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VIDA Diagnostics Launches Apollo Pulmonary Analysis Software for Major Lung Disease at American Thoracic Society Meeting

May 16, 2011 11:35 am | by Bio-Medicine.Org | News | Comments

DENVER, May 16, 2011 /- VIDA Diagnostics, a leading developer of quantitative pulmonary imaging software, announced today the launch of its new Apollo™ Software for the evaluation of pulmonary disease including chronic obstructive pulmonary disease (COPD), asthma, and lung cancer,...

Long-term Safety and Effectiveness of Bronchial Thermoplasty Demonstrated in Treating Severe Asthma

May 16, 2011 9:32 am | by Boston Scientific | News | Comments

Five-year data from RISA Trial presented at ATS adds to clinical evidence showing long-term safety of Boston Scientific's Alair® Bronchial Thermoplasty System

FDA News & Notes - Week of May 16, 2011

May 16, 2011 9:32 am | by Bio-Medicine.Org | News | Comments

SILVER SPRING, Md., May 16, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights for this week from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as...

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Augmenix sells minority stake to Varian Medical for $15M

May 16, 2011 8:36 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Waltham biotech Augmenix Inc. has inked a deal with California med tech giant Varian Medical Systems Inc. in which Varian will pay $15 million for a minority stake in Augmenix.

Dune Medical's breast cancer device moves closer to market

May 16, 2011 8:36 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Dune Medical Devices Inc. says it has won an expedited review from the U.S. Food and Drug Administration (FDA) for its experimental device designed to improve the accuracy of breast cancer tumor removal surgery.

BridgePoint Medical Announced 510(k) Clearance for an Expanded Indication to Treat Coronary Chronic Total Occlusions

May 16, 2011 8:35 am | by Bio-Medicine.Org | News | Comments

MINNEAPOLIS, May 16, 2011 /- BridgePoint Medical, Inc., a Minnesota-based medical device company, has announced that they have received clearance of an expanded indication for the CrossBoss™ Catheter and Stingray™ System from the FDA.  The expanded indication includes the...

Abaxis Receives Presidential "E" Award for Exports

May 16, 2011 8:34 am | by Bio-Medicine.Org | News | Comments

UNION CITY, Calif., May 16, 2011 /- Abaxis, Inc. (NasdaqGS: ABAX), a medical products company manufacturing point-of-care blood analysis systems, today announced the Company was awarded the Presidential "E" Award for Exports by U.S. Department of Commerce Secretary Gary Locke at the...

Perrigo Announces FDA Final Approval for Ranitidine 150 - Generic Equivalent to Zantac 150®

May 16, 2011 8:33 am | by Bio-Medicine.Org | News | Comments

ALLEGAN, Mich., May 16, 2011 /- Perrigo Company (Nasdaq: PRGO ; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter (OTC) Ranitidine 150 (regular and cool mint), a generic...

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Watson Launches Generic AMRIX®

May 16, 2011 6:35 am | by Bio-Medicine.Org | News | Comments

PARSIPPANY, N.J., May 16, 2011 /- Watson Pharmaceuticals, Inc. (NYSE: WPI ) today confirmed that its subsidiary, Watson Pharma, Inc., has launched an authorized generic version of AMRIX® (Cyclobenzaprine Hydrochloride Extended-Release Capsules) 15 mg and 30 mg, as part of an...

New Mexico Software Announces 2011 First Quarter Financial Results

May 16, 2011 6:35 am | by Bio-Medicine.Org | News | Comments

ALBUQUERQUE, N.M., May 16, 2011 /- New Mexico Software, Inc. (OTCBB: NMXC) announced today the company's financial results for the first quarter of 2011. Revenue for the first quarter ended March 31, 2011 was $936,000, an increase of 4% compared to $903,000 reported in the same quarter a...

BAETA Corp Initiates Clinical Trial at NYU School of Medicine to Measure Efficacy of Pain Recording Device

May 16, 2011 5:37 am | by Bio-Medicine.Org | News | Comments

FORT LEE, N.J., May 16, 2011 /- BAETA Corp. (OTCBB: BAEA) announced today that the NYU School of Medicine will conduct a clinical trial to measure the efficacy of the Company's "MyHealthTrends for Pain" handheld device during intra-operative, pre- and post-surgical periods. This trial...

Accuray Showcases CyberKnife Robotic Radiosurgery System at American Urological Association Meeting

May 16, 2011 5:37 am | by Bio-Medicine.Org | News | Comments

SUNNYVALE, Calif. and WASHINGTON, May 16, 2011 /- The American Urological Association (AUA) Meeting, May 16, 2011 -- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, announced today that it will showcase the CyberKnife® Robotic Radiosurgery System ,...

