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AtCor Medical product gets US FDA approval

26 November 2012 | Regulatory | By BioSpectrum Bureau

AtCor Medical product SphygmoCor XCEL system gets US FDA approval

The new SphygmoCor XCEL system has been cleared for sale in the US market

The new SphygmoCor XCEL system has been cleared for sale in the US market

Singapore: Australia-based AtCor Medical, the developer and marketer of the SphygmoCor system that noninvasively measures central aortic blood pressures and arterial stiffness, has received US Food and Drug Administration (FDA) clearance to market its new SphygmoCor XCEL system in the US. The application for FDA clearance was filed in July 2012.

"This is an important step forward for AtCor, as it paves the way for us to sell XCEL systems in the valuable US clinical practice market, which is also our largest potential market. Importantly, the XCEL system is much simpler to use and provides invaluable data for clinicians to properly manage patients with hypertension and other cardiovascular related diseases," said Mr Duncan Ross, CEO, AtCor Medical. SphygmoCor XCEL is tailored for use by medical specialists in fields such as cardiology, hypertension, nephrology (renal or kidney disease) and endocrinology (diabetes).

The system is already available for sale in Europe, Australia, and four Asian markets, including India. The company plans to file applications for regulatory approval to sell into additional markets during the current financial year.

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