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Pixium Sees Way Forward For Its Vision-Restoring Implants In A Tough Market

 
• By Barnaby Pickering

The company has just two quarters’ of cash remaining, but has also achieved major milestones towards the development and commercialization of its implant that hopes to restore vision in patients with age-related macular degeneration.  

The way forward for patients with macular degeneration may be clearer once Prima comes to market • Source: Shutterstock

Pixium Vision is making progress on an implant system for people with age-related macular degeneration.

The US Food and Drug Administration recently approved the first drug designed to combat age-related macular degeneration (AMD)

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More from Policy & Regulation

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

More from Medtech Insight

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

GE HealthCare Warns Of $500M Tariff Hit In 2025, Eyes Recovery in 2026

 
• By Shubham Singh

GE HealthCare anticipates most of the $0.85 EPS tariff impact will play out in the second half of 2025. Jay Saccaro, vice president and CFO, said the tariff-related burden is minimal in Q1 at about $10 million, rising to nearly $100 million in Q2 and then spiking to around $200 million each in Q3 and Q4.

Peerbridge Bets On At-Home Heart Monitoring With Rechargeable, Longer-Lasting ECG Patch

 
• By Marion Webb

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.