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Fdanewsdevicedailybulletin

Jan. 6, 2005

Vol. 2 No. 4

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VISIONCARE CLOSES $20 MILLION SERIES D FINANCING

VisionCare Ophthalmic Technologies, a developer of proprietary visual prosthetic devices for the treatment of age-related macular degeneration (AMD) and other central vision disorders, has closed a Series D financing totaling $20 million.

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FDA CLEARS GENTLEWAVES TO TREAT PERIORBITAL WRINKLES, RHYTIDS

Light BioScience has announced that the FDA cleared GentleWaves Light Emitting Diode (LED) Photomodulation System for the noninvasive treatment of periorbital -- eye area -- wrinkles and rhytids.

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AUSTRALIA'S VENTRACOR TAKES LEGAL ACTION AGAINST FLORIDA-BASED HEARTWARE

International medical technology company Ventracor has initiated legal action in the U.S. District Court for the Southern District of Florida against Heartware.

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ASTRA TECH APPOINTS NEW U.S. CEO

Astra Tech, part of the AstraZeneca group that develops and manufactures dental implants and medical devices for surgery and urology, has appointed Scott Root as president and CEO.

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CARDIOMAG SIGNS MULTIYEAR SALES AGREEMENT WITH CHINESE DISTRIBUTOR

CardioMag Imaging (CMI), located in Schenectady, N.Y., has announced the signing of a multiyear distribution agreement with a medical equipment company, Shenzhen Zhiheng Advanced Electrical Technology, located in Shenzhen, China.

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RESPONSE BIOMEDICAL'S RAMP SYSTEM RECEIVES MARKET CLEARANCE IN CHINA

Response Biomedical has announced that the RAMP Reader and three RAMP Cardiac Marker Tests have received regulatory clearance in China from the State Food and Drug Administration (SFDA).

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GEN-PROBE LICENSES FROM CORIXA RIGHTS TO DEVELOP MOLECULAR DIAGNOSTIC TESTS

Gen-Probe has licensed from Corixa the rights to develop molecular diagnostic tests for approximately 50 potential genetic markers in the areas of prostate, ovarian, cervical, kidney, lung and colon cancer, the companies announced.

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DADE BEHRING RECEIVES FDA CLEARANCE FOR USE OF ITS ADVANCED D-DIMER ASSAY

Dade Behring has received clearance from the FDA for the use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism -- deep vein thrombosis or pulmonary embolism.

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DEXCOM COMPLETES SERIES D PREFERRED STOCK FINANCING FOR $22.5 MILLION

DexCom, a developer of sensors to continuously monitor glucose levels in people with diabetes, has completed a private Series D financing totaling $22.5 million.

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VIVANT MEDICAL SPONSORS INVESTIGATIONAL STUDY TO EVALUATE MICROWAVE ABLATION FOR THE TREATMENT OF LIVER TUMORS

Vivant Medical announced an ongoing investigational study to determine the effectiveness of microwave ablation for treatment of liver tumors.

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CT LASER MAMMOGRAPHY DISTRIBUTOR SELECTED FOR TURKEY

Imaging Diagnostic Systems has announced that Kurt & Kurt has been appointed the exclusive distributor in Turkey.

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JOHN LEMLEY APPOINTED ZEVEX CHAIRMAN

The board of directors of devicemaker ZEVEX International have announced that the responsibilities of chairman of the board and CEO will be separated as a matter of good corporate governance.

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DISINTEGRATOR NEEDLE DESTRUCTION DEVICE COMMENCES GLOBAL DISTRIBUTION

Safeguard Medical Technologies of Cleveland, Ohio, has joined forces with British firm Environmental Asset Management (EAM) to distribute worldwide the Disintegrator, a needle/lancet destruction device.

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RADIOLOGIX NAMES MICHAEL MURDOCK CFO

Radiologix, a radiology services company that develops, consolidates and manages radiology service networks, announced that Michael Murdock has been appointed senior vice president and CFO.

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