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RauMed Intelligence.

A continuously updated, curated read of where medical AI is going.

Watchlist

The companies we follow closely.

A non-exhaustive map of the medical AI firms whose products, clearances and clinical evidence we track.

Radiology

Aidoc

Foundation-model-powered clinical AI. CARE1™ cleared by FDA, Feb 2025.

HQ · New York / Tel Aviv
Oncology · Multimodal

Tempus AI

Multimodal precision medicine. FDA clearances across xR IVD, Pixel, ECG-Low EF.

HQ · Chicago
Digital Pathology

Paige (Tempus AI)

First AI pathology product with FDA de novo. PanCancer Detect — FDA Breakthrough, Apr 2025.

HQ · New York
Digital Pathology

PathAI

AISight® digital pathology suite. CE mark 2025, Quest Diagnostics partnership.

HQ · Boston
Stroke AI

Viz.ai

Stroke care coordination across 1,600+ hospitals. Multiple ISC 2025 validations.

HQ · San Francisco
Radiology

Qure.ai

Chest X-ray, head CT, stroke and TB AI. Deployed across emerging markets.

HQ · Mumbai / New York
Cancer Screening

Lunit

INSIGHT MMG, CXR and SCOPE IO. Strong clinical evidence in Europe and Asia.

HQ · Seoul
Wound Care

Spectral AI

DeepView wound assessment — predicts healing trajectory.

HQ · Dallas
Imaging Platform

Nanox

Stationary X-ray + AI population screening modules.

HQ · Israel / NY
FDA & CE Tracker

Signals from the regulatory front.

Recent and notable regulatory events in healthcare AI.

Mar 2026
24 new AI/ML SaMD clearances in a single month One clearance every 31 hours.
FDA · multi-vendor
FDA
Dec 2025
FDA AI device list surpasses 1,000 radiology authorizations 76% of all AI-enabled clearances are radiology.
FDA · CDRH
Milestone
Apr 2025
Paige PanCancer Detect — FDA Breakthrough Device First AI to detect common & rare cancers across tissues.
Paige · digital pathology
FDA Breakthrough
2025
PathAI AISight® receives CE mark in EU Digital pathology platform under MDR.
PathAI · Boston
CE Mark
2025
Tempus AI — Pixel cardiac imaging FDA 510(k) ECG-Low EF software also cleared.
Tempus AI
FDA 510(k)
2025
Tempus AI acquires Paige (~$81.25M) Multimodal precision medicine + digital pathology.
Tempus AI ⇆ Paige
M&A
Feb 2025
Aidoc CARE1™ — first foundation-model clinical AI cleared by FDA Foundation models cross into authorized clinical software.
Aidoc
FDA Clearance
ISC 2025
Viz.ai — six new clinical studies on Neuro Suite Real-world stroke evaluation time reduction.
Viz.ai
Clinical Validation

Tracker is curated by RauMed Intelligence. Last updated: May 2026.

Market overview

The shape of medical AI in 2026.

A few data points that shape our strategic priorities.

1,451+
Cumulative FDA-cleared AI devices (end 2025)
76%
of AI clearances in radiology
120
GE HealthCare AI radiology authorizations
10%
of 2025 clearances now use PCCPs

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