Autonomous Healthcare has received U.S. FDA De Novo marketing authorization for Syncron-E, a software device designed to support respiratory therapists in assessing patient-ventilator asynchrony.

The authorization establishes a new FDA device classification for ventilator waveform analysis software, with Syncron-E as the first device in the category. The software may now be marketed as a Class II medical device in the United States.

Patient-ventilator asynchrony is a common challenge in intensive care. When a patient’s breathing effort is not well matched with the ventilator, it can affect comfort, ventilation quality and clinical management. However, asynchrony can be intermittent and difficult to detect manually, especially when respiratory therapists are managing multiple patients.

Syncron-E is designed to analyse previously recorded ventilator waveform data from adult patients aged 22 years and older receiving invasive mechanical ventilation. It detects evidence of ineffective effort, the most frequent type of patient-ventilator asynchrony, and summarises findings for respiratory therapists to review.

The product replaces a manual and time-consuming task with a more structured software-assisted workflow. This could support respiratory therapists by highlighting potential issues that may otherwise be missed during routine care.

The development is important because critical care environments are under pressure from staffing constraints, high patient acuity and complex monitoring demands. Software tools that automate waveform review may help clinicians focus attention where intervention may be needed.

Syncron-E is supported by multi-site performance data, according to the company. Autonomous Healthcare said the system is part of its broader goal of introducing intelligent and increasingly autonomous technologies into intensive care and other clinical settings.