A few years ago, ITC, the company that makes the ProTime, ProTime 3 and Hemochron meters, tried to get FDA approval for a newer INR tester, the ProTime InRhythm. For some reason, the ProTime InRhythm didn't get the approval, so it's not able to sell the meter in the United States.
Information about the system was, for some time, only available by googling the name of the product.
I checked the ITC Site (ITCMED.COM), looking for information on the Hemochron, and saw the InRhythm on the front page of the site.
In April 2013, the company started selling the InRhythm into certain European markets. I'm assuming that the countries where the meter is being sold have an approval process in place, and that the InRhythm has obviously passed them.
Although little information is currently available for this meter, it's interesting to expect that the European approval, and a growing population of users may help to convince the FDA to re-examine the meter. (OTOH -- foreign markets could keep ITC pretty busy. They may not really NEED the US market to do well).
Information about the system was, for some time, only available by googling the name of the product.
I checked the ITC Site (ITCMED.COM), looking for information on the Hemochron, and saw the InRhythm on the front page of the site.
In April 2013, the company started selling the InRhythm into certain European markets. I'm assuming that the countries where the meter is being sold have an approval process in place, and that the InRhythm has obviously passed them.
Although little information is currently available for this meter, it's interesting to expect that the European approval, and a growing population of users may help to convince the FDA to re-examine the meter. (OTOH -- foreign markets could keep ITC pretty busy. They may not really NEED the US market to do well).
