Also there is a Troponin device from Trinity Bio which has been put on hold just last month .. reason.. basically their suppliers changed a formulation and it was not picked up and it caused issues with test results.. their FDA troponin trials are now on hold until end of 2015 before their device may get FDA approval..
Another point to make here from this mornings discussion on the CE mark is that Trinity gained the CE mark in September 2014 and by October 2014 their FDA trials are on hold for a very very simple issue that should never have occurred and one which could not be prevented by CE accreditation imvho as its just too generalised and has no specific ability to scrutinise companies in detail ... imvho CE mark is fit for general consumer goods but imo should stay out of medical industry and leave that to the FDA (best of whats available and they have specific industry know how and attention to detail in this field).
POC1/philips are so ahead of the game it amazing.. how so.. they built in a control test dot in each cartridge that runs automatically when the cartridge is inserted to check the "health" of the cartridge to put it in simple terms .. if there is an issue it alerts the user and cartridge is disposed and the insert a new one..
POC1 imvho is actually so far ahead of their competitors with this device that their competition are still years behind them.. this signing alone will put ADO on the map internationally for years to come imvho..
We just need them to show their hand and let ADO announce them..
ADO Price at posting:
12.0¢ Sentiment: Hold Disclosure: Not Held
