A Medical Device Daily
In its web statement on the tentative decision not to continue reimbursements for virtual colonoscopies, the Centers for Medicare & Medicaid Services says that it currently covers annual fecal occult blood tests; flexible sigmoidoscopy every four years; screening colonoscopy for persons at average risk for colorectal cancer every 10 years, or for persons at high risk for colorectal cancer every two years; barium enema every four years as an alternative to flexible sigmoidoscopy or colonoscopy; and other procedures the Secretary of Health and Human Services "finds appropriate based on consultation with appropriate organizations."
In its statement, the agency goes on to list the technologies 510(k)-cleared by the FDA for use in CT colonography, describing these as "post-processing software devices used with CT of the colon."
• CT Colonography II, GE Healthcare.
• syngo Colonography software package with extended functionality, Siemens Medical Solutions.
The statement also says that Medicsight has submitted an application to the FDA seeking an additional 510(k) clearance.