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July 11, 2006

July 11- July 17

July 11th: FDA Approves Fuji's Digital Mammography System for Use in the U.S.

The Food and Drug Administration (FDA) has just approved what is already the world's most widely-used digital mammography technology to be sold now in the United States. FUJIFILM Medical Systems USA can now offer the benefits of its high performance, cost-effective digital mammography system, Fuji Computed Radiography for Mammography (FCRm), to facilities nationwide.

A landmark clinical study of 49,528 women found that digital mammography has significant benefits over conventional film-screen mammography in detecting breast cancer in three groups of women. Unlike other digital mammography systems, Fuji's computed radiography for mammography does not require replacing the existing mammography x-ray unit. This significantly lowers facilities' conversion costs. Instead of a complete system overhaul, with FCRm the film cassettes are simply replaced with FCR cassettes. After the exam, the digitally acquired information is sent to the diagnostic workstation for interpretation.

As one of the Fuji Photo Film family of companies with 70 years of imaging experience and almost $25 billion in sales, FUJIFILM Medical Systems is a leading provider of diagnostic imaging products and network systems to meet the needs of healthcare facilities today and well into the future. Fuji's family of Imaging Systems products and technologies--including digital x-ray, women's healthcare imaging, dry imagers, and conventional x-ray film and equipment--are tailored to suit many different applications for a variety of imaging environments.
 

July 12th: VIASYS Healthcare Inc. Acquires Tiara Medical Systems, Inc.

VIASYS Healthcare Inc. and Tiara Medical Systems, Inc. ("Tiara Medical") announced today that VIASYS has acquired Tiara Medical - a company focused in the sleep therapeutic market. VIASYS is a leading global competitor in pulmonary, neurological and sleep diagnostics, as well as within the critical care segment.

Based in Oak Forest, Illinois, Tiara Medical designs, manufactures, markets, and sells Continuous Positive Airway Pressure (CPAP) masks, headgear, circuits, and filters. These products are complemented by a comprehensive product line of specialty filters and accessories for oxygen concentrators and mechanical ventilators. Tiara Medical offers home health care providers the convenience of a comprehensive range of products to meet the needs of patients receiving treatment for Obstructive Sleep Apnea (OSA) and other chronic respiratory diseases. Tiara Medical recently introduced The Advantage Series(TM) Full Face Mask and the Snapp-X(TM) Direct Nasal Interface.

Under the terms of the acquisition agreement, VIASYS acquired all of the outstanding stock of Tiara Medical through one of its subsidiaries for consideration of approximately $24.3 million. VIASYS financed the acquisition with cash and borrowings under its revolving credit facility. Tiara's 2005 revenues were $10.3 million, and the company has grown approximately 15% compounded over the last three years.
 

July 12th: Smith & Nephew Launches Innovative TRIGEN(TM) INTERTAN(TM) Nail for Femoral Fractures

Smith & Nephew's Orthopaedic Trauma & Clinical Therapies division today announced the launch of the TRIGEN(TM) INTERTAN(TM) Intertrochanteric Antegrade Nail for the treatment of femoral fractures.

The TRIGEN INTERTAN nail is indicated for the treatment of femoral fractures, or a break in the thigh bone, which runs from the hip to the knee and is the longest and strongest bone in the body. A femoral fracture is typically caused by direct trauma to the bone and requires an average of six to eight weeks to heal. There are approximately 250,000 hip fractures a year in the U.S.; hip fractures are expected to double to 500,000 by 2040.

The TRIGEN INTERTAN nail features an innovative two-screw configuration that secures the nail in place after surgery, acting together to provide greater stability for the bone and reduced healing time. Previous generations of intramedullary nails for femoral fractures used a single screw that sometimes contributed to a loosening of the device.

Smith & Nephew's development engineers, as well as a team of surgeons including Dr. Toney Russell of Memphis, Tennessee, designed and developed the TRIGEN INTERTAN nail and its two-screw system. With more than 200 clinical cases already completed, the improved results include earlier weight bearing by patients and shorter healing times.

The TRIGEN INTERTAN nail for femoral fractures is clinically proven to reduce healing time, allowing patients to regain their mobility more quickly. Smith & Nephew is a global medical technology business, specializing in Orthopaedic Trauma & Clinical Therapies, Orthopaedic Reconstruction, Endoscopy and Advanced Wound Management products. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies. Smith & Nephew is dedicated to helping improve people's lives.
 

July 13th: BIOLASE Announces FDA Clearance of Its OCULASE MD(TM) Laser System for Ophthalmology.

BIOLASE Technology, Inc. a medical technology company that develops, manufactures and markets lasers and related products focused on technologies for improved applications and procedures in dentistry and medicine, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing it to market its OCULASE MD(TM) Laser System for general ophthalmic soft tissue surgical indications.

FDA-cleared indications for the OCULASE MD include the incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit. This represents the first Er,Cr:YSGG laser system cleared for ophthalmic applications.

BIOLASE Technology, Inc. (http://www.biolase.com) is a medical technology company that develops, manufactures and markets lasers and related products focused on technologies for improved applications and procedures in dentistry and medicine. The Company's products incorporate patented and patent pending technologies focused on reducing pain and improving clinical results. Its primary product, the Waterlase® system, is one of the best selling dental laser systems.
 

July 13th: Cordis Corporation Acquires Ensure Medical, Inc.

Cordis Corporation, a Johnson & Johnson company, the worldwide leader in cardiac and vascular technologies, today announced that it has acquired Ensure Medical, Inc., a privately held company in Sunnyvale, Calif., that develops devices for post-catheterization closure of the femoral artery.

The lead investigational technology from Ensure Medical is a femoral artery closure device (ACD), which uses a synthetic bioabsorbable polymer to stop bleeding and close the site of the arterial puncture. ACDs are designed to enable expedited closure time and reduce bed-stay when compared to conventional manual compression methods for wound access site closure. Nearly eight million patients undergo cardiac catheterization procedures annually.

The acquisition of Ensure Medical further expands Cordis' presence on the West Coast, which includes Nitinol Devices and Components (NDC), and the West Coast Innovation Center, a new state-of-the-art advanced research and development facility in the San Francisco Bay Area of California. The development program for the new ACD, NDC and the recently announced West Coast Innovation Center are under the leadership of Cordis' Chief Technology Officer, Campbell Rogers, M.D. who joined the company in early July.

As a result of the acquisition, Johnson & Johnson expects to incur an estimated one-time after-tax charge of approximately $52 million, or $.02 per share, related to the expensing of in-process research and development. Other terms of the transaction were not disclosed. Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional cardiac and vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from cardiac and vascular disease.

 

 

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