Spectral AI Receives FDA Clearance for AI-Powered Burn Assessment System

Deepview HHF Training and Validation Study

Conditions : Burns; Burn Injury; Diagnostic Interventions : Device: DeepView AI System Sponsors : SpectralMD Not yet recruiting

IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy

IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who hav

An FDA for AI?

Are You Ready for Elsa? What the FDA’s Generative AI Inspection Tool Means for Clinical Data Teams

In June 2025, the U.S. Food and Drug Administration (FDA) launched the Electronic Language System Assistant (Elsa), a generative AI tool des

HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis

- FDA 510(k) Clearance (K253390) Validates AI-Based Classification of OSA, CSA, and MSA - Subtype-Specific Respiratory Event Analysis Improv

Automating Label Accuracy in Medical Imaging: A New Approach

A novel method uses deep learning to identify mislabeled medical images, enhancing dataset accuracy and model performance. This could revolu