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Paragonix Technologies, Inc., Announces Clearance of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

February 12, 2013 6:00 am | by The Associated Press | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 12, 2013--Paragonix Technologies, Inc. today announced that it has received clearance for its Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac Transport System 1 (CTS). The...

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Trovagene Announces Commercial Launch Timelines for HPV Carrier and Oncogene Mutation Tests

February 12, 2013 5:27 am | by Bio-Medicine.Org | News | Comments

SAN DIEGO , Feb. 12, 2013 /- Trovagene, Inc. (NASDAQ:  TROV) today announced that the development of its proprietary, urine-based HPV carrier screening test is progressing well and the Company expects to achieve analytical and clinical validation of the test in its CLIA laboratory in March 2013. When validation is completed, the test will be available to clinicians and...

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Market Research Report -- New Opportunities for Needle-Free Injection Market

February 12, 2013 4:09 am | by The Associated Press | News | Comments

MarketResearch.com has announced the addition of the market research report "The World Market for Injectable, Implantable and Needle-Free Drug Delivery Systems" to their product offering. All segments of the drug delivery arena are experiencing rapid evolution. This is particularly...

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Class I Medical Device Recall: St. Jude Medical, AMPLATZER TorqVue FX Delivery System

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

On January 17, 2013, St. Jude Medical sent an “Urgent Medical Device Recall Notice” to their customers. The letter advised customers to stop using the device and remove it from their inventory. St. Jude Medical plans to have their sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product.

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Palomar Medical Gains on Swing to Q4 Black

February 11, 2013 6:49 pm | by Mass Device | News | Comments

Fourth-quarter profitability sends shares of Palomar Medical up nearly 5% on Wall Street today. Palomar Medical (NSDQ:PMTI) gained on Wall Street today after a swing to 4th-quarter profits bested Wall Street's earnings expectations by 1 thin dime.

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ArthroCare to Host Conference Call on February 14, 2013

February 11, 2013 4:27 pm | by The Associated Press | News | Comments

AUSTIN, Texas--(BUSINESS WIRE)--Feb 11, 2013--ArthroCare Corporation (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, plans to release its fourth quarter and year end 2012 results on Thursday, February 14, 2013. ArthroCare will host a conference call...

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Weight Loss: EnteroMedics Shares Tank After Device "Fails" Study

February 11, 2013 2:42 pm | by Mass Device | News | Comments

Weight loss devices maker EnteroMedics loses half of its Wall Street value after its VBloc vagal blocking therapy system fails to meet endpoints in a pivotal trial. Wall Street fled in droves after weight-loss devices maker EnteroMedics (NSDQ:ETRM) announced that its Maestro vagal blocking system failed to meet endpoints in a pivotal study, but the mass exodus isn't discouraging the company from moving forward with a bid for FDA approval.

Data I/O Corporation to Display PS588 With Second Generation 3D Coplanarity Vision System at IPC APEX Expo

February 11, 2013 2:27 pm | by The Associated Press | News | Comments

Data I/O Corporation (NASDAQ: DAIO), the leading provider of manual and automated device programming solutions for electronics manufacturers, will display the PS588 with a second generation 3D coplanarity vision system at IPC APEX Expo February 19th - 21st, 2013 at the San Diego Convention...

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Over 19 Billion IVD Procedures Performed in 2012: Reports Kalorama

February 11, 2013 12:27 pm | by The Associated Press | News | Comments

In a sign that testing has become a significant part of clinical practice, Kalorama Information has noted that the total amount of in vitro diagnostic test procedures conducted globally reached 19.1 billion in 2012 and is expected to rise by 4.2% per year through 2017. The finding was made...

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Varian Medical Systems Supports Program to Tap Brain Power of Research and Development Community in Russia

February 11, 2013 11:01 am | by The Associated Press | News | Comments

Varian Medical Systems (NYSE: VAR), the world leader in radiotherapy and radiosurgery, is working with key development agencies in Russia to encourage the country's leading research institutes and scientists to collaborate on research and development proposals for programs aimed at advancing...

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Vitera Healthcare Solutions Welcomes Kermit Randa to Executive Team

February 11, 2013 10:00 am | by The Associated Press | News | Comments

TAMPA, Fla.--(BUSINESS WIRE)--Feb 11, 2013--Vitera Healthcare Solutions, the nation’s premier provider of ambulatory electronic health records and practice management solutions, announced today that Kermit Randa, FACHE, CPHIMS, will join the company’s leadership team as Executive Vice President,...

Precision Biopsy Appoints Amir Tehrani as Chief Executive Officer and Announces Successful Completion of Phase I Clinical Trial in Prostate Cancer Patients

February 11, 2013 9:00 am | by The Associated Press | News | Comments

DENVER, Colo.--(BUSINESS WIRE)--Feb 11, 2013--Precision Biopsy is pleased to announce that Amir Tehrani has joined as Chief Executive Officer to manage commercial expansion after the company successfully demonstrated the unique ability of its technology to accurately diagnose prostate cancer in...

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Award Winning Inventor Creates Revolutionary Gadget For Healthy Bowel Movements

February 11, 2013 8:55 am | by Bio-Medicine.Org | News | Comments

OJAI, Calif. , Feb. 11, 2013 /- According to the US Department of Health and Human Services, 63 million people in the US are chronically constipated, 75% of people over the age of 45 suffer from hemorrhoids and about $725 million dollars is spent on over the counter laxative products each year. R&D 100 award winning inventor, Reno Rolle has a healthy and affordable...

Michael Berman Joins InspireMD Board

February 11, 2013 8:01 am | by The Associated Press | News | Comments

InspireMD, Inc. ("InspireMD" or the "Company") (OTC: NSPRD) announced that Michael Berman joined its board of directors. Mr. Berman previously served as a Senior Vice President of Boston Scientific Corp., Group President of its cardiology businesses, and a member of the Executive Committee. ...

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Life Technologies Receives FDA 510(k) Clearance for Diagnostic Use of Sanger Sequencing Platform and HLA Typing Kits

February 11, 2013 8:01 am | by The Associated Press | News | Comments

Life Technologies Corporation (NASDAQ: LIFE) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore@ HLA typing kits. The development represents additional execution against the company's strategy to become a...

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