Overview
Prolaio builds cardiovascular clinical research infrastructure that turns homes into trial sites using medical-grade wearables to capture continuous real-world heart data. Its intelligence engine converts these signals into clinically robust endpoints and FDA-cleared digital biomarkers, supporting recruitment, 24/7 data capture, adaptive analytics, and trial dashboards. The platform enables fully managed real-world trials as well as digital enablement of existing protocols and post-discharge monitoring, with dozens of validated algorithms including FDA-cleared measures across 20+ countries. The goal is to make cardiovascular trials faster, more scalable, and more accurate by using home-based data and standardized digital endpoints.
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Simplify's take
What believers are saying
- Kardigan's August 11, 2026 results credit Prolaio for three late-stage programs, proving internal dependence.
- Prolaio's FDA-cleared eVO2peak and AFib burden strengthen cardiovascular endpoint differentiation immediately.
- New Prolaio strategy and customer-success roles in 2026 signal active commercialization, not shutdown.
What critics are saying
- Kardigan controls Prolaio now, so standalone SaaS independence ended by September 2026.
- Prolaio still shows customer-success hiring in 2026, signaling heavy services burden and margin pressure.
- Competitors like Medable, ActiGraph, and Biofourmis sell broader decentralized-trial stacks and unbundle Prolaio's niche.
What makes Prolaio unique
- Kardigan bought Prolaio on March 27, 2025, bundling data with therapeutics.
- Prolaio runs FDA-cleared cardiovascular biomarkers from 4 million on-body hours across 26 countries.
- Its platform converts home wearables into trial endpoints, dashboards, and structured regulatory data.
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