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The investigator in two clinical trials of the same device told the FDA he did not know how to access study data and did not know which patients were enrolled, according to a recent warning letter.
A newly published clinical study suggests that a drug-coated balloon treatment may be a viable alternative to stenting to avoid recurrent in-stent restenosis -- the re-narrowing of the coronary artery after stent surgery to expand it.
By issuing new reimbursement rates for oxygen and oxygen equipment, the Centers for Medicare & Medicaid Services (CMS) has "significantly increased the payment amounts for oxygen from what it had originally proposed," the American Association for Homecare said Nov. 8.
The Centers for Medicare & Medicaid Services (CMS) earlier this month released final rules on 2007 payments rates for the outpatient prospective payment system, ambulatory surgical center reimbursement and the Medicare physician fee schedule.
Devicemakers need to design products that will work in the high-tech hospital environment of the future, experts said at a conference earlier this month.
Industry leaders remain skeptical about a proposed mandatory unique device identification (UDI) system that is part of a new postmarket transformation initiative at CDRH.
Genentech and Tanox announced last week plans for Genentech to acquire Tanox, a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology, for $20 per share for a total cash value of approximately $919 million.
With Democrats taking control of the House of Representatives for the first time since 1994 and the Senate for the first time since 2001, the healthcare agenda will now be in the hands of members who have been critical of HHS and FDA policy in the past, meaning changes for the FDA and industry may be on the way.