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Boston Scientific Lux Dx FDA clearance

Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx Implantable Cardiac Monitor System

Boston Scientific has received FDA 510(k) clearance for its LUX-Dx Insertable Cardiac Monitor (ICM) System, a new, long-term implantable diagnostic device to detect arrhythmias...
Abbott Freestyle Libre 2 FDA Clearance

Abbott’s Freestyle Libre 2 iCGM Receives FDA Clearance For Adults And Children With Diabetes...

Abbott, the worldwide leader in continuous glucose monitoring (CGM), received FDA clearance for its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system for...
Propeller Health Receives FDA Clearance

Propeller Health Receives FDA Clearance For Its Sensor To Work With Symbicort Inhaler

Propeller Health, a leading digital health company dedicated to the management of asthma and COPD, announced it has received 510(k) clearance from the US...
AiRTouch Portable X-Ray

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 NUROCHEK 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 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...