Industry Insight

CDRH has consolidated its postmarket surveillance guidances into a single document to make it easier to access information. The new document, released today, mostly takes the form of a FAQ. Issues covered include the policy criteria CDRH uses to determine whether to impose postmarket surveillance, the responsibilities of the various review team members, and notification issues. With postmarket issues becoming more of a priority at CDRH, this document should come in handy.

A study in the Journal of the American Medical Association found significant complication rates -- 5.8% of 3000 patients -- in procedures to remove implantable cardioverter-defibrillators after they were recalled, the New York Times reports. That raises questions as to whether such surgeries are really needed. What this really highlights is the need to prevent implantations of a model as soon as problems with it are identified.

Almost immediately after closing its deal to acquire Gudiant Corp., Boston Scientific Corp. found its credit rating cut to barely above junk status by the three major credit rating agencies, the Associated Press wrote in a report available on devicelink.com . The move could make it harder for the firm to borrow money in the future.

A women's health organization is questioning whether an industry-funded study asserting the safety of silicone breast implants drew the proper conclusions. In a release available on devicelink.com , the National Research Center for Women & Families noted that two studies, one funded by silicone maker Dow Corning and one by the National Cancer Institute, both found elevated rates in deaths from respiratory cancer among women with silicone implants.

The winners of the 2006 Medical Design Excellence Awards can be found in the new issue of MD&DI . A panel of jurors has given awards to 26 products in 10 categories.

Proposed changes in the Medicare payment structure could produce drastic cuts in reimbursement for high-priced procedures such as implanting stents and defibrilators, the Boston Globe reports. There is now a 60-day comment period, but it doesn't take a rocket scientist to know what industry's response will be. AdvaMed has already come out against it.

Medtronic, Inc. announced that it has received FDA approval for the world's first insulin pump with real-time continuous glucose monitoring . The Minimed Paradigm will help patients take immediate action to correct or prevent problems related to glucose level.