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Nanowear SimpleSENSE FDA Clearance

Nanowear’s Cloth-Based Wearable Remote Monitoring Platform SimpleSENSE Cleared By FDA

Nanowear, a leading connected-care and remote diagnostic platform, announced it has received FDA Class II 510(k) clearance for a first-of-its-kind cloth-based diagnostic platform, SimpleSENSE. SimpleSENSE is a multi-parameter remote diagnostic […]
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Vitls Wins FDA Clearance

Vitls Wins FDA Clearance For Its Remote Patient Monitoring Platform

Houston, Texas-based Vitls Inc. won FDA 510(k) clearance for its Vitls Platform. The Vitls Platform is a combination of a vitals monitoring patch, cloud storage, and an app that lets […]
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Medtronic LINQ II FDA clearance

Medtronic Wins FDA Clearance And CE Approval For LINQ II Insertable Cardiac Monitor

Medtronic, the global leader in medical technology, announced it has received U.S. FDA clearance and European CE Mark approval for its LINQ II insertable cardiac monitor (ICM) with remote programming, […]
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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 associated with conditions such as atrial […]
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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 adults and children ages 4 and […]
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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 FDA to connect patients using the […]
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