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News We’re Watching: Skippack Medical Recall; $42M Verdict In Boston Sci Patent Battle; Nanoparticle Engineering Group Launched

 
• By Brian Bossetta, Hannah Daniel, and Elizabeth Orr

Three diagnostics that detect COVID-19 as well as the flu got regulatory authorization this week. Meanwhile, Skipjack’s COVID-19 test recall was designated class I; a new collaboration to promote nanoparticle engineering was launched; and an FDA guidance document discusses long-term safety for products used in newborns.

"News We're Watching" Feature Image
• Source: Medtech Insight

The US Food and Drug Administration has granted emergency use authorization for two new assays designed to detect both COVID-19 and Influenza: Becton Dickinson’s BD Respiratory Viral Panel for BD MAX System and LumiraDx UK’s LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay.

The BD diagnostic is authorized to detect the COVID-19 virus, SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) in nasopharyngeal and anterior nasal swab specimens. The LumiraDX test...

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More from Regulation

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

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.

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.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.