Parsortix cancer cell separation device regulatory update

Angle submitted a 510(k) application to FDA for its Parsortix cancer cell separation device for the harvesting and molecular analysis of large cells such as circulating tumor cells (CTCs) from patient blood. Angle said it anticipates a decision from FDA by the end of 3Q14. In December, Parsortix received CE Mark approval in the EU for clinical use in cancer treatment. Last March, the company launched the device for research use to a limited number of users worldwide (see BioCentury, March 11, 2013 & Jan. 13, 2014). The microscale device separates cells on the basis of size and/or surface interactions. ...