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BioWorld - Saturday, January 24, 2026
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 10, 2014

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FDA clears new biomarker test from Astute Medical for acute kidney injury

A new test used to assess risk for acute kidney injury (AKI) could help doctors significantly improve management of ICU patients and reduce costs to the healthcare system. Astute Medical (San Diego) said it has received FDA 510(k) clearance for its first biomarker-based immunoassay, the NephroCheck test system, designed to assess risk for AKI. Astute has designated Ortho-Clinical Diagnostics (Raritan, New Jersey) as the exclusive sales agent for the NephroCheck test. Read More

MDD's Perspectives: Strikeout! Three stories that barely missed home plate

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Aethlon, Exosome researchers develop lectin-based diagnostic platform

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Inside the Beltway: AdvaMed's Fish; House hearing changed little on FDA/LDT issue

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Financings: ReWalk hoping to garner $50 million through IPO

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World in Review: Apollo Hospitals and AliveCor combine in Indian collaboration

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Daily M&A: Alpheon in plan to acquire all outstanding shares of Clarion

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People in Places

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Briefly noted

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Agreements/contracts: Accuray signs radiation contract with Premier

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Products

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MDD's Oncology Extra

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