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Fdanewsdevicedailybulletin

April 19, 2012

Vol. 9 No. 78

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Journal Stands by St. Jude Leads Study; Medtronic Pulled into Fray

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

Maker of Blood Pressure Monitors Gets Warning for Quality Deficiencies

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. Read More

Incorrect Information Delivery Leads to Device Safety Notice

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

KPMG Survey: New Tax Could Hit Medical Device Companies Hard

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. Read More

NeuroMetrix Files 510(k) for SENSUS Pain Therapy Device

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

Researchers Create Prototype Firewall to Protect Medical Devices

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

St. Jude Medical Launches New Trifecta Heart Valve in Japan

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. Read More

FDA Clears Qiagen’s Rotor-Gene Q MDx Platform, Influenza A/B Assay

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. Read More

Appeals Court: Arizona Man Can’t Sue Medtronic

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. Read More