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FDA Grants 510(k) Clearance for Cardiac Output Device
A hemodynamic monitoring device for measuring a patient’s cardiac output in intensive care units or the operating room has received 510(k) clearance from the FDA.
Retia Medical’s Argos monitor uses “multibeat analysis” algorithms and signal processing, which employ a blood pressure waveform to produce a model of an adult patient’s circulation. The monitor will provide clinicians with accurate data to help them track the delivery of oxygen and maintain optimal fluid status in high-risk surgical and critically ill patients. In addition, the system integrates with current vital-sign monitors and common electronic medical records platforms.
Many monitors fail to accurately track changes in cardiac output when fluid and vasoactive drug therapy are administered. The Argos device and algorithms avoid these frustrating effects that can cause inaccuracies in other hemodynamic monitors.
By connecting directly to a vital-sign monitor for information, the Argos monitor eliminates the need for disposables with each use. Over the long-term, the cost of owning such a device can be much less expensive than other hemodynamic monitoring systems.
Source: FierceBiotech.com, December 17, 2018