Navigation Links
Somanetics Announces New FDA 510(K) Clearance
Date:4/16/2009

- Labeling expanded to include improved patient outcomes and

real-time measurement accuracy -

TROY, Mich., April 16 /PRNewswire-FirstCall/ -- Somanetics Corporation (Nasdaq: SMTS) announced today a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its INVOS(R) Cerebral/Somatic Oximeter. The new labeling allows a claim of improved patient outcomes after surgery when the INVOS System is used to manage therapies in patients above 2.5 kilograms (kg) at risk for reduced or absent blood flow. Additionally, its indications for use now reflect the INVOS System's ability to generate accurate real-time measurements of blood oxygen saturation in this same patient population, in addition to its previous clearance as a trend monitor in any individual.

These changes make the INVOS System the only commercially-available cerebral/somatic oximeter backed by an improved patient outcomes claim, and the only cerebral/somatic system cleared for use on neonates less than 2.5 kg.

The INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter noninvasively monitors site-specific blood oxygen levels to help surgical and critical care teams protect their patients against brain and vital organ area damage, or even death.

"The clinical data we submitted and subsequent 510(k) clearance demonstrate that improved patient outcomes are possible with the use of our INVOS System, and that our device can benefit cardiac surgery patients as well as high-risk general surgery patients, such as the elderly undergoing major abdominal surgery," explains Bruce Barrett, Somanetics' president and CEO.

Marc S. Kanchuger, MD, Associate Professor and Chief of Cardiothoracic Surgery and Transplant Anesthesia at NYU Medical Center adds, "I'm not surprised by the FDA's decision. We use the INVOS System routinely in all our cardiac surgeries in an effort to protect patients from ischemic brain complications. I suspect today's news will spark further adoption of the technology by the medical community."

Barrett continues, "Our expanded indication reinforces the device's applicability for on-label treatment of patients at any weight. For patients above 2.5 kilograms, including adults, children and most infants, our proprietary algorithm generates accurate, real-time measurements for immediate use by the care team. In patients below 2.5 kilograms, which is extremely common in our neonatal market, clinicians may use our device on-label as a trend monitor."

The labeling also removed "not demonstrated in disease states" from the indication for patients weighing greater than 2.5 kg, and includes additional 510(k) language on these three points:

  • The measurement of regional cerebral oxygen saturation (rSO2) is an indication of whether oxygen delivery to the brain is adequate. Prolonged declines in rSO2 are indicative of, or may result in, potential brain injury.

  • When used as an indication of compromised cerebral oxygenation, interventions to return the patient's rSO2 to baseline using the INVOS System have been shown to improve outcomes after surgery.

  • In neonates, infants and children, cerebral and somatic rSO2 provide noninvasive indications of oxygen changes in the cerebral and peripheral circulatory systems and may provide an early indication of oxygen deficits associated with impending shock states and anaerobiosis.

About Somanetics

Somanetics Corporation (Nasdaq: SMTS) develops, manufactures and markets the INVOS(R) Cerebral/Somatic Oximeter which noninvasively provides accurate, real-time blood oxygen measurements in patients greater than 2.5 kilograms, and trend monitoring of this parameter for individuals of any weight. The INVOS System is the only commercially-available cerebral/somatic oximeter proven to improve outcomes in patients above 2.5 kilograms, and is the only cerebral/somatic oximeter system cleared for use on neonates less than 2.5 kg. Surgeons, anesthesiologists and other medical professionals can use data provided by the INVOS System, in conjunction with other available data, to identify oxygen imbalances in brain or other body tissue beneath the sensor and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care. The INVOS System is the clinical reference standard in cerebral/somatic oximetry, with an 11-year market track record, more than 600 clinical references and implementation at more than 700 U.S. hospitals. Somanetics also is developing a technology that integrates data from bedside devices into a single system for enhanced patient assessment and decision making, data management and data storage. Somanetics supports its customers through a direct U.S. sales force and clinical education team. Covidien markets INVOS System products in Europe, Canada, the Middle East and South Africa and Edwards Lifesciences represents INVOS System products in Japan. For more information visit www.somanetics.com.


'/>"/>
SOURCE Somanetics Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Somanetics Corporation to Release Third Quarter 2007 Financial Results and Host Conference Call September 19
2. Somanetics Corporation to Present at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
3. Somanetics Corporation to Release Fourth Quarter and Fiscal 2007 Financial Results and Host Conference Call January 23, 2008
4. Somanetics Corporation to Release First Quarter 2008 Financial Results and Host Conference Call March 18, 2008
5. Somanetics Reports Financial Results for the First Quarter of Fiscal 2008
6. Somanetics Announces Share Repurchase Program
7. Somanetics Announces Share Repurchase Program Increased by $15 Million
8. Somanetics Corporation to Present at Citigroup 2008 Healthcare Conference
9. Somanetics Receives 510(k) Clearance From the FDA to Expand INVOS System Labeling
10. Somanetics Announces Share Repurchase Program Increased By $15 Million
11. Somanetics Corporation to Present at Rodman & Renshaw Annual Global Investment Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced ... feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as a ... has released tools for healthy coping following a traumatic event. , Trauma sufferers tend ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... ... 24, 2016 , ... Strategic Capital Partners, LLC (SCP) in ... investment capital for emerging technology companies. SCP has delivered investment events and ... more than a million dollars of capital investment for five companies. ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... 26, 2016 Story Highlights: ... models within the health care industry is causing providers ... , Deloitte offers a suite of solutions for ... impacting efficient cost optimization: labor resource analysis, revenue cycle ... facilitate better outcomes and better economics ...
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
Breaking Medicine Technology: