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FDA may drop medical device 'fast track' amid overuse concerns

The Food and Drug Administration may eliminate a program that allows medical devices to be approved quickly because of concerns the program is overused, The Wall Street Journal reports. An internal FDA memo proposes the elimination or tightening of the "fast track" as officials question the use of private, third-party companies "hired by device makers to pre-review products.

19 Feb 2010

IMS Health launches IMS Aggregate Spend Compliance Services

IMS Health, the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today announced the launch of IMS Aggregate Spend Compliance Services, a comprehensive set of solutions to help pharmaceutical and medical device companies comply with the growing number of federal and state transparency and marketing disclosure laws in the U.S., known as “aggregate spend” reporting regulations.

18 Feb 2010

Anulex Technologies announces the commercial availability of Xclose Plus Tissue Repair System

Anulex Technologies, Inc., a privately held medical device manufacturer focusing on spinal disc Preservation & Anular Repair™ products, announced the commercial availability of the Xclose™ Plus Tissue Repair System at the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves meeting in Orlando, Florida.

18 Feb 2010

CryoLife discloses financial results for fourth-quarter and full-year 2009

CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, announced today that revenues for the fourth quarter of 2009 increased 12 percent to a quarterly record of $28.6 million compared to $25.5 million for the fourth quarter of 2008. This was the 12th consecutive quarter of profitability for the Company.

18 Feb 2010

Medline Industries signs exclusive distribution agreement with Derma Sciences for BIOGUARD Barrier Dressings

Derma Sciences, Inc., a specialty medical device and pharmaceutical company focused on advanced wound care, today announced that it has signed an exclusive distribution agreement with Medline Industries for sales of one of its key products – BIOGUARD™ Barrier Dressing – into the acute care market. Medline is the 2nd leading provider of traditional wound care products into Acute Care facilities, with over 800 sales representatives. Sales will begin this month.

18 Feb 2010

West Pharmaceutical Services reports 19.9% growth in consolidated fourth-quarter sales

West Pharmaceutical Services, Inc. today announced its results for the fourth quarter and full year of 2009.

18 Feb 2010

AdvanSource Biomaterials reports 2.9% decrease in third-quarter revenue

AdvanSource Biomaterials Corporation, a leading developer of advanced polymer materials for a broad range of medical devices, today announced financial results for its fiscal 2010 third quarter ended December 31, 2009.

18 Feb 2010

Olympus launches new medical devices for LESS surgery

A variety of new medical devices specifically designed for Laparo-Endoscopic Single-Site surgery (LESS surgery) has been announced and introduced by Olympus Europa Holding GmbH and Olympus Medical Systems Corporation. LESS surgery is an advanced, minimally invasive operation technique by which an endoscope and hand instruments are inserted through an access port anchored in just one small incision, usually made in the navel. After developing all the medical devices needed to perform LESS surgery, Olympus has yet again proven its leadership in the field. The release of these innovative devices in Europe took place in autumn 2009.

From Evident Corporation - Life Sciences 18 Feb 2010

Ardiem Medical receives non-exclusive license to make and sell neuromodulation devices

Ardiem Medical Inc. has obtained a non-exclusive license to make and sell neuromodulation devices based on intellectual property developed at Case Western Reserve University's Department of Biomedical Engineering and the Functional Electrical Stimulation Center in Cleveland.

17 Feb 2010

IH Systems selects Robotic IV Automation Systems for cytotoxic drug preparation

Following the successful integration of RIVA (Robotic IV Automation System) - a self-contained unit for filling IV syringes and bags - into three healthcare institutions in 2009, and the announcements of several more sales for installation in 2010, medical device company Intelligent Hospital Systems has confirmed the sale of three additional RIVA systems for cytotoxic drug preparation in 2010.

17 Feb 2010

Derma Sciences announces pricing of public offering of 972,000 shares of its common stock

Derma Sciences, Inc., a specialty medical device and pharmaceutical company focused on advanced wound care, today announced the pricing of a public offering of 972,000 shares of DSCI common stock and 324,000 warrants to purchase shares of common stock at a price of $5.50.

17 Feb 2010

Beating animal heart created: University of Minnesota signs global license agreement with Miromatrix Medical

A major step in commercializing the groundbreaking research of Dr. Doris Taylor was achieved recently when the University of Minnesota signed an exclusive, global license agreement with Miromatrix Medical Inc. Dr. Taylor's research garnered worldwide attention in 2008 when her team announced that it had created a beating animal heart in her laboratory.

17 Feb 2010

ICAP Ocean Tomo offers Medcanica's patent portfolio for sale

ICAP Ocean Tomo, the intellectual property brokerage division of ICAP plc (IAP.L), is offering for sale a patent portfolio relating to a cardiothoracic surgery system owned by Medcanica, LLC. The portfolio consists of 14 U.S. issued patents, 4 non-U.S. patents, and 1 U.S. patent application.

17 Feb 2010

APCER PHARMA to demonstrate pharmacovigilance/drug safety and regulatory services at GPhA meeting

APCER PHARMA executives will discuss and demonstrate their expertise in providing generic drug manufacturers with the best in class pharmacovigilance/drug safety, regulatory and risk management services at the GPhA Annual Meeting, February 16-18, at the Ritz-Carlton in Naples, Florida. APCER will be in Booth #27.

17 Feb 2010

ViewRay earns NorTech Innovation Award for advancements in cancer radiation therapy technology

ViewRay, Inc., a privately held medical device company, has earned a NorTech Innovation Award for its advancements in radiation therapy technology for the treatment of cancer. ViewRay was honored for its unique combination of medical imaging and radiotherapy, which is designed to improve the effectiveness of cancer treatments. Radiation therapy is used to treat nearly two-thirds of today's cancer patients.

17 Feb 2010

Osseon Therapeutics completes first Osseoplasty procedures in Europe

Osseon Therapeutics Inc. today announced it has completed its first Osseoplasty™ procedures in Europe. The procedures were performed in Milan, Italy.

17 Feb 2010

New research report on orthopedic biomaterials market in the U.S.

According to a new global report series by iData Research (www.idataresearch.net), the leading authority in medical device, dental and pharmaceutical market research, the U.S. market for orthopedic biomaterials grew by 11.5% in 2009 and is estimated to reach almost $6.3 billion by 2016.

17 Feb 2010

Solos Endoscopy announces new polymer dilator for MammoView Breast Endoscopy System

Solos Endoscopy, Inc. is pleased to announce the Company has designed and is set to develop a new polymer dilator for the MammoView™ Breast Endoscopy System. The MammoView™ System currently offers a dilator set with a metal housing. The newly redesigned dilator utilizes a polymer housing, which is significantly softer while still offering comparable durability to the metal dilator. The new polymer dilator will be offered in addition to the more commonly used metal dilator. The two versions of the dilator offer physicians options based on individual patient's requirements.

16 Feb 2010

AGA Medical Holdings announces fourth-quarter and full-year 2009 financial results

AGA Medical Holdings, a leading developer of interventional medical devices for the minimally invasive treatment of structural heart defects and vascular abnormalities, today reported financial results for the fourth quarter and full year ended Dec. 31, 2009.

16 Feb 2010

Bluestar Silicones launches new line of Silbione products for medical applications

Bluestar Silicones is launching a new line of TCS 7560 and TCS 7561 Silbione(R) products designed for the elastic band market for lingerie and medical applications (support stockings and medical equipment). These two new silicone elastomers have excellent "anti-slip" non-compression properties, thus improving wearer comfort.

16 Feb 2010

Medical Devices News and Research

FDA may drop medical device 'fast track' amid overuse concerns

IMS Health launches IMS Aggregate Spend Compliance Services

Anulex Technologies announces the commercial availability of Xclose Plus Tissue Repair System

CryoLife discloses financial results for fourth-quarter and full-year 2009

Medline Industries signs exclusive distribution agreement with Derma Sciences for BIOGUARD Barrier Dressings

West Pharmaceutical Services reports 19.9% growth in consolidated fourth-quarter sales

AdvanSource Biomaterials reports 2.9% decrease in third-quarter revenue

Olympus launches new medical devices for LESS surgery

Ardiem Medical receives non-exclusive license to make and sell neuromodulation devices

IH Systems selects Robotic IV Automation Systems for cytotoxic drug preparation

Derma Sciences announces pricing of public offering of 972,000 shares of its common stock

Beating animal heart created: University of Minnesota signs global license agreement with Miromatrix Medical

ICAP Ocean Tomo offers Medcanica's patent portfolio for sale

APCER PHARMA to demonstrate pharmacovigilance/drug safety and regulatory services at GPhA meeting

ViewRay earns NorTech Innovation Award for advancements in cancer radiation therapy technology

Osseon Therapeutics completes first Osseoplasty procedures in Europe

New research report on orthopedic biomaterials market in the U.S.

Solos Endoscopy announces new polymer dilator for MammoView Breast Endoscopy System

AGA Medical Holdings announces fourth-quarter and full-year 2009 financial results

Bluestar Silicones launches new line of Silbione products for medical applications

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