Health · Healthcare & Policy · 2 hrs ago
No adverse-event reports for South Korea’s AI medical devices in three years
South Korea’s AI medical devices help health workers read scans and support disease diagnoses.
Their approvals, certifications and registrations rose from 62 in 2023 to 157 last year, reaching 382 in total by the end of this year’s first quarter.
Yet no adverse events involving AI or digital medical devices were reported from 2023 through June this year.
Other new medical technologies, including in vitro diagnostic devices, had 27 reports over the same period.
The figures do not show whether no problems occurred or whether problems were missed by the reporting system.
Software errors or missed findings could delay diagnoses and affect patient safety.
A lawmaker has called for clearer reporting rules and checks on whether hospitals and companies are reporting incidents; no further action is specified.
South Korea recorded no adverse-event reports involving AI and digital medical devices from 2023 through June 2026.
During the same period, approvals, certifications and notifications for AI-based software medical devices rose from 62 in 2023 to 157 in 2025.
The total reached 382 from 2023 through the first quarter of 2026.
A lawmaker said the lack of reports could signal that the system for detecting software errors is not working.
The report said algorithm errors or missed readings could delay diagnosis and affect patient safety.
- Who
- South Korea’s AI and digital medical devices, and lawmaker Heo Jong-sik, who raised concerns about reporting.
- What
- No adverse-event reports were recorded for the devices, despite a rise in approvals, certifications and notifications.
- When
- From 2023 through June 2026.
- Where
- South Korea.
- Why
- Not stated. Heo said the absence of reports could indicate a problem with the reporting system.
This story does not have two clearly opposing sides.
Even though reporting is legally required, the fact that there has not been a single report for AI medical devices in more than three years may be a signal that the reporting system for detecting software errors is not working.
The criteria should be revised so that risks specific to software can be reported as adverse events, and checks should be made to see whether medical institutions and companies are actually reporting them.
South Korea recorded 62 approvals, certifications and notifications for AI-based software medical devices.
The number of approvals, certifications and notifications rose to 108.
The number rose to 157.
A further 55 approvals, certifications and notifications brought the total since 2023 to 382.
No adverse-event reports involving AI and digital medical devices were recorded for the period beginning in 2023.
- Adverse-event reports
- 0 from 2023 through June 2026
- AI software device approvals, certifications and notifications
- 62 in 2023
- AI software device approvals, certifications and notifications
- 108 in 2024
- AI software device approvals, certifications and notifications
- 157 in 2025
- Cumulative approvals, certifications and notifications
- 382 through the first quarter of 2026
- All new-technology medical devices
- 27 adverse-event reports during the same period
Sources
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