FDAnews Device Daily Bulletin

A scientific journal has rejected St. Jude Medical’s demand that it retract a report linking two of its heart leads with patient deaths.

German devicemaker I.E.M. was hit with a warning letter after FDA investigators found shortcomings with medical device report (MDR) procedures and an array of quality “nonconformities” during a recent inspection of the company’s Stolberg, Germany, facility.

Varian Medical Systems has issued a field safety notice concerning its 4D Integrated Treatment Console v 8.6 or 8.8.

Executives in the medical device manufacturing industry predict that a new excise tax and the burden of its related compliance costs will hurt their companies’ bottom lines, according to a survey conducted by KPMG, an audit, tax and advisory firm.

NeuroMetrix reported that it has filed a premarket notification, or 510(k), with the FDA for its SENSUS Pain Therapy device.

Researchers from Princeton and Purdue universities have developed a prototype firewall, called MedMon, which could prevent hackers from manipulating wireless medical devices.

St. Jude Medical announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare and the launch of the Trifecta aortic stented, pericardial tissue valve.

Qiagen today announced its real-time PCR instrument Rotor-Gene Q MDx and the artus Infl A/B RG RT-PCR kit for Influenza A/B has received 510(k) clearance from the FDA.

A federal appeals court said that an Arizona man cannot sue a medical device manufacturer under state law for injuries from a pain pump that he said left him paraplegic.