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Tool For Evaluating LASIK Outcomes Gets FDA Qualification

 
• By Brian Bossetta

The US FDA has qualified a tool used to assess patient outcomes of LASIK surgery as scientifically valid. The qualification aims to support the agency’s pre- and post-market regulatory decisions and aid manufacturers in the development of devices for the procedure.

Patient having LASIK surgery.
PATIENT HAVING LASIK EYE SURGERY. • Source: Alamy

The US Food and Drug Administration has qualified the Patient-Reported Outcomes with LASIK Symptoms and Satisfaction – or PROWL-SS – as a scientifically valid tool. The agency qualified PROWL-SS through its Medical Device Development Tools (MDDT) program, which was designed to expedite the approval process for devices that incorporate emerging technology.

LASIK (laser-assisted in situ keratomileusis) is one of the most common elective surgeries in the US. An estimated 10 million Americans have had LASIK since it was first approved by...

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Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
• By Brian Bossetta

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

More from Policy & Regulation

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.