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.
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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The 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.