Medical Devices Today

Startups Persevere Toward Gaining Artificial Liver Approval

Full article reprinted from "The Gray Sheet" - June 9, 2008

The potential market opportunity for an artificial liver keeps players in the game, even though many companies have tried and failed in the past.

Firms Look To Clinical Guidelines To Boost Prostate Cryosurgery Market

Article preview from "The Gray Sheet" - June 9, 2008

Find out why device manufacturers are saying that new "best practice" statements citing cryosurgery as a treatment option for men with prostate cancer could help boost the use of the technology beyond its modest penetration rate.

PFO Closure: Challenges and Opportunities

Why have device manufacturers who have successfully introduced a number of Patent foramen ovale (PFO) closure devices in Europe, had difficulty conducting randomized trials to gain US market approval?

In Search of the Perfect Aortic Endograft

Why is the aortic endograft market so complex and challenging? Understand how endovascular aortic repair has struggled and how endovascular surgeons are forging ahead. Find out which companies have endografts in development and who to watch. Full article included with FREE ISSUE of Medtech Insight - Download Now.

Riegel v. Medtronic At Supreme Court: Common Law Against Federal Statute

This article is reprinted from "The Gray Sheet" – November 12, 2007

A major case impacting the medical device industry's vulnerability to product liability suits will land in the U.S. Supreme Court next month and legal scholars predict the outcome will be a close call.

Riegel v. Medtronic will be argued in Washington, D.C., Dec. 4 following the plaintiff's appeal of a 2006 federal appeals ruling that Medtronic is not liable for injuries to a patient that resulted when one of the company's catheters burst during the course of a procedure (see chart: "¹Case Background").

Medtronic's victory was in large part due to the appeals court's support of the federal pre-emption defense - that FDA's premarket approval of the device design and its labeling protects the company from lawsuits in state courts.

When Corporate Integrity Agreements Multiply, Firms Know What To Expect

From the June 25, 2007, issue of "The Gray Sheet"

Orthopedic companies will likely be among the next device firms subject to corporate integrity agreements with the HHS Office of Inspector General, and stakeholders say there are clues as to what they should expect.

Several large hip and knee implant manufacturers reportedly could reach a settlement with the U.S. Department of Justice related to anti-kickback violations as early as this summer.

Biomet, Johnson & Johnson/DePuy, Smith & Nephew, Stryker and Zimmer received subpoenas from DoJ in 2005 as part of a major investigation into the industry's financial relationships with physicians.

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.

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.