthcare claims it is the 1st company to receive FDA clearance for low-dosage lung cancer CT screening. Lung cancer is the 3rd most common cancer, and the leading cause of cancer deaths, according to GE.
“This is the 1st time in history that any CT device has received FDA clearance for any screening indication. 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,” GE Healthcare molecular imaging & CT CEO Henry Hummel said in a press release.
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