AiTia SIRIES
This is a software diagnostic aid that analyzes
ECGs and assesses AI disease risk scores.
  • ECG data
  • AiTiA Series algorithm
  • Send / Share analysis results
Series 1

MFDS(Korea FDA) Innovative Medical device Designation No.29

February 16, 2023

Minister of Health and Welfare announcement (No. 2023-78) Selection of Innovative medical technologies

April 27, 2023

Public Procurement Service Innovative device Designation No.2023-089

July 31, 2023

IR52 Jang Young-shil Award

April 16, 2024

Series 2

MFDS(Korea FDA) Innovative Medical device Designation No.45

September 25, 2023

New Excellent Technology Certification No.210

December 07, 2023

Minister of Health and Welfare announcement (No. 2024-68) Selection of Innovative medical technologies

January 27, 2023

The AiTiA Series will expand to include various disease prediction capacities through continuing R&D and licensing procedures.
The above content is unrelated to the  medical device advertising review

Class II ECG analysis software license no.23-499 (March 29, 2023)

AiTiA
Left Ventricular Systolic Dysfunction
The software as a medical device analyzes 12-lead ECG data using artificial intelligence to indicate the likelihood of left ventricular systolic dysfunction with scores and risk assessment.
* This product is a medical device. Please carefully read and understand the instructions for use and precautions before using.

Single-Center pivotal clinical study (688 participants, 15% prevalence) [1]

Primary outcome :  AUROC 0.919

Secondary outcome :  Minimized false positives to reduce clinical burden (PPV 0.715)
Excellent negative predictive value to minimize missing cases (NPV 0.982)

* AiTiALVSD pivotal clinical study report

Score and risk level display [2]

Class II ECG analysis software license no.23-1044 (November 08, 2023)

AiTiA
Myocardial Infarction
The software as a medical device analyzes 12-lead ECG data using artificial intelligence to indicate the likelihood of acute myocardial infarction with scores and risk assessment.
* This product is a medical device. Please carefully read and understand the instructions for use and precautions before using.

Pivotal clinical study involving 1,667 adults with suspected acute myocardial infarction (prevalence 15%) [3]

Primary outcome :  AUROC 0.917 (95% confidence interval 0.897-0.936)

Secondary outcome :  Negative predictive value of 100% for the low-risk group (cutoff: less than 3.0)
Positive predictive value of 56.4% for the high-risk group (cutoff: 48.5 or higher)

* Performance comparison of subgroups with acute myocardial infarction, AiTiAMI pivotal clinical study result report
[Confusion matrix based on low-risk group]
Reference Standard
Case Control Total
AiTiAMI
Result		 Case 245 1,239 1,484
Control 0 150 150
Total 245 1,389 1,634
[Confusion matrix based on High-risk group]
Reference Standard
Case Control Total
AiTiAMI
Result		 Case 245 1,239 1,484
Control 0 150 150
Total 245 1,389 1,634

Score and risk level display [4]

AiTiALVSD

AiTiAMI