The US Food and Drug Administration (FDA) has granted 510(k) clearance to Intelomed’s real-time blood volume measuring device, designed for patients with declining cardiovascular stability.
By utilising proprietary algorithms, the CVInsight device measures and records pulse rate, functional oxygen saturation of arterial hemoglobin as well as the percentage of change in pulse rate and pulse strength.
Intelomed chief researcher and CVInsight inventor 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 said.
"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."
As clinicians are seeking new tools to avoid acute events and improve dialysis treatment, the company is planning to initially use the device in hemodialysis applications.
Intelomed CEO Frank Amoruso said the company believes that the new device will help monitor a patient’s vital signs and cardiovascular health, and have positive effect on the quality of patient care.
"Our Medical Advisory Board consists of very well respected and accomplished physicians that have given us excellent guidance relative to industry needs and market approach," Amoruso said.