AtCor files FDA application for cardiovascular monitor

AtCor Medical (ASX:ACG) has filed for FDA approval for SphygmoCor XCEL, the upgraded version of its cardiovascular disease risk assessment and monitoring tool.

The company expects to receive FDA clearance to market the product in the US by the end of the year.

SphygmoCor XCEL is a non-invasive central aortic blood pressure and arterial stiffness monitoring system. The new design allows simultaneous brachial and central aortic blood pressure measurement.

AtCor launched SphygmoCor XCEL in Australia, Europe and four Asian markets in May.

AtCor CEO Duncan Ross said the new product has been well received since this launch. He added that the company is “looking forward to gaining US FDA market clearance so we can commence selling in our largest market.”

He said AtCor plans to file for approval in additional markets beyond the US this financial year.

AtCor Medical was founded in 1994, and listed on the ASX with a $15 million IPO in 2005. The company is headquartered in Sydney, and also has operations in the US and Europe.

AtCor (ASX:ACG) shares were trading unchanged at $0.060 by around 3:30pm on Monday.