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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Nov. 5, 2013

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Report from Europe: GlySure completes CBGM CE mark trial enrollment

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Washington roundup: ACR, MITA applaud doc fix bill for appropriateness text

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Deals roundup: Kindred Healthcare inks definitive agreement to buy SHC for $95M

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Financings roundup: Exagen closes $25 million to spur new revenue growth

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HIT roundup: HealthCare Partners to expand its partnership with Allscripts

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Agreements/contracts: RaySearch to distribute RayStation via Hitachi

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Med-Tech Notes

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Product Briefs

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People in the News

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MDD's Cardio Extra

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Independent panel to review FzioMed's Oxiplex Gel PMA

Gaining regulatory approval for a new device in the U.S. is rarely an easy or short process, but for some medical device companies that journey is a heck of a lot longer than anticipated. One company that is all too aware of how difficult the FDA approval process can be is FzioMed (San Luis Obispo, California), which has been trying to get FDA approval for its Oxiplex Gel for 12 years. The company reported this week that the FDA has approved its petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel to be used during lumbar spine surgery. Read More

CINtec Plus Cytology test gets favorable results in PALMS study

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