Autonomous Healthcare Gains Novel FDA Category for Ventilator Waveform Analysis

Autonomous Healthcare has received De Novo marketing authorisation from the US Food and Drug Administration for Syncron-E, software designed to help respiratory therapists identify evidence of ineffective breathing efforts in mechanically ventilated adults.

The authorisation establishes a new FDA device classification for ventilator waveform analysis software, with Syncron-E becoming the first device in the category. 

The new classification also provides a regulatory pathway for future technologies designed to analyse ventilator waveform data.

Patient-ventilator asynchrony occurs when a patient's breathing effort does not match the support delivered by a ventilator. Ineffective efforts are a common form of this problem and can be difficult to identify because they may occur intermittently during mechanical ventilation.

Syncron-E analyses previously recorded ventilator waveforms and presents the findings to respiratory therapists for review. 

The software is intended to provide a structured method for identifying evidence of ineffective efforts, supporting clinical assessment rather than replacing professional judgement.

The device is intended for use with waveform data from patients aged 22 years and older who are receiving invasive mechanical ventilation.

 Its development has been supported by performance data collected across multiple clinical sites.

Following the De Novo authorisation, Syncron-E can be marketed in the US as a Class II medical device. Autonomous Healthcare plans to introduce the software into clinical practice while continuing development of technologies for critical care.