The FDA's Center for Device and Radiological Health, or CDRH, has published a set of memos for applications seeking to make significant changes to medical devices that already have premarket approval. The 180-day PMA memos for design changes are part of the CDRH's transparency initiative.
Medical imaging business leaders raised their concerns to presidential advisers about cuts to Medicare payments for the use of X-rays, MRIs and PET scanners. They say the reduction in Medicare fees could discourage physicians from using the scans and prevent patient access to the latest technology.
The CMS has proposed ceasing payments for self-referred services, targeting joint ventures between doctor groups and hospitals, and the rules could go into effect by January. Critics say self-referrals lead to unnecessary exams and procedures, but others say doctors' increased investment can improve medical services.
The FDA plans to schedule an advisory panel review for Abbott Laboratories' Xience drug-coated coronary stent, an Abbott executive said. The company, which hopes to introduce the device in the U.S. in the first half of 2008, said it's working with the agency to schedule the meeting "as expeditiously as possible."
An FDA advisory panel has scheduled a meeting on Oct. 10 to consider approval for Medtronic's Endeavor drug-coated stent. Medtronic has said it hopes to launch the stent in the U.S. market by the end of the year.