FDA clears AtCor blood pressure tool in US
Wednesday, 21 November, 2012
AtCor Medical (ASX:ACG) has won FDA approval for SphygmoCor XCEL, the upgraded version of its cardiovascular diagnostics system.
The company is now cleared to market the systems in the US clinical practice market. CEO Duncan Ross said this is the company's largest potential market for the systems.
Ross said the company plans to file for approval in additional markets this financial year.
SphygmoCor XCEL is the upgraded version of AtCor's central aortic blood pressure and arterial stiffness measurement tool. Improvements include the ability to measure brachial and central aortic blood pressure simultaneously.
The company launched the device in May at the 22nd European Society of Hypertension Congress in London, with the device going on sale in Australia, Europe and four Asian markets.
AtCor first filed for FDA approval to market the device in the US in July.
In October, the company revealed it had picked up a $3.2 million deal to provide SphygmoCor systems to multiple clinical trial sites.
AtCor (ASX:ATG) shares hopped from 7.2c to 7.5c this morning on the back of the news, but are steady back at 7.2c as of around 2.45pm Wednesday.
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