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iNTELOMED Receives FDA 510(k) Clearance of CVInsight Medical Device


9/20/2012 10:53:24 AM

WEXFORD, Pa., Sept. 20, 2012 /PRNewswire/ -- Intelomed, Inc., a developer of non-invasive medical devices and technology for monitoring fluid adaptation for patients well or poorly perfused, announced today that it has received FDA 510(k) clearance on its CVInsight medical device.

CVInsight processes a pulse wave through proprietary algorithms to measure and display vital information such as functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate of adult and pediatric patients.

Intelomed's CEO, Frank Amoruso, commented: "We are very excited about the introduction of CVInsight. We believe it will have a meaningful impact on the ability to monitor a patient's vital signs and cardiovascular health, thereby having an extremely positive effect on the quality of patient care."

CVInsight will provide clinicians and other caregivers with a utility for recording trends of pulse rate, SpO2, and the percentage of change in pulse rate and pulse strength derived from data recorded with a pulse oximeter. A clinician may use this data as an indication of a clinical event based upon their experience and training. Intelomed's Chief Researcher and inventor of CVInsight, Jan Berkow, said; "CVInsight will provide physicians with a non-invasive tool that gives a critical 'insight' into a patient's declining cardiovascular stability - much earlier than some current medical standards by trending of such values. 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. 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."

Intelomed is confident that CVInsight will have utility across many areas of healthcare, but the company will initially focus on specific applications where research shows that the greatest needs exist. One of the first applications is hemodialysis, where clinicians seek tools to improve treatment and avoid acute events that put the patient at risk and often prevent a successful dialysis treatment. Mr. Amoruso adds, "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. We are fortunate to have such consummate thought leaders on our team."

About Intelomed

Intelomed is a privately held medical technology company, established in 2005 and headquartered in Pittsburgh, Pennsylvania. They are focused on developing innovative software and non-invasive devices for monitoring cardiovascular stability in real-time. Intelomed's ability to provide intelligent operational medicine via their technology will directly and positively impact the initial areas of dialysis, cardiology, and trauma.

Safe Harbor Statement

Certain statements in this release are "forward-looking" and as such are subject to numerous risks and uncertainties. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain additional capital in order to grow our business, our ability to engage additional sales representatives, the success of such additional sales representatives, the need to obtain FDA clearance and CE marking of new products, the acceptance of new products by doctors and hospitals, larger competitors with greater financial resources, the need to keep pace with technological changes, our dependence on third party manufacturers to produce our goods on time and to our specifications, and implementation of our sales strategy.

SOURCE Intelomed, Inc.



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