DOJ Joins Whistleblower Suit Alleging St. Jude Used Phony Trials To Pay MDs
This article was originally published in The Gray Sheet
Executive Summary
The Department of Justice is joining a qui tam action against St. Jude alleging the firm used four post-marketing studies to funnel kickbacks to physicians, according to documents filed in a Boston federal court Aug. 5
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Business News In Brief
EndoGastric Solutions raises $30 million: Maker of endoluminal devices for treating gastrointestinal disease raises $30 million in a "Series F" private placement led by Canaan Partners and Radius Ventures, announced Aug. 30. The proceeds will "support the company through profitability" and fund clinical trials and commercialization efforts for the firm's natural orifice surgery offerings, the company says. Privately held EndoGastric Solutions currently offers its 510(k)-cleared EsophyX and StomaphyX transoral systems for upper gastrointestinal procedures. Ongoing randomized clinical trials are further evaluating EsophyX for transoral incisionless fundoplication to treat gastroesophageal reflux disease and StomaphyX to reduce weight regained after gastric bypass procedures. "Our goal is to establish [natural orifice surgery] as the standard of care for patients with chronic acid reflux whose clinical needs are not met with medical management, and in the future, patients who suffer from obesity," stated CEO Thierry Thaure
Most Device Firms Ready To Comply With AdvaMed Ethics Code
A survey of medical device firms conducted by PriceWaterhouseCoopers suggests most are ready to meet the guidelines laid out in AdvaMed's new code of ethics, which went into effect July 1