Cardiology still one of the top specialties for FDA-cleared AI algorithms
Another 22 new artificial intelligence (AI) algorithms have been cleared for the field of cardiology by the U.S. Food and Drug Administration (FDA), raising the total number for the specialty to 225. This includes 146 algorithms listed specifically under cardiology and 69 others for cardiovascular imaging.
Cardiology remains No. 2 in FDA-cleared AI models, trailing only radiology. In total, the agency has now cleared a total of 1,524 since its first approval in 1995. This is all according to an updated list the FDA released on June 16.
These cardiovascular AI models are used for a wide variety of purposes. This includes the detection of various cardiovascular findings in medical images; improving angiography image quality and guidance in the cath lab; EP ablation procedural guidance; automated image assessment and quantification for things such as echocardiography exams and much more.
The list of new cardiovascular AI algorithms includes new algorithms/devices as well as updates to existing systems:
• ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020), Anumana
• Tyto Stethoscope (G3), Tyto Care
• Carto, Biosense Webster
• PreemptiveAI Clinical SDK, Measure Labs (Preemptiveai Inc.)
• SafeBeat Rx App, SafeBeat Rx Inc.
• Vital Signs, Oxehealth Limited
• BodyGuardian Remote Monitoring System (BGRMS v3.0), Boston Scientific Cardiac Diagnostic Technologies, Inc.
• Perin Health System (PHD80060-2), Perin Health Devices LLC
• Corvair Monza, AliveCor Inc.
• Veriton CT 300 and 400 series digital SPECT/CT systems, Spectrum Dynamics Medical
• AV Vascular, Philips Medical Systems Nederland B.V.
• AV Cardiac CT, Philips Medical Systems Nederland B.V.
• BriefCase-Triage: CARE Multi-Triage CT for Pericardial effusion and Large aortic aneurysm, Aidoc Medical
• Ligence Heart, Ligence Uab
• Clarius Ejection Fraction AI, Clarius Mobile Health Corp.
• Bunkerhill Contrast CAC, BunkerHill Health
• Bunkerhill Contrast AVC, BunkerHill Health
• Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension), Canon Medical Systems
• EchoNavigator R5.0, Philips Medical Systems Nederland B.V.
• Trinias, Shimadzu Corporation
• Automated Aortic Stenosis Software (AutoAS), GE Medical Systems Ultrasound & Primary Care Diagnostics
• AiORTA - Plan v2.0, ViTAA Medical Solutions Inc.
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]