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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.
Medtronic is relaunching its Harmony Transcatheter Pulmonary Valve (TPV) system after a March 2022 recall following six reports of a failure of the capsule at the end of the delivery catheter.
At the end of the surgery, the surgeon removes the device with the needles stored safely inside, eliminating the potential for needle loss inside the patient.