Navigation Links
Somanetics Receives 510(k) Clearance From the FDA to Expand INVOS System Labeling
Date:5/27/2008

TROY, Mich., May 27 /PRNewswire-FirstCall/ -- Somanetics Corporation (Nasdaq: SMTS) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its INVOS Cerebral/Somatic Oximeter System.

"We believe this new 510(k) will serve to support our ongoing efforts in the pediatric and neonatal ICU market segments in several ways," said Bruce Barrett, Somanetics' president and CEO. "First, the 510(k) expands the indication for use to include monitoring tissues beneath the sensor, not limited to brain and skeletal muscle tissue. Second, it simplifies the indication for use language and clarifies that the technology is for use on any individual, described as neonates, infants, children and adults. It also incorporates changes we have made to the newest INVOS Model 5100C monitor."

"In addition, the 510(k) includes results from the Company's neonatal piglet trials," said Barrett. "In the smaller patients found in the neonatal ICU, in particular, the neonatal piglet data shows that placing the sensors over the abdomen and flank provides important information from the bowels and kidney, respectively. We can now discuss these applications with our customers in a meaningful way," he said.

About Somanetics

Somanetics Corporation (Nasdaq: SMTS) develops, manufactures and markets the INVOS(R) Cerebral/Somatic Oximeter System, a non-invasive patient monitoring system that continuously measures changes in the blood oxygen levels in the brain and elsewhere in the body in patients with or at risk for restricted blood flow. Surgeons, anesthesiologists, intensive care nurses and other medical professionals can use the information provided by the INVOS System, in conjunction with other available information, to identify oxygen imbalances in tissues beneath the sensor and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care. 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 http://www.somanetics.com .


'/>"/>
SOURCE Somanetics Corporation
Copyright©2008 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. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
10. DaVita Receives Civil Complaint
11. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... , ... As health professionals work to improve their approach to healthcare, there ... more than filling out a survey; in many cases health professionals and patients are ... care and research on the importance of active engagement with patients and members of ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, ... guideline updates for the primary prevention of cardiovascular diseases during the 15th ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “The Journey: ... faced every danger possible to save lost souls in the Philippines. “The Journey: From ... Carole is a dedicated teacher of the Bible. She has taught all ages and ...
(Date:10/12/2017)... ... October 12, 2017 , ... The ... demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, ... to meet the highest standard. , These products are also: Gluten Free, ...
Breaking Medicine News(10 mins):
(Date:10/7/2017)... IRVING, Texas , Oct. 6, 2017   ... industry with more than $100 billion in purchasing power, ... industry news and information. The Newsroom is ... chain and industry trends, infographics, expert bios, news releases, ... Besides having access to a wealth of resources at ...
(Date:10/2/2017)... -- Diplomat Pharmacy, Inc. (NYSE: DPLO ) ... , and named its founder as Diplomat,s chief information ... Tennessee , will operate under Diplomat subsidiary Envoy ... for health care partners to include IT outsourcing, consulting, ... "In an interoperable world, technology delivers comprehensive insight and ...
(Date:9/28/2017)... , Sept. 28, 2017 Hill-Rom Holdings, ... 2017 earnings conference call and webcast on Friday, November ... a.m. (EDT) and ending at approximately 8:30 a.m. (CDT) ... discussing the company,s 2017 financial performance and guidance for ... opportunities, initiatives to enhance operational performance, and long-range financial ...
Breaking Medicine Technology: