PRODUCT · MECHANICAL VENTILATION
Syncron-E™
Waveform intelligence for mechanical ventilation.
FDA De Novo Granted
Waveform intelligence for mechanical ventilation.
Detecting it depends on a clinician being at the bedside at the right moment, reading subtle waveform patterns. In a busy ICU, most events go unseen.
Syncron-E analyzes pressure and flow waveforms breath by breath, flagging ineffective efforts, the most frequent type of patient-ventilator asynchrony, for the respiratory therapist to review. An ineffective effort occurs when a patient tries to breathe but the ventilator does not deliver a supporting breath.
Syncron-E draws on years of peer-reviewed research in ventilator waveform analysis.
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 efforts. It is not intended for use in time-sensitive scenarios and does not replace clinical judgment.
Syncron-E is authorized for marketing in the U.S. through the FDA De Novo classification process as a Class II medical device. Caution: Federal law restricts this device to sale by or on the order of a physician.
Syncron-E™ is the first system granted FDA marketing authorization for detecting ineffective efforts, the most frequent type of patient-ventilator asynchrony.
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