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AI Health News — Media Hub.

Not a news feed. A curated intelligence platform on the moves that shape clinical AI worldwide.

FDA Clearance
Radiology AI

Aidoc's CARE1™ becomes the first foundation-model clinical AI cleared by the FDA

In February 2025, the FDA cleared Aidoc's CARE1 — the first foundation-model-powered clinical AI to receive U.S. authorization.

AidocFeb 2025
Breakthrough
Digital Pathology

Paige's PanCancer Detect named FDA Breakthrough Device

April 2025: FDA Breakthrough Device designation for the first AI tool detecting common & rare cancers across tissues.

Paige · Tempus AIApr 2025
Clinical RWE
Health Data & Predictive

Viz.ai cuts acute stroke evaluation time by ~66 minutes across 1,600+ hospitals

ISC 2025 evidence across six new clinical studies on the Viz Neuro Suite.

Viz.ai2025
CE Mark
Digital Pathology

PathAI's AISight® receives CE mark in EU

A regulatory unlock for European clinical deployment under MDR.

PathAI2025
M&A
Oncology AI

Tempus AI acquires Paige to consolidate multimodal precision medicine

~$81.25M deal bringing genomics + imaging + pathology under one roof.

Tempus AI ⇆ Paige2025
FDA Clearance
Oncology AI

Tempus xT CDx national launch — RNA NGS in vitro diagnostic

ADLT-granted, $4,500-per-test reimbursement — AI-enabled oncology diagnostics matures.

Tempus AI2025
FDA 510(k)
Radiology AI

Tempus Pixel cardiac imaging — updated FDA 510(k)

Cardiac imaging + ECG-Low EF software both cleared.

Tempus AI2025
Market Data
FDA & CE Approvals

FDA crosses 1,450 cumulative AI medical device authorizations

Industry milestone — 295 new authorizations in 2025 alone, 76% radiology.

FDA · CDRHDec 2025
Partnership
Health Data & Predictive

Tempus AI & NYU Langone — multi-year cancer evolution study

Longitudinal RWE work that improves real treatment decisions.

Tempus AI ⇆ NYU Langone2025
Regulation
FDA & CE Approvals

Predetermined Change Control Plans (PCCPs) become mainstream

Formal authorization for models to evolve post-clearance.

FDA · CDRH2025
Validation
Radiology AI

Q4 2025: 55 of 72 FDA AI clearances were radiology

Radiology remains the path of least resistance for new AI medtech.

FDA AI/ML listQ4 2025
Wound Care
Wound Tech

DeepView wound assessment AI gains clinical traction

Multi-spectral imaging predicting wound healing trajectory.

Spectral AI2025

Curated by RauMed Intelligence.