Santa Clara's Autonomous Healthcare received FDA De Novo authorization on June 18, 2026 for Syncron-E, software that flags patient-ventilator asynchrony breath by breath — and in doing so created an entirely new Class II device category. No venture funding has been disclosed.

The FDA granted De Novo marketing authorization to Santa Clara-based Autonomous Healthcare Inc. on June 18, 2026 for its Syncron-E ventilator waveform analysis software — carving out an entirely new Class II medical device category and making Syncron-E the first cleared product in that class. The authorization (DEN250025, per the FDA De Novo database), filed June 23, 2025 and decided roughly a year later, sets the regulatory predicate that future competitors will need to reference for any 510(k) clearance.

Syncron-E reviews ventilator pressure and flow waveforms breath by breath, flagging patient-ventilator asynchrony — moments when a patient's breathing efforts go unsupported by the machine, a problem that can slip past stretched ICU staff. "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," CMO James M. Bailey, MD, PhD said in the company's PR Newswire release announcing the clearance.

The cap table is opaque. No Form D for a venture round appears under "Autonomous Healthcare" in SEC EDGAR. The only traceable public funding is a $1.9M NIH grant for a separate pharmacy workflow project, per a prior PR Newswire release. The company — founded around 2013, per industry databases, incorporated in Delaware in 2016 — disclosed no outside investment alongside this clearance. Co-founders Wassim M. Haddad (President and CEO, per the announcement) and Behnood Gholami (CTO, and the named contact on the FDA filing) have not announced a raise.

Who is backing the commercial push into hospital systems, and whether any venture round is in progress, remain undisclosed.