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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 clinicians monitor patients in multiple healthcare settings – from the hospital to the home. Read more Abbott Receives FDA Approval for Gallant Heart Rhythm Implants […]
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, which enables clinicians to optimize device settings without the need for patients to return to the office or hospital. The LINQ II system also delivers […]
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 fibrillation (AF), cryptogenic stroke and syncope. Read more Fitbit Launches Large-Scale Study To See If Its Wearables Can Detect Atrial Fibrillation The new LUX-Dx ICM […]
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 older with diabetes. FreeStyle Libre 2  is the only iCGM system with optional real-time alarms that measures glucose levels every minute, meeting the highest level […]
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 Symbicort Inhaler to its digital health platform. Read more S3 Connected Health Deploys Tool For Assessing COVID-19 Risk of Respiratory Deterioration Propeller’s platform already connects […]
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 could be particularly useful for quickly obtaining chest X-rays of COVID-19 patients. Read more S3 Connected Health Deploys Tool For Assessing COVID-19 Risk of Respiratory Deterioration The AiRTouch device offers a […]