NIA Member Endomagnetics has announced that it ‘has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA)’ for two of its medical devices, the SentiMag® and the Sienna+®. This approval allows the company ‘to initiate a pivotal [multisite] clinical trial to evaluate the effectiveness of’ the devices.
The trial is expected to begin in January 2015, and will collect ‘data to support the future submission of a premarket approval application to the FDA’ for the devices. The company is hoping to have full approval by mid-2016.
These devices are only the second nanoparticle-enabled products to receive IDE approval from the FDA.
Follow this link to learn more about NIA Member Endomagnetics.