Empatica wins FDA nod for Embrace seizure-tracking wristband

Wearable med device firm Empatica said today it won FDA clearance for its Embrace seizure-tracking wristband. The Embrace device is designed to detect and monitor stress signals and detect seizures that could potentially be deadly, the Cambridge, Mass.-based company said. The wrist-worn Embrace looks like a fitness tracker and is equipped with temperature sensors to detect changes in body heat, gyroscopes and accelerometers to detect movement and an EDA sensor to detect electric changes in the skin. The system also uses advanced machine learning to monitor for grand mal seizures and sends alerts to caregivers. “It’s been quite the journey – we have worked for years building wearable stress and emotion sensors, and then accidentally discovered we could pick up changes in the skin elicited by brain activity related to the most dangerous kinds of seizures. It has been very meaningful to see this technology move from the lab into the most accurate, beautiful and easy to use sensor on the market,” Empatica chief scientist Rosalind Picard said in a press release. “Medical devices face a huge problem: they’re usually too bulky and uncomfortable, and people simply don’t want to wear them. Empatica took a different path. We wanted to design the world’s first medical device that could win a design award, while being used as a lifesaving product. Patients actually love Embrace and are proud to wear it. We think this has been one ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Patient Monitoring Regulatory/Compliance Empatica Source Type: news

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