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FDA-listed AI/ML-enabled medical devices

Devices the FDA identifies as using artificial intelligence or machine learning, with the regulators each one is registered with.

1,330 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
BoneMRI v1.4

Mrlguidance B.V.

Registered with
  • US (FDA)
BoneMRI v1.6

MRIguidance B.V.

Registered with
  • US (FDA)
Bone VCAR (BVCAR)

Ge Medical Systems Scs

Registered with
  • US (FDA)
BoneView

Gleamer

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
BrainInsight

Hyperfine, Inc.

Registered with
  • US (FDA)
BrainInsight

Hyperfine Research, Inc.

Registered with
  • US (FDA)
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

Brainlab SE

Registered with
  • US (FDA)
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

Brainlab SE

Registered with
  • US (FDA)
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

Brainlab SE

Registered with
  • US (FDA)
Brainomix 360 e-ASPECTS

Brainomix Limited

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Brainomix 360 e-CTA

Brainomix Limited

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Brainomix 360 Hyperdensity

Brainomix Limited

Registered with
  • US (FDA)
Brainomix 360 Triage ICH

Brainomix Limited

Registered with
  • US (FDA)
Brainomix 360 Triage LVO

Brainomix Limited

Registered with
  • US (FDA)
Brainomix 360 Triage Stroke

Brainomix Limited

Registered with
  • US (FDA)
BrainScope Ahead 100

Brainscope Company, Inc.

Registered with
  • US (FDA)
Brainscope Ahead 200

Brainscope Company, Inc.

Registered with
  • US (FDA)
BrainScope TBI

Brainscope Company, Inc.

Registered with
  • US (FDA)
BrainSee

Darmiyan, Inc.

Registered with
  • US (FDA)
brAIn™ Shoulder Positioning

Avatar Medical

Registered with
  • US (FDA)
Brain WMH

Quantib B.V.

Registered with
  • US (FDA)
BraveCX

Bering Limited

Registered with
  • US (FDA)
  • UK (MHRA)
breastscape V1.0

Olea Medical

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
BriefCase

Aidoc Medical , Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
BriefCase-Quantification

Aidoc Medical , Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
BriefCase, RIB Fractures Triage (RibFx)

Aidoc Medical , Ltd.

Registered with
  • US (FDA)
Briefcase-Triage

Aidoc Medical , Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
BriefCase-Triage: CARE Multi-triage CT Body

Aidoc Medical , Ltd.

Registered with
  • US (FDA)
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Aidoc Medical , Ltd.

Registered with
  • US (FDA)
BrightHeart View Classifier

Brightheart

Registered with
  • US (FDA)
Broncholab

FLUIDDA NV

Registered with
  • US (FDA)
  • EU (EUDAMED)
BU-CAD

Taihao Medical, Inc.

Registered with
  • US (FDA)
Bunkerhill Abdominal Aortic Quantification (AAQ)

Bunkerhill Health

Registered with
  • US (FDA)
Bunkerhill AVC

Bunkerhill Health

Registered with
  • US (FDA)
BunkerHill BMD

Bunkerhill Health

Registered with
  • US (FDA)
Bunkerhill Contrast AVC

Bunkerhill Health

Registered with
  • US (FDA)
Bunkerhill Contrast CAC

Bunkerhill Health

Registered with
  • US (FDA)
Bunkerhill ECG-EF

Bunkerhill Health

Registered with
  • US (FDA)
Bunkerhill MAC

Bunkerhill Health

Registered with
  • US (FDA)
Butterfly Gestational Age Tool

Butterfly Network, Inc.

Registered with
  • US (FDA)
Butterfly iQ3 Ultrasound System

Butterfly Network, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Butterfly iQ/iQ+ Ultrasound System

Butterfly Network, Inc.

Registered with
  • US (FDA)
CAC (gated) Algorithm

Bunkerhill Health

Registered with
  • US (FDA)
CAC Software

Imbio, LLC

Registered with
  • US (FDA)
  • Canada (Health Canada)
CADDIE

Odin Medical Limited

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Canvas Dx

Cognoa, Inc.

Registered with
  • US (FDA)
Capnostream™35 Portable Respiratory Monitor (PM35MN)

Covidien

Registered with
  • US (FDA)
Caption Guidance

Bay Labs, Inc.

Registered with
  • US (FDA)
Caption Guidance

Caption Health

Registered with
  • US (FDA)
  • EU (EUDAMED)
Caption Interpretation Automated Ejection Fraction Software

Caption Health

Registered with
  • US (FDA)