5 medical wearables cleared by the FDA in 2019

Here are five wearable devices that have received FDA clearance or approval for medical use in the first half of 2019:

1. The IB-Stim is a prescription-only, battery-powered electrical nerve stimulator worn behind the ear that emits low-frequency electrical pulses to the brain. It is the first device to treat patients aged 11 to 18 for abdominal pain associated with irritable bowel syndrome.

2. VivaQuant's RX-1 continuously monitors a patient's ECG to detect cardiac arrhythmias; when a potential arrhythmia is identified, the device transfers that information first to a monitoring center for review, then to the patient's physician.

3. The AI-powered KardiaMobile, from AliveCor, detects atrial fibrillation, normal sinus rhythm, bradycardia and tachycardia in its ECG readings, captured via a small touchpad that can be connected to a user's smartphone.

4. Current Health's patient monitoring platform comprises a smartphone-sized device attached to an upper arm band that measures vital signs in real time and uses AI to detect warning signs and potential health declines.

5. The Monarch eTNS system is the first FDA-cleared digital medical device for the treatment of ADHD in children. The smartphone-sized device emits low-level electrical pulses through a wire to a small patch attached to a patient's forehead to send therapeutic signals to the brain.

More articles about health IT:
Global health experts urge Google, Facebook to crack down on spread of vaccine misinformation
In-basket messages sent from the EHR may drive physician burnout, study finds
AMA: Proposed federal interoperability rules will impact patient safety

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars