Tagged medical device

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Integrated glucose system gains FDA approval

An integrated continuous glucose monitoring (iCGM) system for measuring sugar levels in children and diabetic adults has been given approval by the FDA. Compatible with certain medical devices and electronic interfaces, it is the first type of integrated system for continuous glucose monitoring to be permitted by the watchdog. The Dexcom G6 device is applied…

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Medical device accessory cleared for Apple Watch

The first medical device accessory for the Apple Watch has been cleared for use by the FDA. Apple Watch users can now discreetly capture their electrocardiogram (EKG) by using KardiaBand, an attachable sensor developed by medical technology company AliveCor. The device attaches to the strap of the Apple Watch and users are able to record…

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Remote programming for cochlear implants approved by FDA

The FDA has approved a remote programming system for patients with cochlear implants, removing the need for patients to visit specialised clinics to have their devices adjusted. The programming feature is for patients who have had their cochlear implant for more than six months and are comfortable with the programming process. The remote programming session…

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How are health apps affected by medical device rules?

First published in our sister title Medical Plastics News – Lorna Brazell and Piet Weinreich, Osborne Clarke examine the issue surrounding software and when it may or may not fall under medical device regulations. It is widely known that in some circumstances, software may fall within the category of medical device and so have to…

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