Autonomous Healthcare Receives FDA De Novo Marketing Authorization for Syncron-E™, the First Device in a New FDA Category of Ventilator Waveform Analysis Software

Automated software helps respiratory therapists identify ineffective efforts, the most frequent type of patient-ventilator asynchrony in mechanically ventilated patients

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.

Syncron-E was built to close that gap. The software analyzes previously recorded ventilator waveforms and summarizes the findings for a respiratory therapist to review, replacing a manual task with a structured, automated way to detect evidence of ineffective efforts, the most frequent type of patient-ventilator asynchrony. Syncron-E is supported by multi-site performance data.

"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 of Autonomous Healthcare. "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."

"Asynchrony is a very common problem in the ICU, yet because it is intermittent and respiratory therapists care for many patients at once, it often goes unrecognized. Recognition is the first step in managing any clinical problem, and we believe Syncron-E will help change that," said James M. Bailey, MD, PhD, Chief Medical Officer of Autonomous Healthcare.

Syncron-E is an adjunctive aid intended for respiratory therapists to analyze previously recorded ventilator waveform data from adult patients 22 years and older receiving invasive mechanical ventilation, to detect evidence of ineffective effort. With this De Novo grant, Syncron-E may now be marketed as a Class II medical device in the United States.

Autonomous Healthcare is now bringing Syncron-E into clinical practice and plans to continue expanding its platform of technologies for critical care and beyond.

About Autonomous Healthcare

Autonomous Healthcare is pioneering the next generation of intelligent technologies for healthcare, with the goal of reducing morbidity and mortality by introducing increasing levels of automation into clinical care. Across its broader portfolio, the company draws on advances in machine learning, artificial intelligence, and closed-loop control. Syncron-E is the company's first device to receive FDA marketing authorization. For more information, visit autonomoushealthcare.com.

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Syncron-E™ has been granted marketing authorization as a Class II medical device in the U.S. Federal law restricts this device to sale by or on the order of a physician.

SOURCE Autonomous Healthcare