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Fdanewsdevicedailybulletin

Jan. 10, 2005

Vol. 2 No. 6

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HAEMONETICS GETS FDA CLEARANCE FOR CARDIOPAT

Medical device company Haemonetics has reported the FDA cleared its CardioPAT surgical blood salvage system.

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ETHICON'S ULTRAPRO MESH AS STRONG AS HEAVIER-WEIGHT PRODUCTS

Ethicon has announced the results of a study demonstrating that the company's ULTRAPRO Partially Absorbable Lightweight Mesh provides high initial burst strength during the critical time period of tissue-mesh incorporation.

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BIOPHAN EXECUTES LETTER OF INTENT TO ACQUIRE AMRIS

Biophan Technologies, a developer of next-generation biomedical technology, entered into a letter of intent to acquire a leading German-based developer of magnetic resonance imaging (MRI)-safe and image-compatible technology solutions and biomedical devices.

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BIOFIELD RESPONDS TO FDA 'NONSUBSTANTIAL EQUIVALENCE' DETERMINATION

Biofield, developer of the Biofield Breast Proliferation Rate Detection System (BDS) -- a noninvasive, radiation-free adjunctive test system that may be of assistance in the evaluation of suspicious breast lesions -- has submitted a petition to the FDA requesting reclassification of the BDS.

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NIR DIAGNOSTICS RECEIVES $1 MILLION LICENSING AGREEMENT PAYMENT

NIR Diagnostics, a leading-edge developer of near-infrared diagnostic instruments, has received a $1 million payment as a result of a licensing agreement between Spectromedical, of Cambridge, Ontario, and a third-party licensee.

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DOBI MEDICAL INTERNATIONAL FURTHER EXPANDS DISTRIBUTION NETWORK

DOBI Medical International has expanded its international presence by signing new distribution agreements with Biomedica Life Sciences in Athens, Greece, and Nova-Logic in Montreux, Switzerland, for the DOBI Medical ComfortScan system.

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MICROLIFE LAUNCHES FIRST EVER DIGITAL PEAK FLOW METER WITH FEV-1 IN RETAIL PHARMACIES

Microlife launched the first digital peak flow meter that also provides FEV-1 measurement through its first major retail chain partner.

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OUTCOMES BASED ON THE USE OF ON-Q PAINBUSTER FOLLOWING MASTECTOMY PRESENTED AT NATIONAL BREAST CANCER MEETING

I-Flow announced that Volker Jacobs and John Morrison of the Fayette Medical Center (FMC) presented data highlighting benefits of ON-Q PainBuster to reduce pain after mastectomy while reducing or eliminating the use of narcotics at the San Antonio Breast Cancer Symposium in December.

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AMERICAN BIO MEDICA GETS TEC4 FDA OK

Medical device company American Bio Medica has said that the FDA cleared its Rapid TEC4 drugs of abuse test and also received a Canadian patent related to its rapid drug screen product.

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CRYOFLUOR THERAPEUTICS CLOSES SECOND-ROUND INVESTMENT

CryoFluor Therapeutics, a medical device company developing a novel cryosurgical technology platform, has received a second investment that will allow the company to complete a feasibility clinical trial of its device to treat abnormal uterine bleeding.

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RITA MEDICAL TO PRE-PAY $6.5 MILLION IN DEBT RELATED TO HORIZON MERGER

RITA Medical Systems has announced its wholly owned subsidiary Horizon Medical Products entered into an agreement allowing it to repay $6.5 million in debt held by creditors of Horizon.

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AMDL FILES NEW APPLICATION WITH FDA

AMDL, developer and marketer of tests for the early detection of cancer and other serious diseases, has announced its consultant, Diagnostic Oncology Clinical Research Organization, submitted to the FDA, on behalf of AMDL, additional data and a new application for 510(k) clearance to market AMDL's DR-70 test as an aid in monitoring patients previously diagnosed with progressing colorectal cancer.

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NANOGEN NAMES ROBERT SALTMARSH CFO

Nanogen, developer of advanced diagnostic products, has announced the appointment of Robert Saltmarsh as CFO. Saltmarsh joined Nanogen as vice president of corporate development last September.

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DUKE CLINICAL RESEARCH INSTITUTE'S TRIAL OF RECOM'S HEART MONITOR IS UNDERWAY

Recom Managed Systems, in conjunction with the Duke Clinical Research Institute, of Durham, N.C., has announced its Sponsored Research trial is underway.

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