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."

Viatronix.

Medicsight.

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.

No Comments