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Sunridge International extends distribution contract with Beijing Vision World Trading

Sunridge International announced today that they have extended the exclusive distribution agreement with Beijing Vision World Trading Co., Ltd. for an additional 4 years.

6 Feb 2010

FDA's issues guidance on Bayesian statistical methods in medical device clinical trials

The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.

6 Feb 2010

Novus Scientific's TIGR Matrix Surgical Mesh receives FDA marketing approval

Novus Scientific Pte. Ltd today announced that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the TIGR™ Matrix Surgical Mesh, for use in reinforcement of soft tissues where weakness exists. TIGR™ Matrix Surgical Mesh is a 100 percent resorbable, synthetic matrix, knitted from two different resorbable fibers that degrade at different rates following implantation.

5 Feb 2010

Majority of rural hospital stays are covered by Medicare

Medicare patients accounted for almost half of all stays (45 percent) at rural hospitals in 2007, while the percentage of Medicare beneficiaries who were admitted to urban hospitals was considerably lower (35 percent) , according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

5 Feb 2010

Allergan acquires Serica Technologies

Morningside Technology Ventures, Prism VentureWorks, and Ivy Capital Partners are pleased to announce the acquisition of their portfolio company, Serica Technologies, Inc. by Allergan, Inc. Serica is a growth-stage medical device company focused on the development of biodegradable silk-based scaffolds for use in tissue regeneration in numerous therapeutic areas. Following the acquisition, Serica became a wholly owned subsidiary of Allergan.

4 Feb 2010

NovaBone Products relocates operations division to expanded and upgraded facilities

NovaBone Products, LLC has announced the relocation of its operations division to expanded and upgraded facilities where it will meet increasing demands of higher sales to a more geographically diverse distributor network.

4 Feb 2010

First annual Translational Regenerative Medicine Forum in Winston-Salem

The Regenerative Medicine Foundation today announced the first annual Translational Regenerative Medicine Forum to be held April 6-8, 2010 at the Benton Convention Center in Winston-Salem.

4 Feb 2010

Factory Reimbursement launches new research and reporting service for medical device companies

Factory Reimbursement announced today that it launched a new low-cost research and reporting service for medical device companies that wish to market and sell products in Europe.

4 Feb 2010

GTRI researchers design arthritis simulation gloves to meet the needs of consumers with functional limitations

As the U.S. population ages, manufacturers of consumer goods are realizing that many customers may not be as nimble-fingered or sharp-sighted as they once were.

4 Feb 2010

Cardiac Science announces global voluntary recall of certain AEDs

Cardiac Science Corporation is initiating a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The FDA has been informed of this situation.

4 Feb 2010

Home Diagnostics signs definitive merger agreement with Nipro

Home Diagnostics, Inc., a leading manufacturer and marketer of diabetes testing supplies, announced today that it signed a definitive merger agreement with Nipro Corporation (Tokyo Stock Exchange and Osaka Stock Exchange Ticker Code 8086), a global manufacturer and distributor of medical devices, pharmaceutical products and medical and glass products headquartered in Osaka, Japan, under which Nipro will acquire all outstanding shares of Home Diagnostics’ common stock, $.01 par value, for a cash purchase price of $11.50 per share (or aggregate consideration of approximately $215 million).

3 Feb 2010

Report: California biomedical industry faces unprecedented challenges

The biomedical industry is one of the most recession-resilient sectors in California's hard-hit economy and a critical driver of innovation, job growth and revenue that will help lead the state to economic recovery, according to a report released today by the California Healthcare Institute (CHI) and PricewaterhouseCoopers LLP (PwC).

3 Feb 2010

Pall launches Leukotrap Affinity Plus Prion and Leukocyte Reduction Filter System

Pall Corporation, a global leader in filtration, separation and purification, today announced the launch of the Leukotrap® Affinity Plus Prion and Leukocyte Reduction Filter System. The new blood filter reduces prions and leukocytes in a single step.

