The FDA has given the green light to over-the-counter sales of Abbott’s Lingo blood glucose monitoring device, which is intended for use by healthy people who want to track the crucial biomarker.
The number of over-the-counter blood glucose monitors authorized for market in the US just doubled with the 29 May clearance of Abbott’s Lingo.
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A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
