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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
Health plan operations, utilization management, payment integrity
No FDA clearance or De Novo authorization; operates as health plan operations SaaS software, not an FDA-regulated AI medical device. HITRUST CSF certified, NCQA certified, URAC certified, HIPAA compliant, CMS-0057-F compliant (US).
Evidence Tiers
Company-reported case studies and internal surveys only; no independent peer-reviewed RCTs of Cohere Health's platform published as of Q2 2026
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.
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.
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.
A field-level look at how AI tools are being deployed across hospitals, health systems, and outpatient networks — covering workflow integration patterns, documented outcomes, adoption friction, and failure modes that controlled studies rarely capture.
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.
A structured overview of how AI is authorized for medical use in the US, covering the FDA clearance pathways, what device categories dominate the registry, and what clinicians and procurement staff need to understand before acting on a clearance status.
A factual, structured overview of the companies building and deploying AI for clinical and operational healthcare use — organized by application area, FDA clearance status, funding stage, and deployment evidence as of Q2 2026.
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.
A structured overview of how AI/ML-enabled medical devices reach FDA authorization in the United States — covering the three clearance pathways, which clinical specialties dominate the cleared device landscape, and what FDA clearance does and does not tell you about clinical performance.
A factual profile of Aidoc, one of the most FDA-cleared radiology AI companies in the US market, covering its device portfolio, clearance pathways, clinical deployment history, funding status, and known evidence base as of mid-2026.
A factual, structured overview of the major companies developing AI for clinical and operational healthcare use — covering primary focus areas, FDA clearance status, funding stage, and the evidence dimensions that matter for professional evaluation.
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.
A field-level review of how artificial intelligence is being deployed across clinical environments — covering integration methods, operational outcomes, documented failure modes, and what separates successful implementations from stalled ones.
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.
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.
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.
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.
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.
Cohere Unify
Health plan operations, utilization management, payment integrityNo FDA clearance or De Novo authorization; operates as health plan operations SaaS software, not an FDA-regulated AI medical device. HITRUST CSF certified, NCQA certified, URAC certified, HIPAA compliant, CMS-0057-F compliant (US).Company-reported case studies and internal surveys only; no independent peer-reviewed RCTs of Cohere Health's platform published as of Q2 2026
Use Case: Prior authorization automation, inpatient authorization review, payment integrity audit, and claims-to-authorization reconciliation for health plans
A structured, evidence-anchored intelligence profile of Cohere Health covering its founding history, $200M funding trajectory, Cohere Unify platform architecture, full 2025–2026 product suite, CMS-0057-F compliance posture, deployment outcomes with evidence quality assessment, and known limitations — designed for health plan administrators, health IT decision-makers, and clinical researchers evaluating AI-driven utilization management.
Stage: Series C (May 2025, $90M led by Temasek); total disclosed funding approximately $200M; private company
Profile verified:
Cohere Unify
Utilization Management / Payment IntegrityHITRUST-certified, CMS-0057-F compliantWhite paper only
Use Case: Prior authorization automation, payment integrity, acute inpatient utilization management, and clinical policy management
This article examines Cohere Health's strategic expansion from outpatient prior authorization into acute inpatient utilization management, payment integrity, and clinical policy management, powered by its Cohere Unify AI engine and the September 2025 acquisition of ZignaAI. Written for healthcare investment analysts, health system strategists, and health IT researchers, the analysis focuses on the platform economics, competitive implications, and performance data that define Cohere's evolution into an end-to-end clinical-financial intelligence platform.
