Clear milestones to FDA clearance and commercial scale.
From a technology-ready platform to clinical impact
Q1 2026
Product readiness
Finalize wearable ultrasound system and disposable patch
Complete design verification and manufacturing readiness
Q2 2026
Clinical validation
Conduct clinical studies in high-acuity cardiac settings
Generate evidence with leading clinical partners
Q4 2026
FDA submission
Complete regulatory documentation
Submit for FDA clearance
2027
FDA clearance
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.