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Paige Secures Eighth CE Mark For Cancer Identification AI

 
• By Barnaby Pickering

The Memorial Sloan Kettering spin-out has received CE-IVD and UKCA marks for its artificial intelligence software designed to identify HER2 expression in biopsies.

Stained_Tissue
• Source: Shutterstock

Just over a month since its seventh CE mark for its prostate cancer biomarker suite, Paige AI has collected its eighth, this time for its HER2Complete software, the company announced on 23 June.

Paige's HER2Complete is the first CE-IVD and UKCA-marked AI tool designed to identify tumor tissue with HER2 (human epidermal growth...

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More from Approvals

Medicare Tricuspid Regurgitation Coverage Decision Big Win For Abbott

 
• By Brian Bossetta

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Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
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FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 
• By Brian Bossetta

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More from Policy & Regulation

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By Elizabeth Orr

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Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

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