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Innovative Diagnostic For Babies Wins NICE Early Value Assessment Pilot Backing

 
• By Eliza Slawther

An innovative genetic test that can detect which babies are likely to develop deafness if treated with a common antibiotic is set to receive conditional funding in the UK under NICE’s rapid evaluation pilot scheme.

GeneticTest
• Source: Shutterstock

The role of innovative genetic testing as a companion to medical treatment is often linked to the prediction of how effective a certain treatment will be. However, such tests can also determine whether giving a patient a drug could result in a life-altering reaction, as is the case with commonly prescribed antibiotic gentamicin.

In new draft guidance issued as part of a medtech reimbursement pilot scheme, the UK’s National Institute of health and Care Excellence (NICE) recommended the funding of the genedrive...

EVA Timeline

In August 2022, NICE made its first EVA draft decision. AliveCor’s KardiaMobile 6L, a portable ECG that wirelessly records and transmits data,...

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More from United Kingdom

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.

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.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 
• By Natasha Barrow

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.

LSX Europe: Women’s Health Education Is The Key For Unlocking VC Investment

 
• By Natasha Barrow

Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.

More from Europe

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.

23andMe Purchase Will Let Regeneron Scale Drug Development

 
• By Alaric DeArment

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.