Artificial Intelligence

Avant Technologies and Ainnova Request FDA Pre-Submission Meeting for VisionAI Platform

Companies seek guidance on clinical trial design for AI-driven diabetic retinopathy detection, aiming for 510(k) clearance to enter U.S. market....

FDA Clears Clarius Prostate AI for Handheld Ultrasound-Based Prostate Assessment

First AI-powered tool for real-time prostate volume and PSA density measurement aims to streamline urologic diagnostics in primary care settings. ...

Simplex Quantum and University of Tokyo Introduce AI-Based Heart Failure Monitoring System

The new HF-index enables accurate, on-demand heart failure severity tracking using single-lead ECG data from wearable devices....

Cortechs.ai Secures Health Canada Approval for AI Imaging Expansion

The regulatory milestone paves the way for broader adoption of its neuroimaging solutions across North America....

BD Launches Next-Gen Hemodynamic Monitoring with AI-Powered Decision Support in the U.S.

New system enhances real-time patient assessment, enabling clinicians to make faster, data-driven decisions. ...

Imidex’s FDA-Cleared Lung Cancer Detection Algorithm Acquired – U.S.

The sale marks a pivotal move in advancing early-stage lung cancer diagnosis through AI-powered radiology solutions....

Taiwan: JelloX Collaborates to Advance 3D Pathology for HER2+ Breast Cancer Treatment

New research partnership promises enhanced precision in diagnosing and targeting HER2-expressing breast cancers....

Subtle Medical & Strategic Radiology Partner in the U.S. to Expand Access to SubtleELITE™ AI Imaging Suite

The collaboration aims to enhance diagnostic imaging workflows by bringing advanced AI-powered imaging enhancements to more radiology practices nationwide....

Optellum & Bristol Myers Squibb Partner to Advance Early Lung Cancer Detection with AI

Rapidly growing lung health company aims to redefine early diagnosis and precision lung cancer care using multi-modal artificial intelligence (AI)....

Eko Health Launches AI Stethoscope Platform in the UK

Clinicians across the United Kingdom can now access Eko's advanced digital stethoscopes, auscultation accessories, and AI-supported tools via EkoHealth.com and Amazon UK....