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The FDA has granted de novo approval to Neuromod’s Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.
Abbott’s newly FDA-cleared blood test is the first commercially available diagnostic that assesses whether a patient with a mild traumatic brain injury (mTBI) — commonly known as a concussion — needs further evaluation with a computed tomography (CT) scan.
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.