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AI Medical Device Use-Case Index

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Brainomix 360 Stroke

Brainomix
UK
Certification:
CE marked – Class IIa (EU MDR)

The Brainomix 360 Stroke stroke platform is a FDA-cleared and CE-marked collection of tools that use our state-of-the-art AI algorithms to support doctors by providing real-time interpretation of brain scans to help guide treatment and transfer decisions for stroke patients, allowing more patients to get the right treatment, in the right place, at the right time.

Our proprietary software can uniquely generate critical information from simple brain scans that can help expand patient access to life-saving stroke treatments by advancing the value of simple imaging.

VUNO Med®-BoneAge™

Maihub
South Korea
Certification:
CE marked (legacy MDD); EU-MDR not confirmed

VUNO Med®-BoneAge™ is an AI-based diagnostic support solution for bone age assessment, designed to analyze hand X-ray images in children under 19 years old. It uses deep learning trained on 18,940 left-hand radiographs to estimate bone age and provides three most likely candidates based on the Greulich-Pyle (GP) method, significantly reducing the time and variability associated with manual assessment.

Lunit INSIGHT MMG

Lunit
South Korea
Certification:
CE marked (EU MDR)

Lunit INSIGHT MMG (2D) mammography software supports earlier breast cancer detection, especially in dense breasts and interval cancers.

Designed for streamlined PACS and viewer integration, it delivers AI-driven insights during image review. This shortens reading time, supports single- and double-reading workflows, and helps address the shortage of breast imaging specialists in high-volume settings.

SkinVision

SkinVision
Netherlands
Certification:
CE marked – Class IIa (EU MDR)

SkinVision is a regulated medical service that takes control over your skin health to a new level. It expands your ability to self-examine your skin and elevates your knowledge when to act, how and why. It is designed to provide accurate and timely skin cancer detection, along with the most reliable personalised skin health advice and health path recommendation. At the centre of the service is the SkinVision app, which is a regulated medical device that merges AI technology with the expertise of skin health professionals and dermatologists. SkinVision is a service of choice whether you want to address your most immediate concerns, learn what steps you should take next, understand your skin risk profile and introduce the most intelligent skin health regime to your seasonal rhythm.

Paige Prostate Detect

Paige AI
USA
Certification:
FDA (US); CE-IVD in EU under IVDR – not MDR

Proven to significantly improve pathologist sensitivity and specificity in the diagnosis of prostate cancer with an average 70% reduction in detection errors in a cohort of 16 first-time users

GI Genius™ intelligent endoscopy module

Medtronic
USA
Certification:
CE marked (EU MDR)

The GI Genius™ intelligent endoscopy module is a computer-aided polyp detection system powered by AI to detect colorectal polyps through enhanced visualization during colonoscopy.

QP-Prostate

Quibim
Spain
Certification:
CE marked – Class IIa (EU MDR)

QP-Prostate introduces enhanced diagnostic capabilities, streamlining radiologists’ workflows by automatically ensuring compliance with PI-RADS v2.1 guidelines, accurately segmenting the prostate gland, and efficiently identifying suspicious lesions. These advancements enable radiologists to provide faster and more accurate assessments, directly improving patient care.

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