Medical Devices Today

MDUFMA Renewal Plan Spreads Fee Burden More Evenly; Senate Panel OKs

From the April 23, 2007 issue of "The Gray Sheet"

Just two days after FDA released its behind-schedule proposal to reauthorize the medical device user fee program, a Senate committee approved the agency's recommendations to collect almost $300 million from manufacturers through 2012.

On April 18, the Senate Health, Education, Labor & Pensions Committee, chaired by Edward Kennedy, D-Mass., voted 15-5 to send the ¹FDA Revitalization Act (S 1082) - including the device user fee ²provisions delivered to Capitol Hill by FDA on the 16th - to the Senate floor. Republican Sens. Michael Enzi (Wyoming), Lamar Alexander (Tennessee), Pat Roberts (Kansas), and Orrin Hatch (Utah) joined the Democrats in the majority.

CMS Proposes Unique Codes For Continuous Glucose Monitoring

From the April 16, 2007, issue of "The Gray Sheet"

CMS is proposing to establish unique codes for continuous glucose monitors, a decision that could help manufacturers secure reimbursement from both Medicare and private payors.

If the proposal is finalized in November, the creation of three separate level-II HCPCS codes for subcutaneous disposable sensors, external transmitters and receivers would reverse the agency's decision last year to deny unique codes for the new technology.

New Usability Standard Aims To Help Firms Institute Human Factors Programs

From the April 2007 issue of "The Silver Sheet"

After decades of being relegated to an afterthought for some manufacturers, the concept of incorporating human factors into medical device development has finally gained some traction, several FDA officials say.

Usability is becoming such a widely accepted industry concern that it will soon be the subject of a brand new international standard that will give firms advice on how to build and maintain their own human factors programs.

Physicians Predict COURAGE Will Reduce U.S. Stent Procedures About 5%

From the April 9, 2007, issue of "The Gray Sheet"

The highly publicized COURAGE trial will cause a roughly 5% reduction in the number of stent procedures in the United States, according to Dartmouth Medical School's Aaron Kaplan, M.D., and Carl Szot, M.D.

Kaplan, director of Dartmouth's cardiac catheterization lab, and Szot, chief of cardiology at the Cheshire Medical Center, Keene, N.H., spoke about the COURAGE results in an April 5 conference call sponsored by Bernstein Research.

Devices In Drug Land: Med-Tech Firms Try To Break Into Pharma Territory

From the April 2, 2007, issue of "The Gray Sheet"

Medical device companies are targeting everything from headaches to psychiatric disorders and from digestive diseases to cardiac conditions in an effort to win over just a portion of these and other multibillion-dollar drug-dominated markets.

They have their work cut out for them, experts and company reps suggest. Physician turf battles, patient reluctance and arguments about cost to the health care system are just a few of the likely barriers firms face when trying to move into to a therapeutic market already claimed by pharmaceuticals.