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  • Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System
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Category: Patient Monitoring

Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System

Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System

iData Research 08/07/2020
Boston Scientific has been granted FDA 510(k) clearance for their LUX-Dx insertable cardiac monitor system. This long-term diagnostic device is used to detect arrhythmias from conditions such as atria... Read More
Beckman Coulter Granted FDA EUA for COVID-19 IgG Antibody Test

Beckman Coulter Granted FDA EUA for COVID-19 IgG Antibody Test

iData Research 07/07/2020
Beckman Coulter has been granted Emergency Use Authorization by the FDA for its new COVID-19 antibody test. This approval comes after being tested by the top four in vitro diagnostic manufacturers in ... Read More
Abbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor

Abbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor

iData Research 07/07/2020
The most recent integrated continuous glucose monitor (iCGM) from Abbott, the Freestyle Libre 2, has been granted FDA approval for sale in the U.S. to adults and children over the age of four with dia... Read More
Bardy Diagnostics Given CE Mark for Cardiac Monitoring Patch

Bardy Diagnostics Given CE Mark for Cardiac Monitoring Patch

iData Research 02/06/2020
Bardy Diagnostics‘ 14-day Carnation Ambulatory Monitor (CAM) patches have previously been used in U.S. hospital settings, but they have now been granted a CE mark for these products. The patches... Read More
Aspenstate Portable X-Ray Device Granted FDA Approval

Aspenstate Portable X-Ray Device Granted FDA Approval

iData Research 27/05/2020
The FDA has recently granted clearance for the portable AiRTouch X-ray device developed by Aspenstate to be used for humans. This small, handheld device joins the array of telehealth products being de... Read More
Philips Granted FDA Clearance for Ultrasound Devices to Manage COVID-19 Complications

Philips Granted FDA Clearance for Ultrasound Devices to Manage COVID-19 Complications

iData Research 26/05/2020
The FDA has recently granted 510(k) clearance to Philips for a range of its devices to be used to manage COVID-19 patients in the U.S. The approved products include the Affiniti series, EPIQ series, L... Read More
Cloud-Based Remote Ventilator Monitoring Implemented by ResMed

Cloud-Based Remote Ventilator Monitoring Implemented by ResMed

iData Research 13/05/2020
In Europe, respiratory device manufacturer ResMed has accelerated their process of launching remote tracking of ventilators, to combat the ongoing COVID-19 crisis. This cloud-based technology provides... Read More
BioButton Mobile Device Tracks COVID-19 Symptoms for 30 Days

BioButton Mobile Device Tracks COVID-19 Symptoms for 30 Days

iData Research 07/05/2020
BioIntelliSense has created a multi-symptom tracking device called the BioButton to conveniently measure health metrics, as part of the ongoing efforts to track and control the spread of COVID-19. Thi... Read More
Non-Invasive Throat Sensor Developed to Track COVID-19 Symptoms

Non-Invasive Throat Sensor Developed to Track COVID-19 Symptoms

iData Research 04/05/2020
A new device has been developed to measure physical symptoms in COVID-19 patients. This non-invasive device allows medical personnel to monitor a variety of symptoms with a singular device. This throa... Read More
Bardy Dx Patch Monitors Coronavirus Patients Prescribed HCQ

Bardy Dx Patch Monitors Coronavirus Patients Prescribed HCQ

iData Research 01/04/2020
Bardy Diagnostics‘ Carnation Ambulatory Monitor (CAM™) Patch is being used by Seattle health care workers to monitor heart beat and measure QT segments in coronavirus patients prescribed HCQ e... Read More
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