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HiFi DNA Tech Tells FDA to Reduce Unnecessary Biopsies on Women
The Trumbull, CT-based HiFi DNA Tech wants the US Food and Drug Administration (FDA) to reduce unnecessary biopsies on women, by rescinding its approv...

FDA Announces Class I Recall of Ophthalmic Surgical Device
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured...

FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue
The U.S. Food and Drug Administration today approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two di...

FDA Prevents Two Dairies from Adulterating Animal Drugs and Food
The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Da...

FDA Approves First Imaging Agent to Enhance Scans of Blood Flow
The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients...

Trinity Biotech Files 510k for Destiny Max With FDA
Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets,...

FDA Warns Consumers About Tainted Weight Loss Pills
The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight ...

Agion Partners with Stryker Instruments to Introduce FDA 510k Cleared Catheters
Agion Technologies has announced it has signed an agreement with Stryker Corporation's Instruments Division to incorporate Agion's natural antimicrobi...

EDAP Submits 510 Filing to U.S. FDA for Sonolith I-Sys
EDAP announced that it has filed a 510(k) marketing application with the U.S. Food and Drug Administration (FDA) for its newly designed, high-end Sono...

IMRIS receives FDA clearance for 3 Tesla IMRISneuro
IMRIS announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's 3 Tesla IMRISneuro for sale in the U.S. IMRISneuro is now a...

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