Explore Solutions | CHAI Registry

ClinicalKey AI

ElsevierGeneral Availability

ClinicalKey AI is a conversational clinical decision support tool built on Retrieval-Augmented Generation (RAG) technology. The system is designed to help physicians at the point of care quickly obtain reliable, evidence-based answers to clinical questions. ClinicalKey AI uses Elsevier's trusted clinical content corpus — including Clinical Overviews, Drug Monographs, and peer-reviewed journal content — as its grounding knowledge base. It employs a LangGraph-based orchestration framework with pluggable RAG components, citation validation, query interpretation, multi-language support, and guardrails for out-of-scope or toxic queries. The system is intended to assist clinical decision-making, not replace it; all responses include citations, and clinicians are expected to apply professional judgment.

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Nabla Ambient AI

NablaPublished Commercial

Nabla is an ambient AI solution delivering real-time documentation of clinical encounters and medical dictation within structured formats by specialty. Key capabilities include: - Real-time ambient documentation automatically generates structured clinical notes - Supports 55+ specialties including primary care, emergency medicine, behavioral health, pediatrics, OB/GYN - Personalized workflows: customizable templates, personal dictionaries, and adaptive note personalization that learns from clinician edits over time - Multilingual support: enables bilingual patient encounter and generates patient instructions in over 35 languages - EHR integration supports bi-directional integration, pulling demographic and clinical data while pushing structured notes, patient instructions, vitals and problem lists

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iBPM.ai

iBPM, LLCProduction - No FDA clearance required

The iBPM Platform is an AI-enabled behavioral health and Health-Related Social Needs (HRSN) analytics platform that transforms unstructured clinical documentation into structured, reviewable insights. The platform supports care coordination, population health management, quality improvement, disparity analysis, operational decision-making, and Geographic Behavioral Health and HRSN Analytics through dashboards, trend analysis, heatmaps, bubble charts, and geographic visualizations.

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Solution Snapshot

Intended use

The iBPM Platform is an AI-enabled behavioral health and Health-Related Social Needs (HRSN) analytics platform that tra…

Category / care setting

AI Ambient Scribes · Emergency Department

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Regulatory clearance

Not applicable - Not intended as a medical device. The platform provides analytics and decision-support capabilities and is not intended to diagnose, treat, cure, or prevent disease

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Canary Speech Vocal Biomarker Model for Cognitive Health

Canary SpeechProduction

Canary Speech’s Cognitive Health model provides a cutting-edge standardized instrument designed to assist healthcare professionals in the analysis of vocal biomarkers that provide clinical decision support for Mild Cognitive Impairment and Alzheimer’s Disease in patients aged 50 and older. Our software utilizes an artificial intelligence algorithm to analyze speech patterns, providing clinicians actionable insights for early detection and ongoing management. Built for seamless integration, it functions as a clinical decision support tool within digital health workflows. Ultimately, clinicians are responsible for the diagnosis of Mild Cognitive Impairment and Alzheimer’s Disease per the standard of care.

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Solution Snapshot

Intended use

Canary Speech’s Cognitive Health model provides a cutting-edge standardized instrument designed to assist healthcare pr…

Category / care setting

AI Imaging · Emergency Department

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Regulatory clearance

HIPAA compliant, HITRUST E-1 Certified, ISO/IEC 27001:2022 and 42001:2023 Certified

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Canary Speech Vocal Biomarker Model for Behavioral Health

Canary SpeechProduction

Canary Speech’s Behavioral Health model is a standardized instrument that provides clinical decision support to screen for Major Depressive Disorder and Generalized Anxiety Disorder in patients aged 18 and older. Our software utilizes an artificial intelligence algorithm to analyze speech patterns, providing clinicians with vocal biomarkers that provide actionable insights for early detection and ongoing management. Built for seamless integration, it functions within digital health workflows on any smart device. Ultimately, clinicians are responsible for the diagnosis of Major Depressive Disorder and Generalized Anxiety Disorder per the standard of care.

