Shots:
- AI Medical Technology has reported the CE mark approval of Dermalyser for melanoma detection; commercialization to begin in 2025
- Dermalyser was validated in AI-DSMM study across 36 Swedish centers, where it analyzed 253 suspicious lesions in 228 pts, identifying 21 melanomas (11 as thin invasive & 10 as in situ). It also achieved AUROC 0.960, with 95.2% sensitivity & 84.5% specificity, plus 100% sensitivity & 92.6% specificity for invasive cases compared to dermatologists (AUROC 0.85) & general practitioners (AUROC 0.70)
- Dermalyser is a stand-alone medical device software designed for smartphones attached to an AI-powered dermatoscope, with an aim to enter US market via FDA 510(k) clearance in 2027
Ref: Prnewswire | Image: AI Medical Technology| Press Release
Related News:- ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain
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