Updated on 22 November 2012
AtCor Medical gets US FDA approval for SphygmoCor XCEL
Singapore: AtCor Medical, the developer and marketer of the SphygmoCor system which noninvasively measures central aortic blood pressures and arterial stiffness, received US FDA clearance to market its new SphygmoCor XCEL system in the US.
The application for FDA clearance was filed in July 2012. Mr Duncan Ross, AtCor Medical CEO said, "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."
The SphygmoCor XCEL was introduced in the US at the American Society of Nephrology conference in San Diego earlier this month. It has been tailored for use by medical specialists in fields including 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.