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Fdanewsdevicedailybulletin

Feb. 8, 2005

Vol. 2 No. 27

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FDA Renews Nationwide Alert on IV Flush

The FDA has reissued a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by IV Flush and distributed by Pinnacle Medical Supply of Rowlett, Texas.

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St. Jude Announces European Market Launch of QuickSite

St. Jude has announced the European market launch of the QuickSite 1056T bipolar left-heart pacing lead, the world's first cardiac resynchronization therapy lead to combine bipolar pacing capability with a composite body for superior handling and a unique S-shaped distal tip for outstanding stability.

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Kensey Nash Updates TriActiv System Regulatory and Sales Status

Kensey Nash has said it is in the process of responding to requests from the FDA regarding its 510(k) application for the TriActiv System.

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Vivosonic's Integrity Receives FDA Approval

Vivosonic, a Toronto-based medical device developer, has announced FDA approval for Integrity, a wireless objective hearing-assessment system, the company said.

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U.S.-Based Medical Devices Company LMA Plans Singapore Listing

A U.S.-based medical devices company, LMA International, is preparing for a Singapore listing in a move that will test the local appetite for companies operating in the high-risk, high-growth biomedical industry.

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HemoGenix Announces the Release of OxyFLOW

HemoGenix has made available its proprietary OxyFLOW Research Kit. HemoGenix, in collaboration with Biotrin International, developed a flow cytometric assay for detecting and quantifying oxidative DNA damage to lympho-hematopoietic cells.

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Medical Services Begins Shipping Its VScan Test Kits Into Russia

Medical Services has begun shipping its VScan HIV test kits into Russia.

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Abbott Enters Into Agreement With Cleveland Clinic for MPO Test

Abbott has entered into a licensing agreement with The Cleveland Clinic for the development of an automated in vitro diagnostic test to detect myeloperoxidase (MPO), an enzyme found in white blood cells.

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Biosite Announces License Agreement for Novel Diagnostic Targets

Biosite, a research-based provider of novel, rapid medical diagnostics, has exercised a semi-exclusive license for research and diagnostic purposes to a proprietary target, and has received an exclusive option to obtain licenses for 50 other diagnostic targets, under its collaboration and license agreement with Incyte.

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Syneron Announces Intention to Launch Secondary Offering

Syneron Medical, an innovator in the development, marketing and sales of ELOS combined-energy medical aesthetic devices, has announced it intends to file a registration statement with the SEC for a public offering of up to 8,050,000 of its ordinary shares.

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BioE Receives $8.3 Million in Funding From Private Investors

BioE, a biotechnology company developing antibody-based technology platforms for therapeutic and diagnostic applications, has received $8.3 million in its latest round of private financing.

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San Francisco County First in U.S. to Diagnose TB With QuantiFERON

As part of its steadfast effort to control the spread of tuberculosis (TB), the San Francisco Health Department became the first county health department in the U.S. to use QuantiFERON-TB GOLD, an indirect test for TB infection, according to Cellestis.

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OrthoClear Announces OrthoClear System, Issues Lawsuit Response

OrthoClear has announced the upcoming release of its OrthoClear System, a series of clear plastic aligners designed to straighten teeth.

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Texas Woman Sues Maker of LADARVision

A Lubbock County, Texas, woman is suing the Fort Worth maker of a laser system used by doctors to perform LASIK eye surgery.

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