New FDA AI clearances
2026 decisions on the FDA AI-enabled device list from vendors we rank, newest first. Each links to the FDA record and the product site. The FDA list was last updated before 2026-10-14; it currently runs through June 2026 decisions.
06/26/2026 · Radiology
MammoScreen® (5)
Therapixel
Vendor’s ranked product: MammoScreen · Vendor site ↗
06/25/2026 · Radiology
syngo.CT Coronary Cockpit
Siemens Medical Solutions USA, Inc.
Vendor’s ranked product: Siemens Healthineers Deep Resolve · Vendor site ↗
06/24/2026 · Radiology
Enhanced Boundary for PCCT
Ge Medical Systems, LLC
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗
06/16/2026 · Radiology
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Vendor’s ranked product: Siemens Healthineers Deep Resolve · Vendor site ↗
06/15/2026 · Radiology
LungMaps
Siemens Healthineers AG
Vendor’s ranked product: Siemens syngo.CT Lung CAD · Vendor site ↗
06/15/2026 · Radiology
Saige-Dx
DeepHealth, Inc.
Vendor’s ranked product: DeepHealth Saige-Dx · Vendor site ↗
06/15/2026 · Radiology
WatchMate Software
Anumana, Inc.
Vendor’s ranked product: Anumana ECG-AI · Vendor site ↗
06/12/2026 · Radiology
Brainomix 360 Hyperdensity
Brainomix Limited
Vendor’s ranked product: Brainomix 360 · Vendor site ↗
05/22/2026 · Radiology
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
Canon Medical Informatics, Inc.
Vendor’s ranked product: Canon AiCE for MR · Vendor site ↗
05/21/2026 · Radiology
BAC
DeepHealth, Inc.
Vendor’s ranked product: DeepHealth Saige-Dx · Vendor site ↗
05/20/2026 · Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
Canon Medical Systems Corporation
Vendor’s ranked product: Canon AiCE for MR · Vendor site ↗
05/15/2026 · Radiology
SubtleHD-CT (1.x)
Subtle Medical, Inc.
Vendor’s ranked product: SubtleMR · Vendor site ↗
05/14/2026 · Radiology
SubtleHD-PET (1.x)
Subtle Medical, Inc.
Vendor’s ranked product: SubtleMR · Vendor site ↗
05/04/2026 · Pathology
ArteraAI Breast
Artera, Inc.
Vendor’s ranked product: ArteraAI Prostate · Vendor site ↗
04/30/2026 · General Hospital
Bayesian Health Sepsis Flagging Device
Bayesian Health, Inc.
Vendor’s ranked product: Bayesian Health TREWS · Vendor site ↗
04/29/2026 · Radiology
syngo Application Software
Siemens Medical Solutions USA, Inc.
Vendor’s ranked product: Siemens Healthineers Deep Resolve · Vendor site ↗
04/23/2026 · Radiology
Lunit INSIGHT MMG (v1.1.10)
Lunit, Inc.
Vendor’s ranked product: Lunit INSIGHT MMG / DBT · Vendor site ↗
04/14/2026 · Radiology
Critical Care Suite with Enteric Tube Positioning AI Algorithm
Ge Medical Systems, LLC
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗
04/10/2026 · Radiology
AI-Rad Companion Organs RT
Siemens Healthcare GmbH
Vendor’s ranked product: Siemens syngo.CT Lung CAD · Vendor site ↗
04/10/2026 · Radiology
syngo Dynamics (VA41F)
Siemens Healthcare GmbH
Vendor’s ranked product: Siemens syngo.CT Lung CAD · Vendor site ↗
04/10/2026 · Radiology
Overjet Iris Intelligent Imaging System
Overjet, Inc.
Vendor’s ranked product: Overjet · Vendor site ↗
04/07/2026 · Cardiovascular
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
Anumana, Inc.
Vendor’s ranked product: Anumana ECG-AI · Vendor site ↗
03/28/2026 · Cardiovascular
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
Vendor’s ranked product: Anumana ECG-AI · Vendor site ↗
03/27/2026 · Radiology
Butterfly Gestational Age Tool
Butterfly Network, Inc.
Vendor’s ranked product: Butterfly iQ · Vendor site ↗
03/27/2026 · Radiology
Automated Aortic Stenosis Software (AutoAS)
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗
03/27/2026 · Radiology
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Vendor’s ranked product: Canon AiCE for MR · Vendor site ↗
03/27/2026 · Radiology
Contour ProtégéAI+
Mim Software, Inc.
Vendor’s ranked product: MIM Contour ProtégéAI · Vendor site ↗
03/26/2026 · Radiology
Lunit INSIGHT DBT (V1.2)
Lunit, Inc.
Vendor’s ranked product: Lunit INSIGHT MMG / DBT · Vendor site ↗
03/24/2026 · Radiology
LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗
03/20/2026 · Radiology
Photonova Spectra, Photonova Spectra Select
Ge Medical Systems, LLC
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗
03/20/2026 · Radiology
SOMATOM X.cite; SOMATOM X.ceed
Siemens Medical Solutions USA, Inc.
Vendor’s ranked product: Siemens Healthineers Deep Resolve · Vendor site ↗
03/19/2026 · Radiology
AutoContour (RADAC V5)
Radformation, Inc.
Vendor’s ranked product: Radformation AutoContour · Vendor site ↗
03/13/2026 · Radiology
Aquilion ServeSP (TSX-307B) V2.0
Canon Medical Systems Corporation
Vendor’s ranked product: Canon AiCE for MR · Vendor site ↗
03/10/2026 · Radiology
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
Canon Medical Systems Corporation
Vendor’s ranked product: Canon AiCE for MR · Vendor site ↗
03/06/2026 · Radiology
Bunkerhill Contrast CAC
BunkerHill Health
Vendor’s ranked product: Bunkerhill ECG-EF · Vendor site ↗
03/06/2026 · Radiology
Bunkerhill Contrast AVC
BunkerHill Health
Vendor’s ranked product: Bunkerhill ECG-EF · Vendor site ↗
02/24/2026 · Radiology
AI Platform 2.2 (AIP002)
Exo Imaging
Vendor’s ranked product: Exo AI Platform · Vendor site ↗
02/10/2026 · Radiology
MI View&GO
Siemens Medical Solutions USA, Inc.
Vendor’s ranked product: Siemens Healthineers Deep Resolve · Vendor site ↗
02/06/2026 · Radiology
SIGNA™ Bolt
Ge Medical Systems, LLC
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗
02/05/2026 · Radiology
SIGNA™ Sprint Select
Ge Medical Systems, LLC
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗
01/22/2026 · Radiology
AI-Rad Companion Brain MR
Siemens Healthcare GmbH
Vendor’s ranked product: Siemens syngo.CT Lung CAD · Vendor site ↗
01/16/2026 · Radiology
qXR-Detect
Qure.Ai Technologies
Vendor’s ranked product: Qure.ai qXR · Vendor site ↗
01/15/2026 · Radiology
BIOGRAPH One
Siemens Healthineers AG
Vendor’s ranked product: Siemens syngo.CT Lung CAD · Vendor site ↗
01/09/2026 · Cardiovascular
Corvair Monza
AliveCor, Inc.
Vendor’s ranked product: AliveCor KardiaAI · Vendor site ↗
01/08/2026 · Radiology
LOGIQ Totus
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗
01/07/2026 · Radiology
LOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vendor’s ranked product: GE HealthCare AIR Recon DL · Vendor site ↗