FDA to Reconsider Propofol Sedation System From Ethicon Endo-Surgery

Ethicon Endo-Surgery, a medical device company that appealed an FDA decision not to approve its personalized sedation device, will receive a hearing in December, according to a MedPage Today report.

The company is a unit of Johnson & Johnson that manufactures Sedasys, a computer-assisted sedation system that lets physicians and nurses provide propofol sedation during colonoscopy and endoscopy of the upper GI tract.

The use of propofol is generally limited to anesthesiologists, who are trained to administer general anesthesia. Sedasys would allow non-anesthesiologist physicians and nurses to use the system without an anesthesiologist present.

The FDA rejected the device in 2010 after voted 8-2 in favor of approval in 2009. Ethicon Endo-Surgery filed an appeal with FDA Commissioner Margaret Hamburg, MD, and the FDA granted a hearing for the company before the dispute resolution committee in December.

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