Ethicon Endo-Surgery Reaches Settlement With FDA Over Propofol Device

Ethicon Endo-Surgery, a division of Johnson & Johnson, has reached a settlement with the FDA over the agency's denial of sedation device Sedasys, according to a MedPage Today report.

The company has withdrawn its request to go before the FDA's dispute resolution panel in December, according to the report. Sedasys is a computer-assisted sedation system that gives physicians and nurses the ability to provide sedation with propofol during colonoscopy and endoscopy of the upper gastrointestinal tract without the supervision of an anesthesiologist.

The device was endorsed by the FDA in 2009 and later rejected in 2010. Ethicon Endo-Surgery appealed the decision to FDA Commission Margaret Hamburg, MD, who gave the company a hearing scheduled for Dec. 14.

The FDA has agreed to reopen the company's premarket approval application and "review it expeditiously," according to the report.

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