RE: Just reading up8 May 2017 18:39
FDA approval will firstly be in metastatic breast cancer, but clinical trials will also need to be successfully completed in that application before sales can commence. The ovarian cancer clinical trial data will (if successful) validate the Parsortix system for clinical use, so that clinical sales can then start in Europe. When FDA approval is given in the ovarian cancer application sales can also start in the US.
The machines are being sold currently into the research market, not yet the much bigger clinical market.