FDAnews Device Daily Bulletin

Medicare will cover patients enrolled in Medtronic’s pivotal trial of the CoreValve system, under an Aug. 10 revision to the Centers for Medicare & Medicaid Services’ (CMS) coverage policy on transcatheter aortic valve replacement (TAVR).

Medical devicemakers should report all adverse events in premarket clinical trials and any device deficiencies that might lead to a serious adverse event, according to the Global Harmonization Task Force’s (GHTF) final guidance on reportable events.

St. Jude Medical Inc., a maker of heart devices, has realigned its product divisions into new operating units: one for implantable electronic systems and another for cardiovascular and ablation technologies.

A medical device distributor has filed a libel claim against FairWarning, the consumer group Public Citizen and several other parties, claiming they made false statements about the company’s sales of a fat-melting device called the Lipotron 3000.

People with depression often cycle through several drugs before they find one that helps.

Patients with drug-resistant hypertension may have a new alternative for reducing their blood pressure, according to a study of Abbott’s RX Herculink Elite device.

A Roseville, Calif., medical technology company founded by a former space-suit inventor and fighter pilot has been given permission to market a cooling helmet designed to lower patient body temperatures during the critical minutes after an injury and in hospital intensive care units.

Quest Diagnostics, the world’s leading provider of diagnostic testing, information and services, today announced the availability of a new laboratory test that identifies molecular changes to cervical cells that increase the likelihood a woman may develop cervical cancer.