OMB Individually Reported

LINQ II Insertable Cardiac Monitor

Low riskExact public inventory row

Description

The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient.

Detailed example

The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings.

AI / analytics pattern

Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relationships.

Automation level / stage

c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

Expected benefit

Improve detection and recording of arrythmias.

Controls / human review

ATO: Not reported; PIA: Not published