Officials for J&J announced the FDA’s decision during a company conference call after the company released its first quarter results, according to the report. The FDA sent the company a “Not Approvable” letter, along with suggestions the company could consider for the product.
J&J is appealing the FDA’s decision. The anesthesia system is made by J&J Ethicon EndoSurgery division and is approved for use in the European Union for upper GI procedures and colonoscopy and for colonoscopy in Canada, according to the report.
Read the AP’s report on the FDA’s rejection of J&J’s computer-assisted anesthesia device.
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