Patient Monitoring

Vitls Inc. Granted FDA Clearance of Clinical-Grade Vital Sign Telemonitoring System for Hospital and Home Use

Vitls Inc. Granted FDA Clearance of Clinical-Grade Vital Sign Telemonitoring System for Hospital and Home Use

Vitls Inc., a company based out of Houston, Texas, has received 510(k) clearance from the FDA for its Vitls Platform, a telemonitoring system. This platform provides a streamlined process of vital sign monitoring by allowing healthcare providers to view several health metrics from a single device. This clinical-grade platform provides reliable and accurate monitoring in

iData ResearchVitls Inc. Granted FDA Clearance of Clinical-Grade Vital Sign Telemonitoring System for Hospital and Home Use
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Medtronic receives CE mark for Micra AV Pacemaker

Medtronic receives CE mark for Micra AV Pacemaker

Medtronic has received a CE mark for its Micra AV Pacemaker, the world’s smallest pacemaker with atrioventricular (AV) synchrony. This device is used to treat AV block, a condition marked by impaired neural signals between atrial and ventricular chambers in the heart. AV block can lead to irregular beat, and in some cases, increased risk

iData ResearchMedtronic receives CE mark for Micra AV Pacemaker
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Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System

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

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 atrial fibrillation, syncope, and cryptogenic stroke. The LUX-Dx’s multi-stage algorithm first detects potential arrhythmias, then verifies them. When an arrhythmia is verified, clinicians are immediately alerted, so

iData ResearchBoston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System
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Beckman Coulter Granted FDA EUA for COVID-19 IgG Antibody Test

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

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 the U.S. to validate its efficacy. This test is likely more effective than other tests, as most others test for the immunoglobulin (IgM)

iData ResearchBeckman Coulter Granted FDA EUA for COVID-19 IgG Antibody Test
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Abbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor

Abbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor

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 diabetes. The Freestyle Libre 2 has several innovative features. It is the only iCGM system that measures glucose levels each minute,

iData ResearchAbbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor
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Bardy Diagnostics Given CE Mark for Cardiac Monitoring Patch

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Bardy Diagnostics Given CE Mark for Cardiac Monitoring Patch

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 allow for a longer period of monitoring than previous products, that were used for 2 or 7-day periods. Longer monitoring periods provide healthcare providers with

iData ResearchBardy Diagnostics Given CE Mark for Cardiac Monitoring Patch
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Aspenstate Portable X-Ray Device Granted FDA Approval

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Aspenstate Portable X-Ray Device Granted FDA Approval

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 developed recently. This device is paired with a touchscreen for an intuitive interface, and it can upload images directly to clinical storage systems, without

iData ResearchAspenstate Portable X-Ray Device Granted FDA Approval
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Philips Granted FDA Clearance for Ultrasound Devices to Manage COVID-19 Complications

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

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, Lumify, CX50, and Sparq system. These ultrasound devices are used to monitor and manage patients suffering from COVID-19 complications. This range

iData ResearchPhilips Granted FDA Clearance for Ultrasound Devices to Manage COVID-19 Complications
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Cloud-Based Remote Ventilator Monitoring Implemented by ResMed

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Cloud-Based Remote Ventilator Monitoring Implemented by ResMed

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 healthcare professionals with clinical data while patients are at home. This tackles several issues related to the ongoing pandemic. Firstly, it may provide increased room in hospitals, as patients

iData ResearchCloud-Based Remote Ventilator Monitoring Implemented by ResMed
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BioButton Mobile Device Tracks COVID-19 Symptoms for 30 Days

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BioButton Mobile Device Tracks COVID-19 Symptoms for 30 Days

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. This non-invasive device allows data to be passively collected from individuals over a period of up to 30 days at a time. As restrictions begin to

iData ResearchBioButton Mobile Device Tracks COVID-19 Symptoms for 30 Days
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