Asymptomatic HF detection device receives FDA thumbs up

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NI Medical, a biotech company, has received FDA approval for its NICaS CS, a device for the assessment of left ventricular systolic dysfunction (LVSD), which could help physicians detect heart failure (HF) in its pre-clinical, asymptomatic phase.

The Kfar Mallal, Israel-based company said the NICaS device uses impedance technology for measuring cardiac functions like cardiac output, cardiac index, cardiac power, stroke index, total peripheral resistance, etc. The device is characterized by accurate results, revealing a bioequivalence with the thermodilution technique.

A new algorithm, the Granov Goor Index (GGI), has been added to the NICaS, now called NICaS CS. Primary care physicians can now detect LVSD in the pre-clinical or asymptomatic phase during an ordinary physical exam, the company said.