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The FDA’s focus on encouraging devicemakers who want to market Class III devices that could benefit patients with rare diseases or conditions has led to the humanitarian device exemption (HDE) for these very small markets.
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.