News & Alerts

NIA Member Endomagnetics receives FDA Approval to begin Trials of nano-enabled Medical Device in US

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.

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