Navigation Links
Intelomed Receives FDA 510(k) Clearance of CVInsight Medical Device

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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. VirtualScopics Receives Issuance of Influential Patent in Canada
2. Lifeline Biotechnologies Receives Third Software Patent
3. Dehaier Medical Receives SFDA Approval for DHR-CPAP-C5
4. TechPrecision Receives Additional Medical Purchase Orders Exceeding $1.5 Million
5. Sinovac Receives Beijing CDC Tender Award to Supply Seasonal Flu Vaccine Anflu(R) to Beijing Citizens
6. NeuroSigma Receives CE Certification
7. Surefire Medicals Infusion System For Embolization Procedures Receives CE Mark Approval
8. Roche receives FDA clearance for herpes simplex virus type 1 and 2 tests
9. NxStage Patient and Advocate Brian Hess Receives Prestigious Honor from American Association of Kidney Patients
10. AcelRx Pharmaceuticals Receives Fourth and Fifth U.S. Patents for Small-Volume Oral Transmucosal Dosage Forms
11. China Botanic Receives New Patent on its Comprehensive Method to Enhance the Medicinal Value of Schisandra
Post Your Comments:
(Date:11/24/2015)... WuXi PharmaTech (Cayman) Inc. ("WuXi" or the ... capability and technology platform company serving the pharmaceutical, biotechnology, ... China and the United States ... meeting of shareholders held today, the Company,s shareholders voted ... the previously announced agreement and plan of merger (the ...
(Date:11/24/2015)... 24, 2015  In the pharmaceutical industry, companies want ... to quickly uncover new insights, tactics and strategies that ... --> However, organizations often find it ... and ensure that all rules and regulations are met ... major barrier to efficiently launching market research projects is ...
(Date:11/24/2015)... , Nov. 24, 2015  DILON Diagnostics and GE ... an agreement for DILON to distribute GE,s Discovery NM750b ... globe. The signing of this distribution agreement will provide Dilon,s ... Breast Imaging system and is considered an initial step ... healthcare solutions for clinicians and their patients. ...
Breaking Medicine Technology:
(Date:11/24/2015)... Angeles, CA (PRWEB) , ... November 24, 2015 , ... ... explored the different restrictions and variables that determine which patients are or are not ... those patients that have a BMI over 40, are more than 100 pounds overweight, ...
(Date:11/24/2015)... City, UT (PRWEB) , ... November 24, 2015 , ... ... Forbes Magazine. For a business, it is critical that the first impression be positive ... business, they are not likely to buy anything or want to return. They will ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... share their knowledge and experiences at a live taping of the next ... for the Cure of Gastrointestinal Cancers 2015 Symposium at Georgetown University Hotel & ...
(Date:11/24/2015)... ... ... Aided by seed funding from the Ron Foley Foundation, researchers at Western Connecticut ... to detect and treat pancreatic cancer (PC). , WCHN researchers will focus on ... genetic material that is present in the blood of patients with PC. It ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... award for its exceptional customer service: the TrustDale certification. The award recognizes good ... Baltimore stone honing , tile and grout, and hard surface restoration company ...
Breaking Medicine News(10 mins):