1. Medtech Insight
  2. >>Device Area
  3. >>Ophthalmology

Artificial Eye Gets Expedited/Breakthrough Designation From US FDA

 
• By Elizabeth Orr

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.

[Editors' note: Check out Medtech Insight's US Expedited Access Tracker for details on all products for which the sponsors have publicly disclosed acceptance into the EAP/Breakthrough program.]

Second Sight Medical Products Inc. announced Nov. 8 that US FDA has accepted its Orion Cortical Visual Prosthesis System...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Ophthalmology

More from Device Area

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By Elizabeth Orr

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

Philips Deals Itself A Strong Hand In POCUS Stakes

 
• By Ashley Yeo

Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 
• By Natasha Barrow

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.