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Guidance for Industry and FDA Staff - 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing...

April 14, 2011 7:36 am | by U.S. Food & Drug Administration | Comments

Section 515(d)(6)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) provides that PMA supplements are required for any change to a device subject to an approved application that affects safety or effectiveness, unless such change is a...

Dynatronics Regains Compliance With NASDAQ

April 14, 2011 7:36 am | by Bio-Medicine.Org | Comments

SALT LAKE CITY, April 14, 2011 /- Dynatronics Corporation (NASDAQ: DYNT ) today announced that the company has received a letter from NASDAQ stating that Dynatronics has regained compliance with the $1.00 minimum bid requirement for listing on that exchange. "By curing the $1 minimum bid...

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Sanare Launches BrightSky, a New Consumer Brand Serving People Living With Diabetes

April 14, 2011 7:36 am | by Bio-Medicine.Org | Comments

RENO, Nev., April 14, 2011 /- Sanare, LLC, a leading provider of care management solutions for people with diabetes, announced today the launch of its new consumer brand, BrightSky. (Logo: http://photos.prnewswire.com/prnh/20110414/FL83264LOGO) BrightSky is the backbone of Sanare's value...

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Spine Pain Management, Inc. Conference Call and Webcast Reminder and Instructions

April 14, 2011 7:35 am | by Bio-Medicine.Org | Comments

HOUSTON, April 14, 2011 /- Spine Pain Management, Inc., (OTC BB: SPIN) through its CEO, Dr. William Donovan would like to invite all Investors and interested parties to participate in the Company's first interactive phone and web-based conference call with PowerPoint presentation. During...

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ERT Awarded over $10 Million of ePRO Business from Major Pharma – Increasing its Position as a Leading ePRO Provider

April 14, 2011 7:33 am | by RealWire | Comments

PHILADELPHIA, PA - 14 April 2011 ERT, a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations, announced today that it was awarded three new contracts with top tier pharmaceutical companies, totaling over...

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Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

April 14, 2011 7:30 am | by U.S. Food & Drug Administration | Comments

FDA continues to receive reports of a rare cancer of white blood cells.

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Accuray Incorporated to Report Financial Results for Third Quarter of Fiscal 2011

April 14, 2011 6:38 am | by Bio-Medicine.Org | Comments

SUNNYVALE, Calif., April 14, 2011 /- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, today announced that it will report results for its third quarter of fiscal 2011, ended March 31, 2011 on Thursday, May 5, 2011 after the market closes. A conference...

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Merz Pharmaceuticals Joins Patient Advocates to Raise Awareness of Cervical Dystonia and Blepharospasm

April 14, 2011 6:37 am | by Bio-Medicine.Org | Comments

GREENSBORO, N.C., April 14, 2011 /- Merz Pharmaceuticals, LLC, maker of XEOMIN® (incobotulinumtoxinA), a botulinum toxin type A free from accessory proteins, today announced the launch of the "Make Your Mark" campaign. With the help of patient advocates, "Make Your Mark" celebrates...

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Varian Medical Systems to Exhibit the Latest Digital Image Detectors, X-Ray Tubes and Cancer Treatment Technologies at the CMEF Show in Shenzhen, China

April 14, 2011 6:37 am | by Bio-Medicine.Org | Comments

SALT LAKE CITY, April 14, 2011 /- Booth #H1/E32 -- Varian Medical Systems (NYSE: VAR ) will exhibit a wide selection of X-ray tubes and flat panel image detectors for digital radiography (DR) at the China International Medical Equipment Fair (CMEF) meeting in Shenzhen, China, April 16-18,...

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IDEV Announces Full Canadian Regulatory Approval for SUPERA VERITAS®

April 14, 2011 6:36 am | by Bio-Medicine.Org | Comments

WEBSTER, Texas, April 14, 2011 /- The Medical Devices Bureau of Health Canada has granted regulatory approval for the SUPERA VERITAS stent system for use in biliary and peripheral procedures.  IDEV's unique stent was previously available on a limited basis only, through the Special...

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Mpex Pharmaceuticals, Inc. to be Acquired by Axcan

April 14, 2011 6:36 am | by Bio-Medicine.Org | Comments

SAN DIEGO, April 14, 2011 /- Mpex Pharmaceuticals, Inc. announced today that Axcan and Mpex have entered into agreements pursuant to which Axcan will acquire all of the outstanding shares of Mpex and its lead product candidate, Aeroquin™.  A proprietary aerosol formulation of...

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MRI Safety: New Cardiac Pacemaker System Now Available in the U.S.

April 14, 2011 6:34 am | by Diagnostic Imaging | Comments

On February 8, 2011, a new cardiac pacemaker received approval from the FDA, which for the first time allows MRI procedures to be performed in patients by following specific labeling requirements. http://www.medtronic.com/mrisurescan. The “MR Conditional” Revo MRI SureScan Pacing System...

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Portable Ultrasound Market Grows as Machines Become Smaller, Better

April 14, 2011 6:34 am | by Diagnostic Imaging | Comments

The reach of portable or compact ultrasound is increasing, with the machines getting smaller, better and more adaptable. In fact, this segment of the market is outpacing the overall ultrasound market.

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Congress Must Maintain Commitment to Advanced Biofuels and Renewable Fuel Standard, BIO Says

April 14, 2011 5:34 am | by Biotechnology Industry Organization | Comments

WASHINGTON, D.C. (Wednesday, April 13, 2011) - The Renewable Fuel Standard provides the market and regulatory certainty necessary to drive private investment and maintain progress in research and development of advanced biofuels, the Biotechnology Industry Organization (BIO) said today in...

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Tooling U Releases Online Training Content for Composites

April 14, 2011 4:38 am | by Society of Manufacturing Engineers | Comments

CLEVELAND, Ohio, April 12, 2010 — To meet the needs of manufacturers who are increasingly using non-traditional materials in their manufacturing process, Tooling U announces a new web-based composites training program. More

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