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The FDA has cleared the Abbott FreeStyle Libre 2 and FreeStyle Libre3 continuous glucose monitoring (CGM) sensors to be integrated with automated insulin delivery systems (AID) which automatically adjusts and administers insulin based on real-time blood glucose data.
The suit’s ability to retrain corrective movement patterns without injury or exhaustion allows the patient to achieve a freedom of performance that is otherwise unattainable.
Neuro20 Technologies has received FDA clearance for its wearable Neuro20 PRO suit that contracts muscles to help correct habits that were formed in response to old injuries.
Israel-based Theranica Bio-Electronics’ Nerivio remote electrical neuromodulation (REN) device can now be used as a preventive treatment for migraine, having received an expansion of its de novo marketing clearance the FDA granted in 2019 for acute migraine treatment.
The FDA’s process for bringing devices to market starts with a device’s risk classification and moves next to the level of controls placed on the device — not only for approval purposes but also for manufacturing, labeling, packaging and other activities that are monitored throughout a product’s lifecycle for enforcement purposes.