SANTA CLARA, Calif., July 14, 2026 /PRNewswire/ — Autonomous Healthcare today announced that the U.S. Food and Drug Administration (FDA) has granted the De Novo marketing authorization for Syncron-E™, its software that supports respiratory therapists’ assessment of patient-ventilator asynchrony by detecting evidence of ineffective efforts. The De Novo grant establishes an entirely new FDA device classification, ventilator waveform analysis software, with Syncron-E as its first-in-class device. Syncron-E sets the regulatory pathway that future ventilator waveform analysis software will follow.

Patient-ventilator asynchrony, a mismatch between what a ventilated patient needs and what the ventilator delivers, is a common and consequential problem in intensive care. It can cause patient discomfort and has been associated with worse outcomes for critically ill patients. Ineffective efforts, in which a patient tries to breathe but the ventilator does not deliver a supporting breath, are the most frequent type of asynchrony. Published research has shown they may affect nearly half of mechanically ventilated patients, and they have been associated with injury of the inspiratory muscles, prolonged time on the ventilator, and difficulty weaning. Because they occur intermittently and can be subtle, ineffective efforts are easily missed during the brief, manual waveform checks performed at the bedside.