Angle Gets De Novo Clearance for its Cancer-Detecting System

The FDA has granted De Novo clearance for Angle’s Parsortix system for gathering cancer cells and analysis of blood samples from metastatic breast cancer patients.

The Parsortix system makes it possible to conduct repeat non-invasive biopsies to assess cancer status, according to the Surrey, UK-based company.  

Clinical trial data showed that the system “was able to effectively capture a single cancer cell in a blood sample for analysis,” said James Reuben, University of Texas MD Anderson Cancer Center, a principal investigator in the Parsortix study.

The De Novo device provides medtech and pharma companies “an FDA cleared platform on which to develop new medical solutions,” the company said.

The FDA has deemed Parsortix a Class II device, which includes devices that pose a moderate to high risk to patients or users. The category covers about 43 percent of all devices and requires special controls to provide “reasonable assurance” of their safety and effectiveness.