Archive

WatchMate Software — Anumana, Inc. (FDA K260300)

AI ECG analysis may flag cardiac risk earlier in routine radiology workflows, prompting timely cardiology referral.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 15 Jun

EchoNext — Pathwai, Inc. (FDA K260332)

AI-assisted echo analysis may speed up your workflow and flag subtle findings, but clinical validation is limited—use as an adjunct, not a replacement.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 8 Jun

ZEUS Platform (FG0501US) — iRhythm Technologies, Inc. (FDA K252859)

FDA-cleared AI platform for ECG analysis may streamline arrhythmia detection in your practice, potentially reducing manual review time.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 29 May

PCWP Analysis Software — Cardiosense, Inc. (FDA DEN250057)

This AI software estimates pulmonary capillary wedge pressure non-invasively, potentially reducing need for invasive catheterization in heart failure patients.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 22 May

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) — ABBOTT MEDICAL (FDA K253459)

For interventional cardiologists, this clearance expands AI-guided OCT imaging options, potentially improving stent placement accuracy and reducing procedural complications.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 24 Apr

Novasight Hybrid System — Conavi Medical, Inc. (FDA K252945)

Gives you a single catheter for combined IVUS and OCT, so you can size vessels and assess plaque without swapping devices during PCI.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 17 Apr

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) — Anumana, Inc. (FDA K253801)

This AI ECG algorithm flags cardiac amyloidosis earlier from a routine 12-lead, enabling timely diagnosis and treatment in a condition often missed.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 7 Apr

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) — Anumana, Inc. (FDA K252360)

This AI ECG algorithm may help screen for pulmonary hypertension from a routine 12-lead, enabling earlier referral and diagnosis in primary care.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 28 Mar

Automated Aortic Stenosis Software (AutoAS) — GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (FDA K254161)

AutoAS automates aortic stenosis grading on ultrasound, potentially reducing measurement variability and helping you triage valve disease faster in clinic.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 27 Mar

Tyto Stethoscope (G3) — Tyto Care , Ltd. (FDA K252089)

Lets you capture and share heart sounds remotely, supporting tele-consultations and follow-ups without an in-person visit.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 12 Mar