Paige Secures Eighth CE Mark For Cancer Identification AI

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approvals

South Korean Health Ministry Sees Benefits Of Pre-Regulatory Review

 
• By 

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.

Newborn Screening Tests Among FDA Classifications

 
• By 

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics

More from Policy & Regulation

Global Medtech Guidance Tracker: June 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By 

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.