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PMAs for Silicone Implants Should Be Revoked, Consumers Tell FDA Panel

September 2, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

PMAs for silicone gel-filled breast implants should be revoked if manufacturers don’t improve post-approval study follow-up, consumer advocates and a former FDA official told an agency advisory panel.

User Fee Talks Near the Wire As FDA, Industry Butt Heads

September 2, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Devicemakers and the FDA remain divided on the terms of Medical Device User Fee and Modernization Act (MDUFMA) reauthorization as the deadline approaches for resolving differences.

Are Radiologists Trustworthy?

September 2, 2011 12:39 pm | by Diagnostic Imaging | News | Comments

As a radiologist (or, indeed, any kind of physician), you are a professional. You have completed at least two decades of education, including an advanced degree. You have not just passed but scored very competitively on numerous exams, held up under scrutiny from dozens of educators and...

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Concussion Apps for Coaches and Parents: Will They Affect You?

September 2, 2011 12:38 pm | by Diagnostic Imaging | News | Comments

If you opened a patient's file before ordering or reading a CT or MRI scan and saw a note from a sideline coach saying the patient exhibited all the signs and symptoms of a concussion, what would you think? Would you be surprised?

Hurricane Irene Spurs Emergency Home Medical Services for Patients

September 2, 2011 9:34 am | by Bio-Medicine.Org | News | Comments

WASHINGTON, Sept. 2, 2011 /PRNewswire-USNewswire/ -- From the Carolinas to New England, many providers of durable medical equipment and services spent the past week preparing their customers for and responding to the havoc created by Hurricane Irene.  Of particular concern to...

Vycor Medical, Inc. Files Restated Financial Statements

September 2, 2011 7:36 am | by Bio-Medicine.Org | News | Comments

BOCA RATON, Fla., Sept. 2, 2011 /- On September 2, 2011, Vycor Medical, Inc. (the "Company") filed the following amended Annual Reports and Quarterly Reports with the Securities and Exchange Commission for the following periods: Form 10-K (1st Amendment) for the fiscal year ended...

CDRH Learn (Spanish): Overview of Regulatory Requirements: Medical Devices - Video, slides, transcript

September 2, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Online training though video presentation, slide presentation on medical device regulatory requirements

Molecular Devices Releases Breakthrough TUNE Technology, Now Part of the SpectraMax® Paradigm® Multi-Mode Microplate Detection Platform

September 2, 2011 4:38 am | by Bio-Medicine.Org | News | Comments

SUNNYVALE, Calif., Sept. 2, 2011 /- Today, Molecular Devices, a leading provider of instruments, software, and consumables for drug discovery and life sciences research, announced the addition of the TUNE detection cartridge to the SpectraMax Paradigm Multi-Mode Microplate Detection...

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Valeant Pharmaceuticals to Present at Industry Conferences

September 2, 2011 4:35 am | by Bio-Medicine.Org | News | Comments

MISSISSAUGA, Ontario, Sept. 2, 2011 /- Valeant Pharmaceuticals International, Inc. (NYSE: VRX ) (TSX: VRX) today announced that certain members of its senior management team will be participating at the following conferences: J. Michael Pearson, Chairman and Chief Executive Officer...

Prostate Cancer Awareness Month Starts in September

September 2, 2011 4:34 am | by Bio-Medicine.Org | News | Comments

CORAL SPRINGS, Fla., Sept. 2, 2011 /- What do Robert DeNiro, Hugo Chavez, Rudy Giuliani, Roger Moore, John Kerry, Don Imus, Harry Belafonte, Nelson Mandela, Colin Powell, Frank Zappa, Telly Savalas, Bill Bixby and Timothy Leary all have in common? If your answer is prostate cancer, then...

C8 MediSensors Launches c8medisensors.com

September 2, 2011 1:39 am | by RealWire | News | Comments

San José, California, September 2nd 2011 - C8 MediSensors, Inc., launched www.c8medisensors.com today, and the HG1-c, its new, noninvasive Continuous Glucose Monitor (nCGM).In its quest to make glucose measurement easy for individuals living with diabetes, C8 MediSensors developed...

Lifetime Products Enters New Product Category: Health and Wellness

September 2, 2011 12:38 am | by Bio-Medicine.Org | News | Comments

CLEARFIELD, Utah, Sept. 1, 2011 /- Lifetime Products, Inc. -- a worldwide Utah-based manufacturer of folding tables and chairs, sporting goods equipment, outdoor storage sheds, and lawn and garden products -- announced today that it is expanding its product depth and adding a new Health...

VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction

September 1, 2011 12:41 pm | by Bio-Medicine.Org | News | Comments

MOUNTAIN VIEW, Calif., Sept. 1, 2011 /- VIVUS, Inc. (NASDAQ: VVUS ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for its investigational drug candidate, avanafil, for the treatment of erectile...

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ConvaTec Announces Acquisition of Boston Medical Device

September 1, 2011 12:41 pm | by Bio-Medicine.Org | News | Comments

SKILLMAN, N.J., Sept. 1, 2011 /- ConvaTec Inc., a world-leading developer and marketer of innovative medical technologies for community and hospital care today announced that the company has acquired Boston Medical Device, Inc. (BMD), a distribution company that offers a platform of...

Angeion Corporation Reports Third Quarter Fiscal 2011 Operating Results

September 1, 2011 12:41 pm | by Bio-Medicine.Org | News | Comments

SAINT PAUL, Minn., Sept. 1, 2011 /- Angeion Corporation (NASDAQ: ANGN ) today reported financial results for its fiscal third quarter ended July 31, 2011. Angeion reported revenues of $6.8 million compared to $7.1 million in the third quarter of fiscal 2010. Angeion incurred a net...

Meaningful Use Can be Meaningful for Radiologists, Too

September 1, 2011 12:41 pm | by Diagnostic Imaging | News | Comments

With an estimated $1.5 billion in potential bonus payments at stake, radiologists should study and respond to recent federal regulations related to meaningful use of complete certified ambulatory electronic health records and their equivalents, say authors of a study in the September...

Pointing Out Added Value to Protect Radiologist Turf

September 1, 2011 12:41 pm | by Diagnostic Imaging | News | Comments

Radiologist groups shouldn't be shy about making clear their value to hospitals, according to an article published online today in the Journal of the American College of Radiology.

Hill-Rom to Participate in the Morgan Stanley Global Healthcare Conference

September 1, 2011 12:41 pm | by Bio-Medicine.Org | News | Comments

BATESVILLE, Ind., Sept. 1, 2011 /- Hill-Rom Holdings, Inc., (NYSE: HRC ) invites you to listen to a management presentation at the Morgan Stanley Global Healthcare Conference in New York City on September 14, 2011, at 8:35 a.m. ET. You are invited to listen to the live discussion via...

Kimberly-Clark Health Care Announces Selling Price Increase

September 1, 2011 12:37 pm | by Bio-Medicine.Org | News | Comments

ROSWELL, Ga., Sept. 1, 2011 /- Kimberly-Clark Health Care (KCHC) announced today that it is implementing a double-digit price increase on synthetic exam gloves due to unprecedented demand for and rising costs of raw materials, particularly butadiene and acrylonitrile.   "Despite...

New Drug Approved for Treatment of Non Small Cell Lung Cancer in Specific Patient Population

September 1, 2011 12:36 pm | by Bio-Medicine.Org | News | Comments

WASHINGTON, Sept. 1, 2011 /PRNewswire-USNewswire/ -- Lung Cancer Alliance (LCA) applauds the Food and Drug Administration (FDA) approval of Xalkori (crizotinib) with non-small cell lung cancer (NSCLC) who are ALK positive.  The drug was approved based on data from two clinical...

Roche Diabetes Care Celebrates Second Annual Infusion Site Awareness Week, Aug. 29-Sept. 4

September 1, 2011 12:34 pm | by Bio-Medicine.Org | News | Comments

INDIANAPOLIS, Sept. 1, 2011 /- Roche Diabetes Care, makers of the ACCU-CHEK® portfolio of diabetes management products and services, is proud to host its second annual Infusion Site Awareness Week, Aug. 29-Sept. 4, a week-long effort to highlight the importance of proper infusion...

Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment

September 1, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

Reclast should not be used in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.

Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions

September 1, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Reports of hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash.

Osseon® Announces Commercial Release of Osseoflex®SN (Steerable Needle)

September 1, 2011 10:38 am | by Bio-Medicine.Org | News | Comments

SANTA ROSA, Calif., Sept. 1, 2011 /- Today, Osseon® Therapeutics, Inc. launched the Osseoflex®SN (steerable needle). Osseoflex SN is the newest in Osseon's suite of minimally invasive products for treatment of spinal compression fractures. (Photo:  ...

Neurocrine Biosciences To Present at the Stifel Nicolaus 2011 Healthcare Conference

September 1, 2011 9:36 am | by Bio-Medicine.Org | News | Comments

SAN DIEGO, Sept. 1, 2011 /- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Stifel Nicolaus 2011 Healthcare Conference in Boston.   The live presentation...

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