In 2018, the US FDA approved 106 IoT medical devices in comparison to 99 devices in 2017

28 Jan 2019

The US Food and Drug Administration (FDA) Commissioner, Dr Scott Gottlieb, and the Director of the Centre for Devices and Radiological Health, Dr Jeff Shuren, issued a statement on a record year for device innovation. According to the statement, the FDA approved 106 new IoT medical devices in 2018, compared to 99 devices in 2017. This reflects the ongoing policy of the FDA in recent years to promote the development and use of IoT medical devices and services in the USA. The statement also highlighted FDA’s plans to continue implementing the National Evaluation System for Health Technology (NEST) and other initiatives concerning the development of safe IoT medical devices.

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The Internet of Things (IoT) includes a wide range of Internet-connected devices, from highly digitalised cars, home appliances (e.g. fridges), and smart watches, to digitalised clothes that can monitor health. IoT devices are often connected in wide-systems, typically described as 'smart houses' or 'smart cities'.


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