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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.

1,255 devices · when each source was last refreshed

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

Device
AutoDensity

Eos Imaging

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Auto Lung Nodule Detection

Samsung Electronics Co., Ltd.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Automated Aortic Stenosis Software (AutoAS)

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Automatic Anatomy Recognition (AAR)

Quantitative Radiology Solutions, LLC

Registered with
  • US (FDA)
Automatic Registration

Brainlab SE

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Autoplaque

Cedars-Sinai Medical Center: Aim

Registered with
  • US (FDA)
Auto Positioning

Ge Hangwei Medical Systems Co., Ltd.

Registered with
  • US (FDA)
autoSCORE

Holberg Eeg AS

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
autoSCORE (V 2.0.0)

Holberg Eeg AS

Registered with
  • US (FDA)
Auto Segmentation

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
  • EU (EUDAMED)
AVA (Augmented Vascular Analysis)

See-Mode Technologies Pte, Ltd.

Registered with
  • US (FDA)
AV Cardiac CT

Philips Medical Systems Nederland BV

Registered with
  • US (FDA)
Avenda Health AI Prostate Cancer Planning Software

Avenda Health, Inc.

Registered with
  • US (FDA)
AVIEW

Coreline Soft Co.,Ltd

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
AVIEW CAC

Coreline Soft Co.,Ltd

Registered with
  • US (FDA)
A View LCS

Coreline Soft Co.,Ltd

Registered with
  • US (FDA)
AVIEW LCS

Coreline Soft Co.,Ltd

Registered with
  • US (FDA)
AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd

Registered with
  • US (FDA)
AVIEW RT ACS

Coreline Soft Co.,Ltd

Registered with
  • US (FDA)
Avive Automated External Defibrillator (AED) System

Avive Solutions, Inc.

Registered with
  • US (FDA)
AV Vascular

Philips Medical Systems Nederland BV

Registered with
  • US (FDA)
Axial3D Insight

Axial Medical Printing Limited

Registered with
  • US (FDA)
BD FocalPoint GS Imaging System

Bd Diagnostics

Registered with
  • US (FDA)
Belun Sleep System BLS-100

Belun Technology Company Limited

Registered with
  • US (FDA)
Better Diagnostics Caries Assist (BDCA) Version 1.0

Better Diagnostics AI Corp

Registered with
  • US (FDA)
Biograph Horizon

Siemens Medical Solution

Registered with
  • US (FDA)
BIOGRAPH One

Siemens Healthineers

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Biograph Vision, Biograph mCT Family of PET/CTs

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
Biograph Vision.X and Biograph Vision.X Edge

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
Biograph VK10

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

Bio-Rad Laboratories, Inc.

Registered with
  • US (FDA)
BioticsAI

Bioticsai, Inc.

Registered with
  • US (FDA)
BioTraceIO Vision (V1.7)

Techsomed Medical Technologies , Ltd.

Registered with
  • US (FDA)
Biovitals Analytics Engine

Biofourmis Singapore Pte., Ltd.

Registered with
  • US (FDA)
Bladder AI (AIBV01)

EXO S.A.

Registered with
  • US (FDA)
BladderScan Prime PLUS System

Verathon Incorporated

Registered with
  • US (FDA)
BlineSlide

Deep Breathe, Inc.

Registered with
  • US (FDA)
BodyGuardian Remote Monitoring System

Preventice Technologies, Inc.

Registered with
  • US (FDA)
BodyGuardian Remote Monitoring System (BGRMS v3.0)

BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.

Registered with
  • US (FDA)
Bonelogic

Disior, Ltd.

Registered with
  • US (FDA)
BoneMetrics (US)

Gleamer

Registered with
  • US (FDA)
BoneMRI

MRIguidance B.V.

Registered with
  • US (FDA)
  • EU (EUDAMED)
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)