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Table 3 FDA cleared medical AI products

From: Application of machine learning in ophthalmic imaging modalities

AI products

Production companies

Applications

Kardia App

Kardia Band, Alive Cor, United States

Clinical grade wearable electrocardiogram in Apple Watch

The WAVE Clinical Platform

Excel Medical Electronics, United States

Patient surveillance and predictive algorithm platform

Embrace Watch

Embrace, United States

The smartwatch that uses sensors to measure stress and predict seizures

Viz LVO

Viz.AI, United States

Automatic detection of large vessel occlusion in suspected stroke patients

Cognoa App

Cognoa, United States

An app based on ML that can help clinicians diagnose autism rapidly

Guardian Connect

Medtronic, United States

The continuous glucose monitoring system for people on multiple daily insulin injections

IDx-DR

IDx, United States

To automatic diagnose DR before it causes blindness

OsteoDetect

Imagen Technologies, United States

A type of computer-aided detection and diagnosis software designed to detect wrist fractures in patients

DreaMed Advisor Pro

DreaMed Diabetes, Petah Tikvah, Israel

Automated insulin pump setting adjustments in patients with type 1 diabetes

Viz CTP

Viz.AI, United States

A software package to perform image processing and analysis of CT perfusion scans of the brain

  1. FDA = U.S. food and drug administration; DR = diabetic retinopathy; CT = computer tomographic; ML = machine learning