Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Ethicon Endo-Surgery has submitted a premarket approval application to the FDA for the Sedasys System, a computer-assisted personalized sedation system.
Subscribe to our email newsletter
The Sedasys System is intended for use by physician/nurse teams to administer minimal to moderate propofol sedation to patients undergoing screening and diagnostic procedures for colorectal cancer (colonoscopy), and disorders of the upper gastrointestinal tract.
The premarket approval submission includes results from a multi-center prospective, randomized, controlled trial of 1,000 patients that compared the safety and effectiveness of the Sedasys System to the current standard of care for sedation in routine endoscopic procedures, physician-administered benzodiazepine and opioids.