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Solution Snapshot

Intended use

Canary Speech’s Behavioral Health model is a standardized instrument that provides clinical decision support to screen…

Category / care setting

AI Imaging · Emergency Department

Model Type

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Regulatory clearance

HIPAA compliant, HITRUST E-1 Certified, ISO/IEC 27001:2022 and 42001:2023 Certified

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Rad AI Reporting

Rad AICommercially Available

Rad AI Reporting is an advanced radiology reporting platform designed to streamline the reporting process for radiologists. By leveraging generative AI technology, it enhances existing workflows by allowing users to dictate reports more efficiently while integrating seamlessly with their current systems and templates. The platform supports a range of functionalities, including real-time dictation, automatic incorporation of findings into structured reports, automatic generation of the impressions, and features that significantly reduce the time spent on follow-up exams. There are currently three unique generative AI features as part of Rad AI Reporting: Omni Box: enables radiologists to focus on imaging interpretations without constantly referring back to reporting screens, thus boosting productivity and reducing burnoutfrom repetitive transcription. Omni Unchanged: carries over prior findings to the current report, allowing radiologists to dictate only new findings or changes, saving further time and effort. Omni Impressions: automates the generation of the impressions section in radiology reports and automates the incorporation of guideline recommendations. (Also sold as a standalone solution as Rad AI Impressions – and has its own CHAI model card.)

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BriefCase-Triage for Central PE

AidocFDA Cleared, Commercial (K232751)

The Central PE algorithm is a radiological computer-aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of Central Pulmonary Embolism (Central PE). BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected Central PE findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of The Central PE algorithm are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

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Solution Snapshot

Intended use

The Central PE algorithm is a radiological computer-aided triage and notification software indicated for use in the ana…

Category / care setting

AI Imaging · Inpatient / Hospital

Model Type

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Regulatory clearance

Please find attached the CPE-01 [510(k) summary](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232751.pdf).

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BriefCase-Triage for Incidental Pulmonary Embolism

AidocFDA Cleared, Commercial (K250248) + kbis

Incidental Pulmonary Embolism is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (iPE) pathologies. The device is intended to be used on single energy exams only. BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of the Incidental Pulmonary Embolism are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

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Solution Snapshot

Intended use

Incidental Pulmonary Embolism is a radiological computer aided triage and notification software indicated for use in th…

Category / care setting

AI Imaging · Inpatient / Hospital

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Regulatory clearance

Please find attached the iPE-03-RT [510(k) summary](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250248). Add more data

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Rad AI Impressions

Rad AIProduction

Rad AI Impressions is a product that automates the generation of the impressions section in radiology reports, potentially enhancing radiologists' productivity and reducing burnout. It uses generative AI-based models to produce personalized impressions that match each radiologist's style and language. Rad AI Impressions also automates the incorporation of guideline recommendations, streamlining workflows and allowing radiologists to focus more on patient care. The model currently processes approximately 5 million reports each month, spanning over 200 health systems and radiology practices across the United States and Canada.

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OrbDoc Voice-to-SOAP Documentation System

OrbDocCommercial

The OrbDoc system is a voice-first, AI-powered clinical documentation platform that transforms how healthcare providers capture and utilize patient care information. The system processes voice recordings of doctor-patient conversations or physician dictations and converts them into structured clinical documentation with sophisticated medical context understanding. Beyond basic documentation, OrbDoc provides timeline visualization of patient journeys, progressive discharge documentation that evolves with care, advanced medication reconciliation, and automated billing support through CPT code generation. The system significantly reduces documentation time, enhances clinical workflow efficiency, optimizes revenue capture, and helps facilities improve care coordination to reduce readmission risks. Designed to work seamlessly across various healthcare settings including community health centers and rural facilities, OrbDoc integrates with major EHR systems and functions even in environments with limited connectivity.

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BriefCase-Triage for Vessel Occlusion

AidocFDA Cleared, Commercial (K220709)

The Vessel Occlusion solution is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of complete Large Vessel Occlusion (LVO) - MCA-M1, PCA-P1, ACA-A1, ICA, Basilar; and Medium Vessel Occlusions (MeVO) - MCA-M2, MCA-proximal M3, PCA-P2, PCA-proximal P3, ACA-A2, ACA-proximal A3, and Vertebral-V4. The Vessel Occlusion solution uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of The Vessel Occlusion solution are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Details

Solution Snapshot

Intended use

The Vessel Occlusion solution is a radiological computer aided triage and notification software indicated for use in th…

Category / care setting

AI Imaging · Inpatient / Hospital

Model Type

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Regulatory clearance

Please find attached the VO-01 [510(k) summary](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220709).

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