Autonomous Healthcare Receives FDA De Novo Marketing Authorization for Syncron-E Ventilator Waveform Analysis Software
Autonomous Healthcare has received FDA De Novo marketing authorization for Syncron-E, a software that aids respiratory therapists in detecting patient-ventilator asynchrony caused by ineffective efforts during mechanical ventilation, and is the first device in a newly created FDA device category for ventilator waveform analysis software, now classified as a Class II medical device in the U.S. for adults 22 years and older on invasive mechanical ventilation, supported by multi-site clinical data and designed to automate waveform analysis while not replacing clinical judgment.
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Autonomous Healthcare Receives FDA De Novo Marketing ...
Autonomous Healthcare — Intelligent Systems for Critical Care
Device Classification Under Section 513(f)(2)(De Novo)
Device Classification Under Section 513(f)(2)(De Novo)
Device Classification Under Section 513(f)(2)(De Novo) - FDA
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