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BioWorld - Tuesday, February 17, 2026
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 7, 2011

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FDA clears HE4 test in ROMA for ovarian malignancy risk

The FDA has cleared a new test from Fujirebio Diagnostics (Malvern, Pennsylvania) that is expected to help physicians assess whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of malignancy. Fujirebio says its HE4 test was cleared for use in the Risk of Ovarian Malignancy Algorithm (ROMA). (Medical Device Daily) Read More

GI Dynamics to begin trading shares on Australian exchange

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International report: Magnetecs' CGCI sold to Yonsei University Severance Hospital

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Washington roundup: FTC forces DaVita to sell clinics for DSI acquisition

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Deals roundup: AmerisourceBergen completes $35M IntrinsiQ acquisition

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HIT roundup: JACR shows radiologists strategies in using EHRs

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Agreements/contracts: Urologix signs license for Medtronic's Prostiva RF

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Financings roundup: Universal extends expiration for exchange offer to Friday

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Product Briefs

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Court Report: UT Southwestern, Parkland settle upcoding allegations

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People in the News

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Pinnacle ENT uses Xoran CT scan

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MDD's Oncology Extra

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