From Pall Corporation 3 Feb 2010

AtriCure announces definitive agreement with DOJ regarding surgical ablation devices

AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems, today announced that it has executed a definitive agreement with the Department of Justice (DOJ) and the Office of Inspector General of the Department of Health and Human Services to resolve the issues raised in the DOJ’s investigation and the related qui tam complaint regarding the marketing of the Company’s surgical ablation devices.

3 Feb 2010

Artefill could be viable for lipoatrophy and non-surgical anti-aging enhancement

Suneva Medical, a privately-held aesthetic medical device company, today announced that two clinical studies suggest Artefill may be a safe, effective, long-term treatment option for age-related and HIV lipoatrophy patients.

3 Feb 2010

First annual Translational Regenerative Medicine Forum to be held in Winston-Salem

The Regenerative Medicine Foundation today announced the first annual Translational Regenerative Medicine Forum to be held April 6-8, 2010 at the Benton Convention Center in Winston-Salem.

2 Feb 2010

Some sectors of health care industry are booming

The Sacramento Bee: "The gleaming new tower at Mercy San Juan Medical Center bustles with patients, nurses and doctors. ... Opened a month ago, Mercy's tower was cited in a recent report ranking Sacramento as the nation's fastest growing market for health care jobs. The six-story project added 110 beds and nearly 200 new jobs to the hospital. ... Already, the health care sector accounts for a fifth of the region's payroll." That could be poised to grow: "Aging baby boomers, coupled with the region's population growth, virtually guarantee that the demand for health services won't diminish" (Caina Calvan, 2/1).

2 Feb 2010

Australian TGA approves IDSI's CT Laser Mammography system for inclusion on ARTG

Imaging Diagnostic Systems, Inc., a pioneer in laser optical breast imaging, announced today that the Australian Government Department of Health and Ageing Therapeutic Goods Administration has approved the CT Laser Mammography (CTLM®) system for inclusion on the Australian Register of Therapeutic Goods (ARTG).

2 Feb 2010

ISO renewal audit for KIKA Clinical Solutions' U.S. and France operations complete

KIKA™ Clinical Solutions announced the successful completion of its ISO renewal audit for its operations in the U.S. and France. KIKA is the leading provider of advanced EDC solutions for Clinical Asset Management™ for the pharmaceutical, biotechnology and medical device markets.

1 Feb 2010

U.S. Marshals seize unapproved ozone generators from Applied Ozone Systems

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 79 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.

30 Jan 2010

Medical Devices News and Research

Sunridge International extends distribution contract with Beijing Vision World Trading

FDA's issues guidance on Bayesian statistical methods in medical device clinical trials

Novus Scientific's TIGR Matrix Surgical Mesh receives FDA marketing approval

Majority of rural hospital stays are covered by Medicare

Allergan acquires Serica Technologies

NovaBone Products relocates operations division to expanded and upgraded facilities

First annual Translational Regenerative Medicine Forum in Winston-Salem

Factory Reimbursement launches new research and reporting service for medical device companies

GTRI researchers design arthritis simulation gloves to meet the needs of consumers with functional limitations

Cardiac Science announces global voluntary recall of certain AEDs

Home Diagnostics signs definitive merger agreement with Nipro

Report: California biomedical industry faces unprecedented challenges

Pall launches Leukotrap Affinity Plus Prion and Leukocyte Reduction Filter System

AtriCure announces definitive agreement with DOJ regarding surgical ablation devices

Artefill could be viable for lipoatrophy and non-surgical anti-aging enhancement

First annual Translational Regenerative Medicine Forum to be held in Winston-Salem

Some sectors of health care industry are booming

Australian TGA approves IDSI's CT Laser Mammography system for inclusion on ARTG

ISO renewal audit for KIKA Clinical Solutions' U.S. and France operations complete

U.S. Marshals seize unapproved ozone generators from Applied Ozone Systems

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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