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Abbott Receives US Authorization For First 'Virtually Guided' At-Home Rapid Test

 
• By Marion Webb

Abbott plans to deliver 30 million BinaxNOW prescription, at-home rapid tests in the first quarter of 2021; 90 million more in the second quarter.

Quant antibody test

Abbott announced on 16 December that the US Food and Drug Administration has issued emergency use authorization for BinaxNOW COVID-19 Ag Card Home, its 'virtually guided' at-home COVID-19 antigen test. Users receive step-by-step instructions about the sample collection process and guidance in reading and understanding the results via an app.

Abbott said it will bring BinaxNOW to the patient’s home at a cost of $25 for testing and service via its telehealth partner eMed. This makes it the “most affordable...

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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.

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