Insuline's InsuPatch delivery device suffers FDA setback

The FDA dealt Israel's Insuline a blow this week when it rejected the company's application for InsuPatch, a novel fast-working insulin-delivery device, on the grounds that not enough information was available about the device and the safety and efficacy of its use, according to Globes' report. Because of InsuPatch's mechanism of delivery, the company must submit an IND on top of its previous 510(k) de novo application. The device increases absorption of insulin by increasing blood flow at the injection site with heat. More

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