International Technidyne (ITC) has announced the European launch of an in vitro diagnostic (IVD) device for the quantitative measurement of prothrombin time international normalized ratio (PT/INR).
Using a proprietary multi-channel analysis and clot detection technology, the ProTime InRhythm system measures PT/INR using samples collected from fingerstick whole blood or fresh venous whole blood with no additives.
The test system, which is intended for professional use in the management of patients treated with oral vitamin K antagonist therapy, is expected to provide better accuracy and reliability across the reportable range and strengthen clinician confidence in test results.
International Technidyne chief executive officer John Sperzel said the device, like the other systems, provides a solution in the point-of-care anticoagulation monitoring.
"It is the continuing goal of ITC to meet the needs of our customers through product innovation in order to deliver diagnostic devices with lab quality accuracy and precision," Sperzel added.
"Our state-of-the-art design for the ProTime InRhythm maximizes clinical efficiency, providing our customers rapid and reliable results."
The company said it will launch the device in select European markets this week and will exhibit the product at the upcoming Cardiology Congress in Turkey, Point of Care Symposium in Finland and at the Anesthesia Congress in Germany.
The ProTime InRhythm is not cleared by the FDA and is not available for sale in the US.