AlphaDetail AlphaPulseâ„¢: Anticipated Impact of CATT Trial in Wet AMD Treatment

May 16, 2011 5:35 am | by Bio-Medicine.Org | News | Comments

SAN MATEO, Calif., May 16, 2011 /- On April 28, 2011 the New England Journal of Medicine released highly anticipated one-year results of the ongoing "Comparisons of Age-Related Macular Degeneration Treatments Trials" (CATT). AlphaDetail, Inc., a leader in global ophthalmology primary...

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Lilly USA, LLC Launches TruAssist for Patients

May 16, 2011 5:34 am | by Bio-Medicine.Org | News | Comments

INDIANAPOLIS, May 16, 2011 /- Lilly USA has launched www.LillyTruAssist.com and 1-855-LLYTRUE (1-855-559-8783), a website and call center for health care providers and patients to access information about Lilly's patient assistance programs, which help connect patients with the Lilly...

Lilly Oncology to Unveil Data From More Than 30 Studies at ASCO

May 16, 2011 5:34 am | by Bio-Medicine.Org | News | Comments

INDIANAPOLIS, May 16, 2011 /- Eli Lilly and Company (NYSE: LLY ) will present data from more than 30 studies at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill., from June 3 – 7, 2011, including results from PARAMOUNT, a Phase III study of...

Arstasis Launches New AXERAâ„¢ Access Device in the U.S.

May 16, 2011 5:33 am | by Bio-Medicine.Org | News | Comments

REDWOOD CITY, Calif., May 16, 2011 /- Arstasis is pleased to announce the U.S. launch of its latest commercial product - the AXERA™ Access Device.  The AXERA Device enhances insertability into the femoral artery and overall procedural usage while continuing to deliver the...

diaDexus, Inc. Reports 2011 First Quarter Financial Results

May 16, 2011 5:32 am | by Bio-Medicine.Org | News | Comments

SOUTH SAN FRANCISCO, Calif., May 16, 2011 /- diaDexus, Inc. (OTC Bulletin Board: DDXS ), a diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, today announced financial...

HYCOR Expands Board of Directors to Support Growth in Key Areas

May 16, 2011 5:32 am | by Bio-Medicine.Org | News | Comments

GARDEN GROVE, Calif., May 16, 2011 /- HYCOR Biomedical, Inc., a leading manufacturer and marketer of in vitro diagnostic products for the global allergy, autoimmune and urinalysis markets, together with owner Linden, LLC, today announced the appointments of Vijay Aggarwal, Ph.D. and James...

Siemens Showcases New Innovations in Clinical Diagnostics, Automation, and IT at IFCC-WorldLab Berlin 2011

May 16, 2011 5:32 am | by Bio-Medicine.Org | News | Comments

BERLIN, May 16, 2011 /- Siemens Healthcare Diagnostics is showcasing a broad spectrum of its clinical diagnostics portfolio, including a focus on scalable l ab automation solutions, at the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) WorldLab 2011 in...

Volcano to Highlight its Precision Guided Therapy Technologies at EuroPCR

May 16, 2011 2:33 am | by Bio-Medicine.Org | News | Comments

SAN DIEGO, May 16, 2011 /- Volcano Corporation (NASDAQ: VOLC ) today announced its participation in the Paris course for Revascularization (EuroPCR) from May 17 – 20. Volcano's focus will be on highlighting the strength of its product portfolio, which includes innovative devices...

Reportlinker Adds North America Hospital Supplies Market Outlook to 2017

May 16, 2011 1:34 am | by Bio-Medicine.Org | News | Comments

NEW YORK, May 16, 2011 /- Reportlinker.com announces that a new market research report is available in its catalogue: North America Hospital Supplies Market Outlook to 2017...

Sensing Brain Pressure without Surgery

May 15, 2011 8:32 pm | by Massachusetts Institute of Technology | News | Comments

A noninvasive technique could monitor concussions, migraines, and other conditions.

Simpler Genome Sequencing

May 13, 2011 2:35 pm | by Massachusetts Institute of Technology | News | Comments

A startup hopes to make the technology cheap enough that it's feasible for a typical hospital lab.

Zevex Warning Letter Cites CAPA, Software Issues

May 13, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Zevex International has received an FDA warning letter citing problems with its corrective and preventive action (CAPA) procedures and software fixes.

Panel Backs Bone Graft Device Despite FDA Concerns

May 13, 2011 1:30 pm | by U.S. Food & Drug Administration | News | Comments

An FDA advisory panel has backed BioMimetic Therapeutics’ investigational bone graft device, which uses a growth factor protein to regrow bones in the foot and ankle, despite FDA questions about the intended patient population.

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