Automated software enables respiratory therapists to detect ineffective breathing efforts, the most common form of patient-ventilator asynchrony among mechanically ventilated patients.
Autonomous Healthcare has received FDA De Novo marketing authorization for Syncron-E™, a software solution designed to help respiratory therapists assess patient-ventilator asynchrony by identifying ineffective breathing efforts. The authorization creates a new FDA device category, ventilator waveform analysis software, making Syncron-E the first approved product in this classification and establishing a regulatory pathway for future technologies in the field.
Patient-ventilator asynchrony occurs when there is a mismatch between a patient’s breathing needs and the support provided by a ventilator. Common in intensive care settings, this condition can lead to patient discomfort and has been linked to poorer outcomes among critically ill patients.
One of the most common forms of asynchrony is ineffective effort, where a patient attempts to breathe but the ventilator fails to provide a corresponding breath. Studies suggest that nearly half of mechanically ventilated patients may experience ineffective efforts, which have been associated with inspiratory muscle injury, extended ventilation periods, and challenges during the weaning process.
Because these events can be intermittent and difficult to detect, they are often overlooked during routine bedside waveform assessments, highlighting the need for advanced monitoring and analysis tools.
Syncron-E was developed to address this challenge by automatically analyzing previously recorded ventilator waveform data and presenting summarized findings for respiratory therapists to review. The software replaces time-consuming manual assessments with a structured and automated approach for identifying evidence of ineffective efforts, the most common form of patient-ventilator asynchrony. Its performance is supported by data collected across multiple healthcare sites.
“The FDA De Novo authorization marks a significant milestone for Autonomous Healthcare and reflects years of innovation and development,” said Behnood Gholami, PhD, Co-Founder and CEO of Autonomous Healthcare. “By establishing a new device category, we are bringing clinicians access to tools that were previously unavailable. Syncron-E represents the first step in our broader vision of delivering intelligent and increasingly autonomous technologies for intensive care and other healthcare settings.”
“Patient-ventilator asynchrony is a common challenge in intensive care units, but its intermittent nature and the demands placed on respiratory therapists can make it difficult to detect,” said James M. Bailey, MD, PhD, Chief Medical Officer of Autonomous Healthcare. “Identifying the problem is the first step toward effective management, and we believe Syncron-E can play an important role in improving recognition and patient care.”
Syncron-E is designed as a clinical support tool for respiratory therapists, enabling the analysis of previously recorded ventilator waveform data from adult patients aged 22 years and older who are receiving invasive mechanical ventilation. The software helps identify evidence of ineffective breathing efforts and, following FDA De Novo authorization, can now be marketed in the United States as a Class II medical device.
Autonomous Healthcare plans to introduce Syncron-E into clinical practice while continuing to expand its portfolio of advanced technologies aimed at improving critical care and other healthcare settings.
About Autonomous Healthcare:
Autonomous Healthcare is developing advanced healthcare technologies designed to improve patient outcomes through greater automation in clinical care. The company leverages innovations in machine learning, artificial intelligence, and closed-loop control systems to create intelligent solutions for healthcare providers. Syncron-E is the first Autonomous Healthcare product to receive FDA marketing authorization, marking a significant milestone in the company’s mission to transform patient care. For more information, visit autonomoushealthcare.com.
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