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FDA Publishes Guidance for Wireless Medical Devices

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Maintaining the balance between innovation and safety

Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance. Data from a patient-worn or implanted medical device goes directly to the health care professional. The transfer of data is immediate, accelerating communication, decision time, and when necessary, intervention.

However, the stakes can get high.

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