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Sucampo submits marketing application for Amitiza drug

Sucampo Pharmaceuticals, Inc. and Abbott today announced that Sucampo Pharma Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc., has submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza (lubiprostone) 24 mcg for the treatment of chronic idiopathic constipation (CIC).

7 Oct 2010

Medical device industry, advocates weigh in on proposed expedited approval process

The Hill's Healthwatch blog reports that consumer groups and device makers are weighing in on a proposal to expedite the approval process for some medical devices.

7 Oct 2010

DiFUSION Technologies' Xiphos line of posterior interbody devices receive 510(k) clearance

DiFUSION Technologies Inc., a medical device company focused on the development and commercialization of its proprietary CleanFUZE anti-microbial technology for orthopedic implants, announced today the 510(k) clearance of its new Xiphos line of posterior interbody devices indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.

7 Oct 2010

FDA awards cooperative agreement to PAHO to develop information hub for medical products

The U.S. Food and Drug Administration today announced the award of a $904,000 cooperative agreement to the Pan American Health Organization (PAHO) to research and develop an information hub for medical products and related regulatory processes and systems in the Americas Region.

7 Oct 2010

Pioneer Surgical receives patent for nanOss technology

Pioneer Surgical Technology, Inc., a global medical device provider in orthopaedics, spine, and biologics, is proud to announce the United States Patent Office has reissued a patent further strengthening Pioneer's market position in nanocrystalline derived products used in orthopaedics.

6 Oct 2010

Synergetics anticipates $13 million net sales for fourth quarter 2010

Synergetics USA, Inc., a medical device company that designs, manufactures, and markets innovative microsurgical instruments for ophthalmic and neurosurgical applications, today announced that it expects to report net sales of approximately $13 million and net income of approximately $1 million for its fourth quarter ended July 31, 2010.

6 Oct 2010

Fisher Wallace Laboratories launches easy-to-use medical device for depression treatment

Fisher Wallace Laboratories today announced the launch of a bold YouTube video campaign that challenges the pharmaceutical drug industry and introduces the company's easy-to-use medical device prescribed for the self-treatment of depression: the Fisher Wallace Cranial Stimulator.

6 Oct 2010

Urovalve reports promising early results from Surinate Bladder Management System multi-site clinical study

Urovalve, a medical device company focused on creating superior products for urinary flow and control, reported today that early results are promising in a multi-site clinical study of the Company's Surinate® Bladder Management System. The Surinate® Bladder Management System is designed to improve the quality of life and health of men who suffer from acute or chronic urinary retention, an inability to empty the bladder.

6 Oct 2010

CTTC, Spero enter sales agreement for Calmare medical devices

Competitive Technologies, Inc. announced today that it has entered into a sales agreement with Spero Pain Relief Therapy, LLC. Spero, based in St. George, UT, opened its first of 14 planned pain clinics using CTTC's Calmare Pain Therapy medical device last month.

6 Oct 2010

Reuters, Milwaukee Journal Sentinel honored with Barlett & Steele Awards

Reuters received the gold award and the Milwaukee Journal Sentinel the silver award in the fourth annual Barlett & Steele Awards for Investigative Business Journalism, the Donald W. Reynolds National Center for Business Journalism announced today.

5 Oct 2010

Covidien to showcase innovative surgical products at 96th ACS Clinical Congress

Covidien, a leading global provider of healthcare products, will preview new devices and showcase some of the Company's most innovative products at the 96th Annual Clinical Congress of the American College of Surgeons.

5 Oct 2010

Calif. Governor signs law for oversight of CT scans; Ariz. man's transplant on hold because of Medicaid cuts; Texas pharmacies sue CVS Caremark

California Gov. Arnold Schwarzenegger has signed tough new legislation tightening oversight of diagnostic CT scans, largely in response to the overdosing of hundreds of patients who underwent brain scans for stroke in 2008 and 2009.

