Nemaura Medical has received approval from the Saudi Food and Drug Authority (SFDA) for its non-invasive wearable glucose sensor, sugarBEAT.
This approval follows more than a year of partnership with the SFDA through the company’s licensee in the Middle East, TPMENA, from which Nemaura previously received a provisional purchase order for 1.7 million sensors and 17,000 devices.
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The company will now work with TPMENA to start fulfilling this purchase order.
sugarBEAT, an approved Class IIb medical device with a CE mark, offers practical insights from continuous glucose monitoring and daily glucose trends.
These insights can support individuals dealing with diabetes and pre-diabetes in enhancing their diabetes management, potentially reversing its effects and even preventing its onset.
Nemaura has filed a premarket approval application (PMA) with the US Food and Drug Administration (FDA) for this flexible continuous glucose monitor device.
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By GlobalDataThe company is also currently commercialising proBEAT, a general wellness offering within the BEAT diabetes programme.
It integrates artificial intelligence (AI)-processed non-invasive glucose information with a digital healthcare subscription service. The combination is currently in pilot studies.
Furthermore, Nemaura has commenced a beta study of Miboko, a programme that utilises a non-invasive glucose sensor and an AI mobile app to assist users in comprehending the effects of specific foods and lifestyle choices on their metabolic health and well-being.
