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.

DeviceTalks West: Expertise you need to know

textadimage Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm.

From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in their own right.

Read on to discover five example of medical device expertise to be had at DeviceTalks West, which runs Dec. 11–12 in Orange County, Calif.

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