Tag: FDA

The Advanced Biohacking Tool Once Reserved for Elite Athletes Is Now Available to Anyone

Withings Redefines At-Home Family Healthcare in the US with FDA Clearance of BeamO

Aktiia’s Hilo Band Becomes First Cuffless Blood Pressure Monitor Cleared by FDA for Over-the-Counter Use 

Fasikl Receives FDA Clearance for Felix NeuroAI Wristband, the First and Only AI-Powered Treatment for Essential Tremor

Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe

First Ever Conversation Amplifying Earphones

Samsung’s Sleep Apnea Feature on Galaxy Watch First of Its Kind Authorized by US FDA

Masimo Receives FDA Clearance for Stork™ Baby Monitoring System

Masimo W1™ Medical Watch Receives FDA 510(k) Clearance for Over-the-Counter and Prescription Use

Withings Announces US Availability of its Body Scan Connected Health Station That Records a 6-Lead ECG, Assesses Nerve Activity and Measures Segmental Body Composition