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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...

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FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

Barcelona’s S2 Xpeed Accelerates Hardware-Based Medtech Start-Ups From Prototype To Market

 
• By Marion Webb

Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.

Seonix Bio’s Newly Launched Saliva-Based Genetic Test Aims To Shed Light On Glaucoma Risk Assessment

 
• By Marion Webb

Seonix launched SightScore, the first clinical polygenic risk score test for glaucoma available in the US, and plans to introduce more genetic-based tests for eye conditions such as macular degeneration.

More from Device Area

Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

HistoSonics’ Edison System Gains Limited UK Access, While Awaiting CE Marking

 
• By Shubham Singh

While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.

J&J MedTech Launches KINCISE 2 Surgical Automated System In US

 
• By Natasha Barrow

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.