5 Oct 2010

CHI submits comments to FDA CDRH 510(k) Working Group Preliminary Report and Recommendations

California Healthcare Institute today submitted formal comments to the U.S. Food and Drug Administration (FDA) regarding the Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, which could transform the 510(k) regulatory process for new medical devices, greatly affecting innovation and public health in California. CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.

5 Oct 2010

GlobalNet Services awarded $14M contract to support FDA Unified Registration and Listing System

GlobalNet Services, Inc., a premier information technology provider for businesses and the Federal government, today announced that it had been awarded a $14 million contract to support the U.S. Food and Drug Administration's (FDA) Unified Registration and Listing System (FURLS). This five-year contract, which includes one base year and four option years, supports federal initiatives that require all facilities, which manufacture, process or hold FDA-regulated products to be registered with the Agency.

4 Oct 2010

FDA approves NovaBone Putty MIS Delivery System for orthopedic surgery

NovaBone Products, a medical device company, today announces the U.S. Food and Drug Administration's (FDA) approval of the NovaBone Putty® MIS Delivery System designed for use in minimally invasive orthopedic procedures.

4 Oct 2010

Maven Semantic updates Urinary Incontinence research database

Maven Semantic announces updates to their Urinary Incontinence research database.

4 Oct 2010

Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

Isotechnika Pharma Inc. announces that the results of the CONFIRM1 clinical trial conducted by its medical device partner, Atrium Medical Corporation, were presented by Glenn Van Langenhove, MD, PhD (Middelheim Hospital in Antwerp, Belgium), the principal investigator, at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 Scientific Symposium in Washington, DC last week.

3 Oct 2010

EXFO announces sale of Life Sciences and Industrial Division to The Riverside Company

EXFO Inc. announced today that it has sold its Life Sciences and Industrial Division to The Riverside Company, a global private equity firm, for US$24.3 million in cash. The purchase price is subject to adjustments for minimum working capital requirements.

1 Oct 2010

HHS announces $473 million grant to help people make effective healthcare decisions

HHS' Agency for Healthcare Research and Quality today announced the award of $473 million in grants and contracts to support projects that will help people make health care decisions based on the best evidence of effectiveness. The funding announced today covers all of AHRQ's allocation and $173 million administered for the HHS Secretary by AHRQ.

1 Oct 2010

Health Canada approves Meridian Bioscience's illumigene C. difficile molecular amplification assay

Meridian Bioscience, Inc., today announced that it has received an approved medical device license from Health Canada for its new molecular amplification assay, illumigene C. difficile. Clostridium difficile is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.

1 Oct 2010

Medical Devices News and Research

Sucampo submits marketing application for Amitiza drug

Medical device industry, advocates weigh in on proposed expedited approval process

DiFUSION Technologies' Xiphos line of posterior interbody devices receive 510(k) clearance

FDA awards cooperative agreement to PAHO to develop information hub for medical products

Pioneer Surgical receives patent for nanOss technology

Synergetics anticipates $13 million net sales for fourth quarter 2010

Fisher Wallace Laboratories launches easy-to-use medical device for depression treatment

Urovalve reports promising early results from Surinate Bladder Management System multi-site clinical study

CTTC, Spero enter sales agreement for Calmare medical devices

Reuters, Milwaukee Journal Sentinel honored with Barlett & Steele Awards

Covidien to showcase innovative surgical products at 96th ACS Clinical Congress

Calif. Governor signs law for oversight of CT scans; Ariz. man's transplant on hold because of Medicaid cuts; Texas pharmacies sue CVS Caremark

CHI submits comments to FDA CDRH 510(k) Working Group Preliminary Report and Recommendations

GlobalNet Services awarded $14M contract to support FDA Unified Registration and Listing System

FDA approves NovaBone Putty MIS Delivery System for orthopedic surgery

Maven Semantic updates Urinary Incontinence research database

Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

EXFO announces sale of Life Sciences and Industrial Division to The Riverside Company

HHS announces $473 million grant to help people make effective healthcare decisions

Health Canada approves Meridian Bioscience's illumigene C. difficile molecular amplification assay

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