FDA Approved Medtronic Insertable Cardiac Monitor

Medtronic announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ(TM) Insertable Cardiac Monitor (ICM) with TruRhythm(TM) Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats.

Reveal LINQ ICM with TruRhythm Detection offers exclusive algorithms that result in a 95 percent reduction in … Continue reading

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BIOTRONIK Receives FDA Approval of Insertable Cardiac Monitor

Biotronik announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI® technology.

BioMonitor 2 is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor … Continue reading

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Dexcom Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System

Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected.

Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including … Continue reading

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CFDA approves 2 non-invasive fingertip mounted device from CNOGA

CNOGA Medical has received China CFDA approval for two of their non-invasive fingertip devices for detection of bio-parameters. One product is named as the MTX, a novel Non-Invasive Fingertip mounted device designed to measure a wide range of physiological bio-parameters without the need to take painful invasive blood samples.
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