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Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease

 
• By Eliza Slawther

Huma Therapeutics has secured the first ever EU regulatory approval for a “disease agnostic” class IIb medtech software platform. CEO Dan Vahdat tells Medtech Insight how the product can be configured to monitor patients with any condition.

Huma Therapeutics
• Source: Huma Therapeutics

UK-based Huma is the world’s first company to receive class IIb certification under the EU Medical Device Regulation for a disease agnostic Software as a Medical Device (SaMD) platform, it announced on 23 March. This certification means that the product can now be configured for use in any patient and for the management of any condition.

The monitoring platform, which was previously certified for use in the EU as a class I device in 2018 and...

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• By Brian Bossetta

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• By Ashley Yeo

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• By Natasha Barrow

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Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
• By Ashley Yeo

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More from Geography

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

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• By Sue Sutter

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• By Brian Bossetta

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