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Bioscience Company Member
Helia Diagnostics LLC
Organization Overview
Helia Diagnostics is a life sciences company developing HeliaDX, an AI-assisted medical device that improves the accuracy of adult autism evaluations. Adults are
evaluated for autism every day, but the tools clinicians rely on depend on observing behavior — and masking, the learned suppression of autistic presentation,
conceals the very behavior the evaluation depends on. The result is a systematic failure: the adults who adapted best are the most likely to be missed, a
population increasingly recognized as the "Lost Generation" of autistic adults identified late or not at all. HeliaDX operates during a standard clinical evaluation,
applying multimodal physiological signal processing to measure the physiological cost of masking. It gives clinicians objective evidence where they currently
have only observation and inference, functioning as decision support that complements — rather than replaces — clinical judgment. Helia Diagnostics is pre-MVP
and pursuing FDA De Novo classification, which would establish HeliaDX as the first cleared technology of its kind. The company operates in Virginia, holds a
research affiliation with Virginia Commonwealth University providing an IRB pathway, and is preparing an NIH STTR Phase I application, in partnership with the
Institute for Human and Machine Cognition, for January 2027.
evaluated for autism every day, but the tools clinicians rely on depend on observing behavior — and masking, the learned suppression of autistic presentation,
conceals the very behavior the evaluation depends on. The result is a systematic failure: the adults who adapted best are the most likely to be missed, a
population increasingly recognized as the "Lost Generation" of autistic adults identified late or not at all. HeliaDX operates during a standard clinical evaluation,
applying multimodal physiological signal processing to measure the physiological cost of masking. It gives clinicians objective evidence where they currently
have only observation and inference, functioning as decision support that complements — rather than replaces — clinical judgment. Helia Diagnostics is pre-MVP
and pursuing FDA De Novo classification, which would establish HeliaDX as the first cleared technology of its kind. The company operates in Virginia, holds a
research affiliation with Virginia Commonwealth University providing an IRB pathway, and is preparing an NIH STTR Phase I application, in partnership with the
Institute for Human and Machine Cognition, for January 2027.
Bioscience Company Member