FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

Embrace is a wearable device worn on the wrist that monitors physiological signals such as Electrodermal Activity, motion, and temperature to detect generalized tonic clonic seizures in patients with epilepsy. It helps alert caregivers by sending notifications during seizure events, assisting in timely monitoring and care for patients both at home and in healthcare facilities.

FDA #
K181861
Product Code
POS
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