Medtronic nets heartening FDA nod for AI algorithms to detect afib, arrhythmia

Medtronic nets heartening FDA nod for AI algorithms to detect afib, arrhythmia

Medtronic has its heart set on ensuring that its insertable cardiac monitors are as accurate as possible, and a new pair of artificial intelligence algorithms might be just the ticket.

The AccuRhythm algorithms read cardiac data collected by Medtronic’s implantable monitors to identify abnormalities in a patient’s heartbeat, then automatically alert the patient’s cardiologist and care team to speed up treatment of the irregular rhythm.

The AI was trained on a database of more than 1 million electrocardiogram readings. With that extensive training, the algorithms aim to send out only the most accurate alerts to instances of atrial fibrillation or asystole, a common cause of cardiac arrest in which an extended pause occurs between heartbeats.

Both cloud-based algorithms are newly cleared by the FDA, allowing them to be deployed for use in reading the heart rhythm data collected by Medtronic’s Linq II insertable cardiac monitor, which the company claims is already the most accurate monitor available.

The AccuRhythm AI will be accessible through Medtronic’s CareLink Network digital platform for patient management later this year.

Alongside the FDA OKs, Medtronic also offered a preview of the results of a study validating the AccuRhythm software’s afib- and asystole-detecting abilities. The full results are slated to be presented at the Heart Rhythm Society’s annual meeting later this week.

According to Medtronic’s data, the algorithm designed to identify instances of an accelerated or otherwise irregular heartbeat correctly identified more than 99% of afib instances, while also reducing false alarms by about 74%.

The asystole-specific “Pause” algorithm, meanwhile, almost completely eliminated false alarms, cutting them down by more than 97%. At the same time, it was able to identify 100% of all true asystole occurrences.

“Applying AccuRhythm AI to LINQ II data is a significant ICM innovation, enabling us to reduce clinical inefficiencies resulting from false alerts and help physicians better identify and focus on the actionable data they need to treat their patients,” said Rob Kowal, M.D., Ph.D., chief medical officer of Medtronic’s cardiovascular diagnostics and services business.

The upgrade comes almost exactly one year after Medtronic was given the regulatory go-ahead to begin rolling out the Linq II device in both the U.S. and Europe, for patients who must be continuously monitored for symptoms like dizziness and chest pain due to abnormal heart rhythm.

Since its debut, Linq II has been touted as a longer-lasting and significantly more accurate alternative to other insertable cardiac monitors. It can be implanted for up to four and a half years and—even before the introduction of the new AI algorithms—registered the lowest rate of false afib alerts of all similar devices.

Linq II also boasts a tiny footprint, measuring in at about one-third the size of a AAA battery. Plus, it can be remotely adjusted and monitored through Medtronic’s smartphone app or in-home communication device, a feature that was especially important as the monitor was launched amid the throes of the COVID-19 pandemic.

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