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FDA Updates Guidance on Pulse Oximeter Applications

March 7, 2013 9:29 am | by Mass Device | News | Comments

The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, published March 4, the FDA specified new rules for identifying, testing and assuring safety for the systems.


First U.S. Installation of Centricity Cardio Enterprise Complete

March 7, 2013 9:09 am | by The Associated Press | News | Comments

SAN FRANCISCO--(BUSINESS WIRE)--Mar 7, 2013--GE Healthcare today announced the first U.S. installation of its Centricity™ Cardio Enterprise solution at Oklahoma State University Medical Center. This robust IT solution supports GE Healthcare’s enterprise imaging strategy by offering cardiologists a...


Former US Secretary of Health and Human Services and Wisconsin Governor Joins Tenex Health Board of Directors

March 7, 2013 9:00 am | by The Associated Press | News | Comments

LAKE FOREST, Calif.--(BUSINESS WIRE)--Mar 7, 2013--Tenex Health announces the appointment of Tommy G. Thompson to its Board of Directors. Tommy G. Thompson is a former United States Health and Human Services (HHS) Secretary and four-term Governor of Wisconsin. Following his term in public office,...


Study: Experimental Anorexia Treatment with Deep Brain Stimulation May Provide Lasting Results

March 7, 2013 8:59 am | by Mass Device | News | Comments

In what some are calling "a world 1st," researchers reported some success in treating severe anorexia patients via implanted electrodes that delivered electrical energy to the regions of the brain associated with emotion. The study enrolled 6 patients to receive the experimental treatment...


Philips Healthcare and Infraredx Introduce Solution to Enable Seamless Integration of TVC Imaging System with Philips’ Allura Xper Systems

March 7, 2013 8:30 am | by The Associated Press | News | Comments

ANDOVER, Mass. & BURLINGTON, Mass.--(BUSINESS WIRE)--Mar 7, 2013--Royal Philips Electronics (NYSE: PHG, AEX: PHI) and Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery and other vascular diseases, today announced the availability...


In Vitro Diagnostics Markets Grow at Double the Pace of Pharma Markets in Shift toward Globalization

March 7, 2013 8:04 am | by PR Newswire | News | Comments

Global in vitro diagnostics markets are a bright spot in the healthcare industry largely due to the increasing focus on global expansion. This is particularly seen in emerging markets that continue to gain steam as markets flatten. This briefing, featuring a live Q&A with the industry analyst, will explore the IVD market dynamics in these and other key regions globally.


Clinical Trial Results for Dune Medical Devices' MarginProbe@ System Presented at 66th Annual SSO Cancer Symposium

March 7, 2013 8:01 am | by The Associated Press | News | Comments

Dune Medical Devices, Inc., announced today that results from the pivotal clinical trial for the MarginProbe System, Dune's breakthrough intra-operative tissue assessment tool for early-stage breast cancer surgery, were presented at the 66th Annual Society of Surgical Oncology (SSO) Cancer ...


New U.S. Market Data Shows ICU Medical's Needlefree IV Connector Technology Chosen More than Twice as Often as Any Other

March 7, 2013 8:00 am | by PR Newswire | News | Comments

SAN CLEMENTE, Calif., March 7, 2013 /PRNewswire/ -- ICU Medical, Inc. (NASDAQ:ICUI) today announced that its family of needlefree intravenous (IV) connectors was chosen by U.S. healthcare providers more than twice as often as any other connector technology according to newly released...


Report: Diabetes Cost the U.S. $245B in 2012

March 7, 2013 7:29 am | by Mass Device | News | Comments

The cost of diabetes care has increased more than 40% in just 5 years, amounting to $245 billion last year. The growing cost reflects the rising number of patients suffering from the disease, according to a report from the American Diabetes Assn. More than $1 in every $10 spent on healthcare in the U.S. goes to diabetes and related complications...

MiMedx Announces 2012 Results

March 7, 2013 7:00 am | by PR Newswire | News | Comments

KENNESAW, Ga., March 7, 2013 /PRNewswire/ -- MiMedx Group, Inc.  (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today its results for the year ended...

'Disappearing Stent is a Dream Come True' - World Leaders at India Live Cardiology Conference 2013

March 7, 2013 6:13 am | by PR Newswire | News | Comments

For its ability to unblock and then make arteries return to natural form, the recently launched bioresorbable vascular scaffold (BVS and also known as disappearing stent) is being hailed as the 4th revolution in management of coronary artery disease at India's biggest conference on interventional cardiology.


CASMED Announces Fourth Quarter and Full-Year 2012 Financial Results

March 7, 2013 2:45 am | by GlobeNewswire | News | Comments

CAS Medical Systems, Inc., a leader in medical devices for non-invasive patient monitoring, today reported financial results for the three and 12 months ended December 31, 2012. Net sales were $6.0 million for the fourth quarter and $22.7 million for the year, compared with $5.3 million and $22.5 million in comparable prior-year periods, respectively.


Class I Medical Device Recall: Ad-Tech Medical Instrument Corporation, Macro Micro Subdural Electrodes

March 7, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

There is a concern the microelectrodes are defective and may cause injury to the brain. As a result, there is the potential for scraping (abrasion) of brain tissue and for broken pieces to remain in the brain tissue when the physician removes the...


CCS Medical Announces Agreement with LifeScan

March 6, 2013 7:39 pm | by PR Newswire | News | Comments

CCS Medical announced today that is has entered into an agreement with LifeScan, Inc., to provide diabetes testing supplies to patients across the country. "This agreement means that CCS Medical is a LifeScan Direct Mail Order Supplier with the ability to serve all Medicare beneficiaries and many commercial plan members who use LifeScan products...

Boston Scientific Updates PREVAIL Late Breaking Clinical Trials Presentation

March 6, 2013 4:34 pm | by PR Newswire | News | Comments

NATICK, Mass., March 6, 2013 /PRNewswire/ -- The Boston Scientific Corporation (NYSE: BSX) PREVAIL clinical trial results will be presented in a Late-Breaking Clinical Trial presentation at the 62nd Annual Scientific Sessions of the American College of Cardiology, and will include all...



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