New Study Finds Rich Hospitals Got Ambient AI Scribes First, Raising Fears of a Widening Care Gap
When ambient AI documentation tools first rolled into hospital exam rooms a few years ago, the pitch was universal: give...
Year: 2026
PathAI Wins FDA Breakthrough Status for AI That Tackles Dermatopathology’s Coin-Flip Diagnoses
PathAI announced on March 3, 2026 that it had received FDA Breakthrough Device Designation for PathAssist Derm, an AI tool...
Leica Biosystems Wins Industry-First FDA Clearance for AI That Catches Pathology Lab Errors Before They Reach Doctors
Leica Biosystems announced on August 11, 2026 a batch of new FDA 510(k) clearances for its digital pathology portfolio, headlined...
AI Tool That Reads Medical Records to Flag Hidden Cancer Risk Seeks First-of-Its-Kind FDA Clearance
A British AI company called C the Signs is pursuing FDA De Novo clearance for a tool that scans a...
Alibaba’s Pancreatic Cancer AI Becomes First Chinese-Built Model to Win FDA Breakthrough Status
An AI model developed by Alibaba's DAMO Academy, known as PANDA, has received Breakthrough Device Designation from the FDA for...
Artera Wins FDA Clearance for AI Tool That Predicts Which Breast Cancer Patients Need Aggressive Treatment
Artera received U.S. FDA clearance on May 6, 2026 for ArteraAI Breast, a digital pathology tool the company says is...
AI Tool Catches Prostate Cancers Pathologists Missed in 13% of Cases, FDA Clearance Data Shows
Ibex Medical Analytics has received FDA 510(k) clearance for Ibex Prostate Detect, an AI-powered digital pathology tool designed to help...
‘Claire’ Becomes First FDA-Approved AI Imaging Device to Guide Breast Cancer Surgery in Real Time
Perimeter Medical Imaging AI announced on March 3, 2026 that its device, known as Claire, received FDA premarket approval, making...
Paige’s AI Pathology Tool Wins FDA Breakthrough Status for Spotting Cancer Across 40 Organ Types
Digital pathology company Paige has secured FDA Breakthrough Device Designation for Paige PanCancer Detect, an artificial intelligence system designed to...
FDA Clears First AI Medical Device With a Patient-Facing Chatbot, Opening a New Regulatory Lane
For years, the artificial intelligence tools cleared by the Food and Drug Administration have almost all worked behind the scenes,...
