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Nuvo FDA clearance for INVU

Nuvo Awarded FDA Clearance for its Remote Pregnancy Monitoring System INVU

Nuvo, a private company that makes pregnancy monitoring wearables, announced that it has received clearance from the U.S. Food & Drug Administration to market...
INNOVO Wearable for Stress Urinary Incontinence

Atlantic Therapeutics Wins FDA Clearance for INNOVO Non-Invasive Wearable for Stress Urinary Incontinence

Atlantic Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter clearance to INNOVO, a non-invasive, clinically proven and wearable device...
BioIntelliSense BioSticker FDA clearance

Denver Startup Receives FDA Clearance for its BioSticker On-Body Sensor for Remote Patient Monitoring

BioIntelliSense, a company making sticker-like sensors that can monitor patient vitals, received FDA 510(k) clearance of the BioSticker™ on-body sensor for scalable remote care....
Eko AFib detection algorithm

Eko’s AI-Powered AFib and Heart Murmur Detection Algorithms Get FDA Clearance

Eko, a maker of expensive digital stethoscopes, has received the first FDA clearance for its devices to use AI algorithms to automatically detect atrial...
Cochlear Osia 2 FDA clearance

Cochlear Receives FDA Clearance for its Innovative Osia 2 Hearing Implant System

Cochlear, a leading implantable hearing devices manufacturer, received FDA clearance of its Osia® 2 System. The Osia System is the world's first active osseointegrated...
Tandem t slim X2 insulin pumpTandem t slim X2 insulin pump

FDA Authorizes Tandem’s Interoperable, Automated Insulin Dosing Controller

Tandem Diabetes Care, a San Diego, CA-based insulin delivery and diabetes technology company, announced U.S. Food and Drug Administration (FDA) clearance of the company’s...