Posts filed under: Patient Monitoring

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...
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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...
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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...
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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...
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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,...
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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...
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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...
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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...
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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...
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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 throat sensor, developed by the Shirley Ryan Ability Lab and...
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