Devices & Diagnostics Letter

The device industry and congressional allies are considering using the Medical Device User Fee Act (MDUFA) reauthorization package or other legislation as a vehicle to repeal the medical device tax before it can take effect in January 2013.

Smith & Nephew has agreed to pay the U.S. government $22.2 million to settle allegations it bribed Greek doctors to encourage the use of its orthopedic products.

The government’s decision to drop charges against all four Stryker officials indicted in a bone product off-label promotion scheme could serve as a “cautionary flag” in future cases, attorneys for one of the men say.

A Centers for Medicare & Medicaid Services (CMS) decision to cover transcatheter aortic valve replacement (TAVR) in patients with inoperable severe symptomatic aortic-valve stenosis could spur uptake of Edwards Lifesciences’ Sapien valve, which was approved late last year.

Merit Medical Systems must submit a new 510(k) for its Laureate hydrophilic guidewires after altering a coating on the device, an FDA warning letter states.

A recent court of appeals ruling in Walker v. Medtronic appears to further protect devicemakers from liability in state courts when an FDA-approved product injures a patient.

Devicemakers could submit de novo applications without first receiving a 510(k) turndown under a measure now before the Senate’s Committee on Health, Education, Labor, & Pensions (HELP).

Rx Air, a Texas-based maker of massive medical air purifiers, was handed an FDA warning letter with eight observations, including lack of established procedures for validating filter tests.

A British cardiac device company earned an FDA warning letter over its failure to establish medical device reporting (MDR) procedures.

Allergan will not pursue efforts to expand the use of its Lap-Band gastric surgery device to adolescents and will stop selling the device to clinics that promote it through marketing firm 1-800-GET-THIN, the company said in a quarterly earnings call.

A host of violations related to current good manufacturing practices (cGMPs), including failure to adequately validate packaging and sterilization processes, has landed PhotoMedex — a Montgomeryville, Pa.-based maker of burn and wound dressings — an FDA warning letter.

The Mexican government has declassified nearly 1,700 medical devices, clearing the way for regulator COFEPRIS to move forward on a significant backlog of device registrations.

Citing the availability of safer alternatives, the European Commission is proposing a near-total ban on mercury measuring devices, beginning Aug. 1.