FDA Authorizes New Software Category for Ventilator Waveform Analysis
Autonomous Healthcare has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its Syncron-E software, designed to detect patient-ventilator asynchrony. The authorization establishes a new FDA device classification.
SANTA CLARA, Calif., July 14, 2026 – Autonomous Healthcare announced today that the U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization for Syncron-E™, its software designed to assist respiratory therapists in assessing patient-ventilator asynchrony by detecting ineffective efforts. This authorization establishes an entirely new FDA device classification: ventilator waveform analysis software, with Syncron-E as the first-in-class device.
Patient-ventilator asynchrony, a mismatch between patient need and ventilator delivery, is a common and consequential problem in intensive care. Ineffective efforts, where a patient attempts to breathe but the ventilator does not adequately support the breath, are the most frequent type of asynchrony and can affect nearly half of mechanically ventilated patients. These episodes are often intermittent and subtle, making them difficult to detect during routine manual waveform checks.
Syncron-E addresses this challenge by analyzing previously recorded ventilator waveforms and summarizing findings for respiratory therapists. This automated approach aims to provide a structured method for detecting ineffective efforts, potentially improving patient outcomes by ensuring more timely recognition and management of this common issue.
"This FDA de novo grant is a milestone years in the making and a defining moment for Autonomous Healthcare," said Behnood Gholami, PhD, Co-Founder and Chief Executive Officer. "We took the harder path of creating a new device category because clinicians need tools that simply didn't exist before. Syncron-E is the first step in a much larger effort to introduce intelligent, increasingly autonomous technologies into the ICU and beyond."
The Syncron-E software is intended as an adjunctive aid for respiratory therapists to analyze recorded ventilator waveform data from adult patients receiving invasive mechanical ventilation. With this authorization, Syncron-E can now be marketed as a Class II medical device in the United States.