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Sept. 5, 2012

Vol. 9 No. 174

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Lawyer: Unsealed Qui Tam Suit May Throw New Spin on CDRH Email Case

The unsealing of a hence unknown 2009 qui tam (whistleblower) lawsuit filed against the FDA by seven former CDRH scientists embroiled in an ongoing email monitoring scandal may provide evidence the employees were sharing proprietary information, one legal expert says. Read More

Class I Recall Issued on Dialysis Tools

The FDA has classified Fresenius Medical Care’s recent warning of the company’s GranuFlo and NaturaLyte dialysis products a Class I recall. Read More

Are St. Jude’s Layoffs Related to the Medical Device Tax?

St. Jude Medical’s coming overhaul and massive layoffs were attributable partly to the 2.3 percent medical device tax taking effect Jan. 1. Read More

Justice Department Asks for Review of Questionable Defibrillator Surgeries

In what experts say is a novel legal tactic to resolve hundreds of ongoing investigations simultaneously, the Justice Department is emailing hospitals across the country with instructions to examine questionable implantable defibrillator surgeries on Medicare patients and estimate potential penalties under the False Claims Act. Read More

Hunt Launched for Life-Changing Medical Devices

Science guru and breakfast radio presenter Adam Spencer has described it as “The New Inventors meets The Apprentice meets ER.” Read More

SFDA Destroys Wrongly Stored Medical Devices Worth $23.5 Million

The Saudi Food and Drugs Authority (SFDA) has revealed that it destroyed this year medical equipment worth $23.5 million stored in humid and hot places that made them ineffective. Read More

Researchers Develop Wirelessly Powered Cardiac Device

Stanford researchers have developed a cardiac device that fits on a pin head and derives power from radio waves from outside the body. Read More

Belgrade Medical Device Manufacturer Gets $25 Million Infusion

A Belgrade-based company that makes medical devices has received $25 million from a New York investment firm. Read More