Tag: FDA clearance
FDA Approves AiRTouch Portable X-Ray, Could Be Potentially Used For COVID-19 Diagnosis
Aspenstate, a Plano, Texas-based medical technology company, announced that it has received FDA clearance for its portable X-ray system, AiRTouch. The lightweight X-ray system...
Headsafe Earns FDA Clearance For Its Brain Assessing Headset
Sydney, Australia-based brain health technology company Headsafe received FDA 510(K) clearance for its Nurochek brain-function assessment system. This news means the company will be...
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...
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...
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’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...