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Company & Product Profiles

Structured profiles of healthcare AI companies and their clinical products, covering what the product does, the clinical specialty and use case, FDA/CE regulatory status, EHR integrations, evidence base quality, funding stage, and known deployment context. Profiles are factual and source-attributed — not promotional. This group serves health system administrators, CIOs, CMIOs, and procurement teams evaluating AI vendors, as well as researchers and investors tracking the industry landscape. Profiles are distinguished from editorial analysis: they present structured facts, not recommendations. Excludes unverified claims and vendor-supplied performance data presented without independent corroboration. Links to relevant regulatory records, research evidence entries, and clinical application analyses.

Clinical Specialties

  • Radiology, Cardiology, Pathology, Ophthalmology, Gastroenterology

Company & Product Profile Entries

  • iCAD ProFound AI Mammography: FDA Clearance History and Device Record

    A structured technology-profile reference consolidating iCAD's complete multi-generation FDA clearance record for its ProFound AI / ProFound Detection DBT mammography system — covering K-numbers, decision dates, product codes, AI architecture, reported clinical performance per version, and current corporate status under DeepHealth/RadNet — for radiologists, procurement teams, and policy professionals evaluating AI-powered mammography software.

  • Caption AI Cardiac Ultrasound: FDA Authorization History, Clinical Validation, and Technology Profile

    A structured technology profile of Caption AI, the AI-guided cardiac ultrasound platform developed by Caption Health (now a GE HealthCare subsidiary), covering its complete FDA authorization record from the landmark 2020 De Novo through the 2025 510(k) clearance, the clinical validation evidence behind its non-expert use design, and its current deployment on the Vscan Air SL handheld system — for cardiologists, procurement teams, and regulatory professionals evaluating the platform.

  • Abridge: Company Profile for the Leading Enterprise Ambient AI Documentation Platform

    A structured, evidence-anchored profile of Abridge — covering its founding, funding history, product architecture, deployment scale, peer-reviewed clinical evidence, FDA regulatory status, and competitive position as of mid-2026 — for clinicians, health system procurement teams, and policy professionals evaluating ambient AI documentation tools.

  • AI Companies in Healthcare: A Structured Landscape Overview

    A factual, sourced overview of the major AI companies operating in healthcare as of mid-2026, organized by application domain, FDA clearance status, and company stage — written for clinicians, procurement staff, and policy professionals who need orientation, not rankings.

  • Radiology, Cardiology, Pathology, Ophthalmology, Gastroenterology

    AI in the Medical Field: How FDA-Cleared Devices Actually Work

    A structured reference overview of how AI is deployed in the medical field through FDA-authorized devices — covering clearance pathways, clinical specialties, intended use definitions, and what regulatory authorization does and does not mean for clinical practice.

  • Radiology, Cardiology, Pathology, Ophthalmology, Gastroenterology

    Artificial Intelligence in Health: How FDA-Cleared AI Devices Actually Work

    A structured reference covering how artificial intelligence in health is regulated through FDA authorization pathways, what clearance actually means in clinical practice, and how to evaluate device records for real-world use.

  • Healthcare AI Companies: A Structured Landscape Overview

    A factual, non-promotional overview of the major categories of companies developing AI for healthcare — covering imaging AI, ambient documentation, clinical decision support, genomics, and drug discovery — with notes on FDA clearance status, funding stage, and evidence posture.

  • IDx-DR (DEN180001): FDA De Novo Authorization Record for the First Autonomous AI Diagnostic System

    A structured device registry record for IDx-DR, the first autonomous AI diagnostic system authorized by FDA in any field of medicine — documenting its De Novo classification (DEN180001, April 11, 2018), intended use, pivotal clinical trial evidence, algorithm architecture, predicate role for subsequent DR AI devices, and post-market evolution into LumineticsCore. Intended for clinicians verifying clearance status, regulatory professionals tracking authorization history, and procurement staff evaluating FDA-cleared diabetic retinopathy screening devices.

  • Paige Prostate (DEN200080): FDA De Novo Authorization Record — First AI Device in Computational Pathology

    A structured regulatory record for Paige Prostate (DEN200080), the first AI-based device to receive FDA marketing authorization for computational pathology, covering its De Novo pathway, clinical evidence basis, performance metrics, equity considerations, and post-market status including the 2025 Tempus AI acquisition — intended for clinicians, procurement staff, and regulatory professionals verifying the authorization before adoption or comparison.

  • Tempus AI Company Profile: Genomics, FDA Regulatory Record, and Clinical Evidence in Precision Oncology

    A structured single-company record profiling Tempus AI (NASDAQ: TEM) as a vertically integrated precision medicine company — covering its FDA-authorized genomic diagnostics, AI clinical decision support platform, business model, peer-reviewed evidence base, and known limitations including active class-action litigation over patient genetic data privacy. Intended for clinicians evaluating AI-enabled genomic diagnostics, procurement staff, oncology researchers, and regulatory professionals tracking NGS and AI diagnostic authorizations as of Q2 2026.

  • Viz.ai Stroke AI — FDA Device Record: K192872

    A structured registry record for Viz.ai's FDA-cleared stroke AI device (510(k) K192872), covering its authorized intended use, regulatory pathway, specialty panel, and the clinical context practitioners need to evaluate its role in acute stroke workflows.