Endoscopy · Colonoscopy CADe

CADDIE

Olympus Corporation (Odin Medical Ltd.)

CEFDARCT

The first cloud-based CADe system cleared by the FDA and CE-marked under MDR, with a 7.3-percentage-point absolute ADR gain and a 93 % relative increase in large-adenoma detection in the 841-patient EAGLE randomised trial.

Performance Metrics

+7.3 ppADR IMPROVEMENTEAGLE RCT, n=841 (2025)
+93%LARGE ADENOMAS>10 mm, per colonoscopy
+230%SESSILE SERRATED LESIONSEAGLE RCT secondary endpoint
+57%NON-POLYPLOID ADENOMASEAGLE RCT secondary endpoint

Clinical Evidence

The EAGLE study (NCT05730192) was an eight-centre, four-country European RCT enrolling 841 screening and surveillance patients (417 CADe-arm, 424 standard-of-care arm). The primary endpoint — adenoma detection rate in the screening/surveillance population — showed a 7.3 percentage-point absolute improvement with CADDIE versus standard colonoscopy. Secondary endpoints demonstrated a 93 % relative increase in large (>10 mm) adenomas detected per colonoscopy, a 57 % relative increase in non-polyploid adenomas, and a 230 % relative increase in sessile serrated lesions (SSLs). No increase in unnecessary resections was observed. The paper was published in *npj Digital Medicine* (December 2025).

StudyDesignnSensitivitySpecificityAUCPublished
Kader R, Hassan C, Lanas Á, et al. (EAGLE Trial Investigators)
RCTRCT
841———npj Digital Medicine, Dec 2025

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Regulatory Approvals

CE
CADDIE

Class IIa

FDA
CADDIE CADe

K240044

Class II

Safety Record

No safety alerts or recalls on record.

No device recalls or FDA safety alerts specific to CADDIE have been identified as of the review date. The EAGLE trial reported no increase in unnecessary polypectomies, addressing a key concern regarding CADe-induced over-treatment. The system is limited to standard white-light endoscopy imaging; use outside that modality is not cleared.

Intended Use & Indications

CADDIE is indicated to assist qualified gastroenterologists in identifying and localising suspected colorectal polyps during standard white-light colonoscopy. The system analyses live video streamed to the cloud and returns real-time detection overlays; it is not intended to replace endoscopist judgement or to characterise lesion histology.