FDA Approvals

FDA Authorizes First Interoperable Insulin Pump Intended to Allow Patients to Customize Treatment Through their Individual Diabetes Management Devices

“Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible,” said FDA Commissioner Scott Gottlieb, M.D. “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently. Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology. We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies.

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The Food and Drug Administration (FDA) Just Approved a Diagnostic Test to Assist Healthcare Providers in Measuring Nutrients in Breast Milk

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The FDA reviewed data submitted by the sponsor of 112 samples of human milk to analyze the performance of the device. For the study, the sponsor tested the same 112 samples in the machine and compared them to the expected true values obtained by independent methods; both systems provided similar results for each test. The data showed that the Miris Human Milk Analyzer test was effective at determining levels of protein, fat and carbohydrate in the milk. There may be conditions that limit the information available from the Miris Human Milk Analyzer. For example, certain medications that a nursing mother may be taking could interfere with the test’s ability to accurately measure nutrient levels in breast milk.

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