Artificial Eye Gets Expedited/Breakthrough Designation From US FDA
US FDA has admitted a Second Sight Medical device that the company says could help restore vision to many blind people to its Expedited Access Pathway for swifter review of groundbreaking products.
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'Breakthrough' Blueprint: US FDA Draft Guideline Outlines Revised Expedited Development Program
The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."
Second Sight Shows The Way
Second Sight secured FDA approval for the Argus II Retinal Prosthesis System in 2013 and followed it with an IPO, giving the company the capital necessary to expand the commercial launch of its system to restore the vision of patients blinded by retinitis pigmentosa while also developing a new system that might restore the vision of anyone who has lost their sight to disease. An interview with CEO Robert Greenberg, MD.
COVID-19 EUAs To Stay Active After Public Health Emergency Ends
Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.