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iMedConsent™ Application Achieves ONC-ATCB 2011/2012 EHR Certification from ICSA Labs

February 14, 2013 9:00 am | by The Associated Press | News | Comments

ATLANTA--(BUSINESS WIRE)--Feb 14, 2013--Dialog Medical, a subsidiary of Standard Register (NYSE:SR), reported today that its iMedConsent application has achieved 2011 Edition EHR Modular* Inpatient ONC-ACB Certification, which designates that the software is capable of supporting providers with...

FDA Clears Smiths Medical's At-Home Ambulatory Care Unit

February 14, 2013 8:59 am | by Mass Device | News | Comments

The FDA gives Smiths Medical the OK to launch its Cadd-Solis ambulatory care system in the U.S. St. Paul, Minn,-based device maker Smiths Medical got the green-light from the FDA for its newest ambulatory infusion system, which has been approved for at-home use. The Cadd-Solis VIP ambulatory infusion system integrates some of Smith Medical's other products, including its infusion pump, medication-level monitoring system and medication reservoirs


CryoLife 2012 Annual Revenues Grew to a Record $131.7 Million

February 14, 2013 8:04 am | by The Associated Press | News | Comments

Full Year Highlights: -- Total revenues grew 10% year-over-year to a record $131.7 million -- Product revenues grew 14% year-over-year to $67.5 million -- Tissue processing revenues grew 6% year-over-year to $63.6 million -- Generated $19.0 million in cash flow from operations Fourth...


Boston Scientific Amid Headquarters Shift

February 14, 2013 7:29 am | by Mass Device | News | Comments

Massachusetts medical device titan Boston Scientific (NYSE:BSX) will need to add 50 new employees for each 500 square-feet of new space at its new Marlborough headquarters, in compliance with the 2nd phase of a long-term tax incentive program agreed upon by the city. The company announced in November 2012 that it would move 13 miles of its previous headquarters in Natick, Mass.


Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers

February 14, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), requires FDA to establish and publish criteria to reaccredit and deny reaccreditation to third parties under section 523 of the FD&C Act (21 U.S.C. 360m) to perform premarket review of class I and eligible class II premarket notification [510(k)] submissions. 


Class I Medical Device Recall: GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems

February 14, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The oxygen and air wall inlet fittings and/or labels on the back panel of the resuscitation systems may have been reversed during assembly. As a result, this could potentially reverse the air/oxygen concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen and vice versa. The settings of the blender knob would no longer be accurate.


Sanofi to Enter Medical Device Market

February 13, 2013 7:50 pm | by I-Micronews | News | Comments

Since 2008, the company has spent $33 billion on partnerships and acquisitions. Chris Viehbacher, CEO of Sanofi, stated that he planned to replenish the company’s product pipeline. In addition, he wants to reduce the company’s reliance on a few high-value products that could be subject to generic competition in the future.ceutical company, is making a move into the medical device market.

Report: Healthcare hacks "likely to increase in frequency" in coming years

February 13, 2013 5:00 pm | by Mass Device | News | Comments

Malicious hackers are likely to target healthcare databases and patient medical records with increasing frequency in coming years, according to technology security auditing firm Redspin. Malicious hacking poses a grave threat to healthcare providers, and the likelihood of being targeted may be increasing in coming years, according to an audit by technology security firm Redspin.


Dynasil Corporation of America Reports First Quarter Fiscal 2013 Financial Results

February 13, 2013 4:10 pm | by The Associated Press | News | Comments

WATERTOWN, Mass.--(BUSINESS WIRE)--Feb 13, 2013--Dynasil Corporation of America (NASDAQ: DYSL), a leading developer of sensing, detection and analysis technology for homeland security, medical and industrial applications, today announced financial results for the fiscal 2013 first quarter ended...

Device makers respond to the State of the Union with renewed calls for device tax repeal

February 13, 2013 3:29 pm | by Mass Device | News | Comments

Medical device respond to President Barack Obama's State of the Union address, saying the call for strengthening the economy is incompatible with the medical device tax contained in the President's healthcare reform law. This word cloud represents the language in President Barack Obama's State of the Union address, with size representing frequency.

Invacare Ekes Out 2012 Profit, Despite 'Most Challenging Year'

February 13, 2013 3:25 pm | by Mass Device | News | Comments

Invacare manages a swing to 2012 black despite what CEO Gerald Blouch called 1 of "the most challenging" in the company's history. Invacare (NYSE:IVC) weathered what CEO Gerald Blouch called "1 of the most challenging in the company's history" and managed to eke out a small profit.

Tigre Becomes First Heart Safe City in Argentina by Implementing ZOLL AED Plus

February 13, 2013 2:59 pm | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 13, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that the city of Tigre in the Province of Buenos Aires, has installed ZOLL AED Plus ® units in public areas throughout this popular tourist...


Consistently Good Acute Stroke Outcomes and Device Safety With The Penumbra System™ Again Confirmed In NIH-Funded Study

February 13, 2013 1:41 pm | by The Associated Press | News | Comments

ALAMEDA, Calif.--(BUSINESS WIRE)--Feb 13, 2013--Last week Joseph Broderick, MD, Principle Investigator of the Interventional Management Of Stroke III (IMS III) Trial, announced the overall results and major subgroup analyses at the International Stroke Conference (ISC) in Honolulu, Hawaii.


Frost & Sullivan Acknowledges that PKC's Biosensors are Expected to Become the New Industry Standard in Pathogen Testing

February 13, 2013 12:21 pm | by Bio-Medicine.Org | News | Comments

MOUNTAIN VIEW, Calif. , Feb. 13, 2013 /- Based on its recent analysis of the global biosensors market, Frost & Sullivan recognizes Pharmaco-Kinesis Corporation (PKC) with the 2013 Global Frost & Sullivan Award for New Product Innovation. The company has set a new standard in the biosensors market with its innovative, highly sensitive biosensor. This unique, multi-pathogen...


Loma Vista Medical Reports That It is Ramping up Sales in U.S. and Europe of its FDA-Cleared and CE-Marked TRUE Dilatation™ Balloon Valvuloplasty Catheter Specifically Designed to Reduce ‘Rapid Pacing’ Time and Prevent Balloon Failure

February 13, 2013 9:34 am | by The Associated Press | News | Comments

BURLINGAME, Calif.--(BUSINESS WIRE)--Feb 13, 2013--Loma Vista Medical announced today that it has established a direct sales force in the United States and has scaled its partnerships with seven (7) distributors in Europe in order to keep pace with the rapidly increasing demand for its FDA-cleared and CE-marked...


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