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Intelomed non-invasive blood volume measuring device wins FDA nod

Intelomed has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new real-time blood volume measuring device, CVInsight.

The new device, which uses proprietary algorithms, measures and records pulse rate, functional oxygen saturation of arterial hemoglobin as well as percentage of change in pulse rate and pulse strength.

Intelomed chief researcher Jan Berkow said the non-invasive device will help physicians to look into patient’s declining cardiovascular stability much earlier than some current medical standards.

"With this early indication, the clinician may be able to determine what action to take well in advance, rather than reacting to recognition measures after the event has occurred," Berkow added.

"One major challenge facing trauma surgeons and clinicians is the ability to non-invasively measure the circulatory system’s blood volume adequacy in real-time.

"I believe this could be a very significant step in patient care, especially in the areas of hemodialysis, cardiology, and trauma."