ROADMAP

Clear milestones to FDA clearance

and commercial scale.

From a wearable-ready system to regulated clinical deployment —

the stages that take Sonologi from validation to scale.

H1 2026

Product readiness

Finalize wearable ultrasound system and disposable patch

Complete design verification and manufacturing readiness

H2 2026

Clinical validation

Conduct clinical studies in high-acuity cardiac settings

Generate evidence with leading clinical partners

LATE 2026

FDA submission

Complete regulatory documentation

Submit for FDA clearance

TARGET 2027

FDA CLEARANCE

Regulatory decision and initial launch

Obtain FDA clearance

Launch at selected reference hospitals

Begin limited commercial deployment

2027–2028

Commercial scale

Expand across ICU, CCU, and post-discharge HF settings

Scale toward 10,000 deployed devices

From clinical validation to FDA clearance and commercial scale.