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Garmin notes that the use of wearables as health and medical tools is rapidly evolving and the company is “committed to the development of wearables that can lead to the detection of serious health conditions.” Read More
The agency said 3D-printed devices are subject to the same pre- and post-market requirements as conventionally manufactured devices, but there are additional considerations. Read More
Improving analysis and data collection will require the development of common data elements for sex and gender to be included in some prominent medical device registries, said FDA Commissioner Scott Gottlieb. Read More