AI-Enabled Medical Devices & Diagnostics

AI-enabled devices and standalone diagnostic systems used in direct patient care.

These vendors build AI-enabled medical devices and standalone diagnostic systems used directly in patient care, such as point-of-care imaging devices and autonomous diagnostic software.

Vendors (3)

Sort the comparison by vendor or verification date. Product scope and regulatory status can change, so confirm the exact module, intended use, version, and deployment terms with the vendor and the applicable regulator.
Butterfly Network Point-of-care ultrasound acquisition and workflow Butterfly handheld ultrasound and connected imaging platform Verify the exact product, version, intended use, submission number, and authorization record in official FDA databases Clinical performance, ungradable or failure rates, external and prospective validation, usability, subgroups, and workflow outcomes Device connectivity, worklist, PACS, EHR, reporting, identity, network, and result routing as applicable Device, software, cloud service, or combined workflow; confirm hardware, consumables, sites, users, and service model 2026-09-26
Digital Diagnostics (IDx-DR) Autonomous diabetic retinopathy detection at the point of care LumineticsCore, formerly IDx-DR, autonomous diagnostic system LumineticsCore, originally authorized as IDx-DR, received FDA De Novo authorization; verify the current system, labeling, and deployment requirements Clinical performance, ungradable or failure rates, external and prospective validation, usability, subgroups, and workflow outcomes Device connectivity, worklist, PACS, EHR, reporting, identity, network, and result routing as applicable Device, software, cloud service, or combined workflow; confirm hardware, consumables, sites, users, and service model 2026-09-26
Caption Health AI-guided cardiac ultrasound acquisition Caption AI ultrasound acquisition guidance within GE HealthCare offerings Verify the exact product, version, intended use, submission number, and authorization record in official FDA databases Clinical performance, ungradable or failure rates, external and prospective validation, usability, subgroups, and workflow outcomes Device connectivity, worklist, PACS, EHR, reporting, identity, network, and result routing as applicable Device, software, cloud service, or combined workflow; confirm hardware, consumables, sites, users, and service model 2026-09-26

Caption Health

Developer of AI-guided ultrasound acquisition software, now part of GE HealthCare.

Vendor listings are informational and may include sponsored placements. All listings should be independently evaluated by qualified professionals before clinical adoption. Inclusion in this directory is not a clinical endorsement.