ARTICLE | Clinical News

APPY1 regulatory update

April 7, 2014 7:00 AM UTC

Venaxis submitted a 510(k) application to FDA for APPY1 to identify patients that are at low risk for appendicitis. The company is also seeking concurrent de novo classification of the test by FDA. FDA's de novo pathway is an alternative path to market for devices that are lower risk and may not require a PMA but are of a new type and would not be cleared via the 510(k) pathway. ...