Posted on 01/06/2009 in Medical Company Product News Ethicon has received positive feedback about its first computer-assisted personalised sedation device, the Sedasys System.
It integrates drug delivery and patient monitoring to enable propofol to be administered in a way that is tailored to the patient's individual needs.
The Food and Drug Administration's (FDA's) Anaesthesiology and Respiratory Therapy Devices Advisory Committee voted in favour of the technology being employed by nurse teams and physicians during the screening and diagnosing of colorectal cancer and the upper gastrointestinal tract.
Conditions of the recommendation by the panel included only using the system for adult patients aged 70 and under, as well as ensuring there is a suitable training programme in place to educate staff on how to use the device.
Vice-president of Ethicon's clinical and regulatory affairs Dr Kenneth Sumner said he looks forward to working with the FDA ? which has the final decision regarding the product's approval - in completing the regulatory review process.
He noted: "There is strong clinical support that the Sedasys System reduces the risk of over-sedation, which may help make sedation more predictable and reliable for physician/nurse teams."
A subsidiary of Johnson & Johnson, Ethicon develops and markets medical devices for minimally invasive and open surgical procedures.Other news stories from 01/06/2009
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