Autonomous Healthcare Receives FDA Authorization for Syncron-E Ventilator Analysis Software

Autonomous Healthcare has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its Syncron-E software, announced in a press release. The authorization establishes a new device classification for ventilator waveform analysis software, making Syncron-E the first product in this category.

Syncron-E assists respiratory therapists by analyzing recorded ventilator waveforms from adult patients on mechanical ventilation to detect evidence of ineffective efforts, the most common type of patient ventilator asynchrony. These asynchronies occur when a patient's breathing effort is not supported by the ventilator, a problem often missed during brief manual waveform checks.

The software provides an automated report summarizing waveform findings for clinical review, replacing the manual assessment process. With this authorization, Syncron-E is now classified as a Class II medical device and can be marketed in the United States. Autonomous Healthcare plans to introduce the tool into clinical practice and continue expanding its critical care technology platform.