FDA puts Second Sight Medical’s next-gen Orion ‘bionic eye’ on the fast track


Second SightSecond Sight Medical (NSDQ:EYES) said today that the FDA put its Orion “bionic eye” on the fast track to approval.

The Orion device is a cortical visual prosthesis that uses a camera and a brain implant to bypass the optic nerve in visually impaired patients. The federal safety watchdog put the device on its expedited access pathway, giving Sylmar, Calif.-based Second Sight priority review, greater interactive review for both its investigational device exemption and pre-market approval bids, plus more emphasis on post-market studies rather than pre-market clinical work. The FDA will also assign a cross-disciplinary case manager for the Orion review.

Get the full story on our sister site MassDevice.

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