Radiology gets 68 new FDA-cleared algorithms
The U.S. Food and Drug Administration (FDA) updated its list of cleared artificial intelligence (AI) algorithms, and radiology still maintains its vast lead over the rest of medicine.
The agency's June 16 update showed 68 new radiology algorithms were cleared just in the first three months of 2026. There are now a total of 1,524 FDA-cleared AI algorithms as of March 30, 2026, and 1,163 of them are for radiology, which now accounts for 76.31% of all FDA-cleared AI. The actual total for medical imaging AI listed under other specialties like orthopedics, cardiology and neurology brings the total closer to 80%.
The FDA has seen an increasing number of AI approvals for the past several years, now clearing about 30 a month. In 2024, the FDA was clearing an average of 21 per month
AI is now a major topic of discussion at nearly all medical conferences, but this has been the case at radiology meetings for the past decade. With the sheer number of clinical medical imaging algorithms now available, the Radiology Society of North America (RSNA) annual meeting has by default become the largest conference in the world for FDA-cleared AI. A quarter of its massive expo floor is dedicated to AI vendors, and at least another 60% of the show floor vendors offer AI of some sort baked into their software or hardware.
The most recent list of AI radiology AI FDA-cleared products includes both novel technologies and updates to existing systems:
• AiORTA - Plan v2.0, ViTAA Medical Solutions,
• Spectral CT Verida Family, Philips Healthcare
• Butterfly Gestational Age Tool, Butterfly Network Inc.
• Automated Aortic Stenosis Software (AutoAS), GE Medical Systems Ultrasound
• Epiq Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System, Philips Ultrasound
• Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRI, Canon Medical Systems
• S-scan Open (100001800), Esaote
• Contour ProtégéAI+, Mim Software
• Lunit Insight DBT (V1.2), Lunit Inc.
• wiftMR, Airs Medical Inc.
• Trinias, Shimadzu
• JLK-NCCT, JLK, Inc.
• Logiq series update, GE Medical Systems Ultrasound
• CT Rembra RT; CT Areta RT; CT Rembra, Philips Healthcare
• True Definition DL, GE Healthcare
• Photonova Spectra, Photonova Spectra Select, GE Medical Systems
• Somatom X.cite; SOMATOM X.ceed, Siemens
• AutoContour (RADAC V5), Radformation, Inc.
• syngo.via RT Image Suite VC10, Varian Medical Systems, Inc.
• EchoNavigator R5.0 Philips Medical Systems Nederland B.V.
• Data Analysis Facilitation Suite (DAFS), Voronoi Health Analytics
• Sonio Detect (v3), Sonio
• InferCare RECIST, Beijing Infervision Healthcare Medical Technology
• Aquilion ServeSP (TSX-307B) V2.0, Canon Medical Systems
• Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension), Canon Medical Systems
• LiverMultiScan (v6.0), Perspectum Ltd.
• Bunkerhill Contrast CAC, BunkerHill Health
• Bunkerhill Contrast AVC, BunkerHill Health
• VELYS Hip Navigation, Depuy Ireland UC
• EarliPoint Assessment, Earlitec Diagnostics
• CEPHX3D, Orca Dental AI , Ltd.
• AV Cardiac CT, Philips Medical Systems
• Magnifico Open (100009900), Esaote
• QT Scanner 2000 Model A, QT Imaging
• Annalise Enterprise, Harrison-AI Medical
• Clarius Ejection Fraction AI, Clarius Mobile Health
• Ligence Heart, Ligence Uab
• BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device, Aidoc Medical
• AI Platform 2.2 (AIP002), Exo Imaging
• Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades, Philips
• CARA System, Cara Medical
• Monaco RTP System (6.3), Elekta Solutions
• MI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES), Shanghai United Imaging
• Delivery Date AI, Ultrasound AI
• AI4CMR v2.0, Ai4medimaging Medical Solutions
• MI View&GO, Siemens
• Median LCS/eyonis LCS, Median Technologies
• Signa Bolt, GE Medical Systems
• Signa Sprint Select, GE Medical Systems
• RevealAI-Lung, Precision Medical Ventures
• Surgical Reality Viewer, Medicalvr
• Neurophet AQUA AD Plus, Neurophet
• Seg Pro V3 (RT-300), Ever Fortune.Ai
• BriefCase-Triage, Aidoc Medical
• AccuContour 4.0, Manteia Technologies
• AV Vascular, Philips
• AI-Rad Companion Brain MR, Siemens
• uCT 780 with uWS-CT-Dual Energy Analysis, Shanghai United Imaging
• qXR-Detect, Qure.Ai
• Imagine Enterprise Suite, Softlink International
• Diagnocat, DGNCT
• Biograph One, Siemens
• MLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) Elekta Solutions
• Verizon CT 300, 316/364, and 400 series Digital SPECT/CT Systems, Spectrum Dynamics
• Logiq Totus, GE Medical Systems Ultrasound
• DS Core Detect, Dentsply Sirona
• Magnetom Flow.Ace; Magnetom Flow.Plus, Siemens
• BriefCase-Triage: CARE Multi-triage CT Body, Aidoc Medical
• Logiq Fortis, GE Medical Systems Ultrasound
• HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System, Samsung Medison
The breakdown by speciality of all 1,524 FDA-cleared AI algorithms as of March 30, 2026 (list released by FDA on June 16, 2026):
• Radiology 1,163
• Cardiology 146 (or 225 including cardiovascular-specific AI listed under radiology)
• Neurology 69
• Anesthesiology 26
• Gastroenterology and urology 24
• Hematology 20
• Ophthalmic 10
• Clinical chemistry 9
• Pathology 9
• General and plastic surgery 8
• Microbiology 7
• Orthopedic 7
• Dental 5
• Clinical Toxicology 5
• General Hospital 5
• OB/GYN 4
• Ear, nose and throat 1
• Physical Medicine 1
• Immunology 1
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]