Devices & Diagnostics Letter

In a case that could significantly impact how devicemakers publicly report adverse events, several U.S. Supreme Court justices were critical last week of Matrixx Initiatives’ argument that adverse events do not have to be reported to a company’s shareholders until they become statistically significant.

While devicemakers are rushing to meet the demand for wireless medical technology and smartphone applications, the Federal Communications Commission (FCC) is looking for ways to stretch the nation’s limited spectrum that makes those devices work.

In the largest criminal penalty imposed on a devicemaker for violations involving the Federal Food, Drug and Cosmetic Act, Boston Scientific’s Guidant division will pay more than $296 million in fines and forfeiture and be placed on three years’ probation.

Rumors of an $11 billion buyout bid by Johnson & Johnson (J&J) spiked Smith & Nephew’s stock 13 percent last week, but neither company is commenting on whether the speculation is true.

Citing uncertainties about the device regulatory pathway, many venture capitalists (VCs) expect little growth in investments in the medical device industry this year, according to a national survey.

In its first step toward covering MRIs for patients with implanted pacemakers or cardioverter defibrillators, the Centers for Medicare & Medicaid Services (CMS) may be overly prescriptive in the type of clinical trials it will cover, cardiac-device makers say.

Some innovative diagnostic tests may never make it to market unless changes are made to the current reimbursement system, the Biotechnology Industry Organization (BIO) says.

The FDA now has the ability to track health outcome information for 60 million Americans, as the first phase of its Sentinel program draws to a close.

Orthocon has received a warning letter because a principal investigator in a 2007 clinical trial of its Orthostat-L hemostatic bone putty failed to adhere to the selection criteria for subjects.

A warning letter, and the increasing regulation it represents, may be the end of the line for a family-owned device distributor in California.

To address several issues on a Form 483, Peregrine Surgical stopped distributing its adjustable laser probe and voluntarily recalled the product, but the FDA says that’s not enough.

Verichem Laboratories has received a warning letter for failing to validate the design of some of its diagnostic kits under defined operating conditions.