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	Manufacturer	US	UK	CA	AU	EU
FFRangio System Cathworks, Ltd. Registered with US (FDA) EU (EUDAMED)	Cathworks, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
FFRct Heartflow Registered with US (FDA) Canada (Health Canada)	Heartflow	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Fibresolve Imvaria, Inc. Registered with US (FDA)	Imvaria, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Fibresolve (with PCCP) Imvaria, Inc. Registered with US (FDA)	Imvaria, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
FibriCheck Qompium NV Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Qompium NV	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
FLASH EVD System (10-0002) 7D Surgical Ulc Registered with US (FDA)	7D Surgical Ulc	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
FlightPlan for Embolization Ge Medical Systems Scs Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Ge Medical Systems Scs	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
FlightPlan for Liver Ge Medical Systems Scs Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Ge Medical Systems Scs	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
FluChip-8G Influenza A+B Assay Indevr, Inc. Registered with US (FDA)	Indevr, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
FOCALPOINT SYSTEMCREENING SYSTEM Bd Diagnostics Registered with US (FDA)	Bd Diagnostics	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Follicle Clarity Cycle Clarity Registered with US (FDA)	Cycle Clarity	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
FOLLISCAN MIM Fertility Sp. z o.o. Registered with US (FDA) EU (EUDAMED)	MIM Fertility Sp. z o.o.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Formus Hip Formus Labs, Ltd. Registered with US (FDA) AU (TGA)	Formus Labs, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
FractureDetect (FX) Imagen Technologies, Inc. Registered with US (FDA)	Imagen Technologies, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Galen™ Second Read™ Ibex Medical Analytics Ltd Registered with US (FDA)	Ibex Medical Analytics Ltd	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Gastric Alimetry Alimetry , Ltd. Registered with US (FDA)	Alimetry , Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GBrain MRI Galileo Cds, Inc. Registered with US (FDA)	Galileo Cds, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) Geneseeq Technology, Inc. Registered with US (FDA)	Geneseeq Technology, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Genius AI Detection Hologic Inc Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Hologic Inc	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Genius AI Detection 2.0 Hologic Inc Registered with US (FDA)	Hologic Inc	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Genius AI Detection 2.0 with CC-MLO Correlation Hologic Inc Registered with US (FDA)	Hologic Inc	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
"Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm" Hologic Inc Registered with US (FDA)	Hologic Inc	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GI Genius Cosmo Artificial Intelligence - Ai, Ltd. Registered with US (FDA)	Cosmo Artificial Intelligence - Ai, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) Cosmo Artificial Intelligence - Ai, Ltd. Registered with US (FDA)	Cosmo Artificial Intelligence - Ai, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) Cosmo Artificial Intelligence - Ai, Ltd. Registered with US (FDA)	Cosmo Artificial Intelligence - Ai, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) Cosmo Artificial Intelligence - Ai, Ltd. Registered with US (FDA)	Cosmo Artificial Intelligence - Ai, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GI Genius System 100 and GI Genius System 200 Cosmo Artificial Intelligence - Ai, Ltd. Registered with US (FDA)	Cosmo Artificial Intelligence - Ai, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Gili Pro BioSensor (also known as "Gili BioSensor System") Continuse Biometrics , Ltd. Registered with US (FDA)	Continuse Biometrics , Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Global Hypoperfusion Index (GHI) Algorithm Edwards Lifesciences, LLC Registered with US (FDA)	Edwards Lifesciences, LLC	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GoLIF! Lumbar Interbody Fusion System Getset Surgical, SA Registered with US (FDA)	Getset Surgical, SA	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GyriCalc (Version 1.0.0) Neurospectrum Insights Corp. Registered with US (FDA)	Neurospectrum Insights Corp.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HALO Nico-Lab B.V. Registered with US (FDA)	Nico-Lab B.V.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HALO Nicolab B.V. Registered with US (FDA)	Nicolab B.V.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthCCS Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthCCSng Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthCCSng Nano-X AI Ltd Registered with US (FDA) EU (EUDAMED)	Nano-X AI Ltd	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
HealthCXR Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthFLD Nano-X AI Ltd Registered with US (FDA)	Nano-X AI Ltd	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthICH Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthJOINT Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthMammo Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthOST Nanoxai , Ltd. Registered with US (FDA)	Nanoxai , Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthPNX Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthPPT Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HealthVCF Zebra Medical Vision, Ltd. Registered with US (FDA)	Zebra Medical Vision, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Heartflow Analysis Heartflow Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Heartflow	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
HeartFlow FFRct Analysis Heartflow Registered with US (FDA)	Heartflow	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HeartFocus Deski Registered with US (FDA)	Deski	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HeartFocus (V.1.1.1) Deski Registered with US (FDA)	Deski	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HeartKey® Rhythm B-Secur , Ltd. Registered with US (FDA)	B-Secur , Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)