An Ethicon Endo-Surgery-made device has received a mixed review by the FDA, which found it efficacious in one use but not others. At issue was the Sedasys Sytem intended to sedate patients before producers without the involvement of anesthesiologists. Agency reviewers decided the device failed to sedate gastroscopy patients properly. The FDA said Sedasys was successful with patients undergoing colonoscopies, however. Ethicon Endo-Surgery, a unit of Johnson & Johnson, is seeking FDA approval as the first-of-the-kind treatment for patients in colonoscopies and gastroscopies. (Click here for more – a subscription may be required)
“FDA: JNJ Unit’s Sedation Device Successful In Certain Patients” – Wall Street Journal (5/27/09)
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