Insuline pump hits FDA obstacle

Israel's Insuline hit a roadblock in its plans to get the novel InsuPatch pump on the U.S. market. The devicemaker was on its way through the FDA's 510(k) clearance process when the agency decided InsuPatch needed to file as a drug-device combination, meaning Insuline must file an IND to gain approval, Globes reports. Insuline said gathering and submitting additional data will take time and money, according to the news agency, and the company is weighing its response. Report

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