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Insulin Pumps Recalled

The Food and Drug Administration (FDA) recently alerted consumers that Medtronic was recalling their MiniMed™ 508 insulin pump and MiniMed™ Paradigm™ Series insulin pump models. They discovered that the pumps were vulnerable to being hacked and could not be updated to correct the issue. The recalled Medtronic pumps could connect wirelessly to equipment, such as monitoring systems and » Read More

What is the Difference Between FDA-Approved and FDA-Cleared Medical Devices?

The types of products that are subject to Food and Drug Administration (FDA) approval are more extensive than one might think. In addition to prescription drugs and foods, the FDA evaluates cosmetics, vaccines, over-the-counter-drugs, infant formula, surgical implants, and medical devices. Although this testing is essential for public health and safety, the system is not » Read More