Merck · Preclinical research
A stronger foundation for AI in toxicology.
Curated reference data and reproducible workflows for MicroCT segmentation.
Explore Merck’s story ↗Expert-led. Platform-powered.
Clinical AI.
Connected validation.
Clinical validation, revalidation and post-market monitoring—across teams, products and versions.
Managed by our experts. Connected by our platform.
CB Insights AI 100 2024 selection ↗The Gesund approach
Infrastructure for clinical AI evidence.Explore the modules →
Customer experience
Customer stories
Clinical evidence.
Regulatory success.
Our platform, data and clinical expert services supported the evidence behind FDA clearances for Computer Vision and Prenuvo. Explore those milestones alongside Merck’s preclinical research.
Computer Vision / Emeralgo
From first clearance to the next version.
Clinical evidence for lumbar-spine AI. A continuing relationship across updates and new products.
Explore the relationship ↗Prenuvo · Body Composition AI
Clinical evidence. Real-world use.
Expert validation supporting clearance for an AI product now offered in clinical care.
Explore Prenuvo’s story ↗Managed clinical validation
We bring the
moving parts together.
- 01
Data
Source, license and curate through clinical partnerships.
- 02
Models & versions
Register models and run inference on the study cohort.
- 03
Clinical annotation
Coordinate physician annotation, review and adjudication.
- 04
Study execution
Run the agreed protocol against the expert reference.
- 05
Connected evidence
Trace results to the data, model version and protocol.
Expert reference workflow
The platform behind the service
A control tower for
your AI evidence.
Keep clinical, data science, RA/QA and product teams connected to the same version-specific evidence.
See how the work connects ↗ClinicalData scienceRA / QAProduct
Shared evidence baseProduct · Model version · Data · Reference · Protocol · Result
ValidateRevalidateMonitor
From first study to what comes next
Create it. Keep it connected.
Clinical validation
Evidence for your intended clinical use.
Execute the initial study ↗Revalidation
Evaluate changes as products evolve.
Evaluate the next version ↗Post-market monitoring
Monitor live performance. Investigate and act.
Monitor performance ↗Governance carries through every stage. Explore change evaluation under an FDA-authorized PCCP, where applicable ↗
The broader ecosystem
Built with expertise.
Backed with conviction.
Recognition & perspectives
A voice in the conversation.
First Opinion · January 9, 2023Four types of bias in medical AI are running under the FDA’s radar
Read the opinion at STAT+ ↗Selected · 2024AI 100CB InsightsView recognition ↗First Opinion · January 3, 2025How to bring more trust and transparency to clinical AI
Read the opinion at STAT+ ↗
Reported coverage · February 24, 2022Gesund’s early validation mission
Read the coverage ↗GesundSignalRegulated AI.
Regulated AI.
In perspective.
Market intelligence on regulation, research, adoption and the companies shaping healthcare AI. Clear sources. Actionable context for your next product and regulatory decision.
Explore Gesund Signal →01Track the market.Regulation, research, adoption and companies.
02Understand what matters.Sources, context and competing explanations.
03Make a better-informed move.Inform your next product and regulatory decision.
Latest · From Lag to Live: The FDA's Real-Time Clinical Trial Initiative and What It Means for Health AI
Your next milestone
What does your AI
need to prove?
Start with your product, timeline and clinical evidence question.
Discuss your study ↗Define the work with Gesund.