J&J's Ethicon Endo-Surgery Receives Canadian, European Approval for Computer-Assisted Sedation System Rejected by FDA

Ethicon Endo-Surgery, a Johnson & Johnson company, announced that the SEDASYS System, the first computer-assisted personalized sedation system, was granted a CE Mark for the European Union for routine colonoscopy and screening of the upper gastrointestinal tract and was granted regulatory approval by Health Canada for use by healthcare professional teams during routine colonoscopy, according to an Ethicon news release.

"We are excited by these regulatory approvals and the opportunities they provide to bring the SEDASYS System to the Canadian and European markets," Karen Licitra, company group chair and worldwide franchise chair for Ethicon, said in the release. "We believe the SEDASYS System has the potential to improve the sedation experience for patients and clinicians during routine colonoscopy procedures, and we look forward to the launch of the System in these markets, as early as the end of this year."

The FDA recently sent Ethicon a "Not Approvable" letter for the SEDASYS System, a move supported by the American Society of Anesthesiologists.

Read the Ethicon release about the SEDASYS System (note: this link is no longer available on Ethicon's website).