Our FDA comment on AI in early-phase trials
ABOUT

We're building the layer between biosignals and care. Neutral. Grounded. Governed. Accountable.

AnyBio started with a simple observation: monitoring produces more data than care teams can act on, and nobody has made it safe for software to speak to the patient. The governed agentic layer between the signal and the people it's meant to help is the missing infrastructure. That's what we're building.

Where it started.

I kept watching promising digital health programs hit the same wall. Not the idea. Not the clinical intent. The operational layer underneath — integration, provenance, compliance, workflow wiring. The 'non-differentiating' pieces that decide whether a product actually scales. AnyBio is the layer I wanted to exist.
Stephen Saine
Stephen SaineCEO & Founder, AnyBio
OUR MISSION

Make health AI deployable in regulated care.

We run the biosignal infrastructure: the layer health AI runs on, grounded in the signal and carried all the way to the chart. Signal is captured at the source, anything that runs on it runs inside a governed envelope, and the result is delivered into the record with its provenance intact. We author no model of our own, deliberately: bring yours, or start with an open one.

WHY NOW

AI changes the equation.

AI is getting more capable faster than anyone planned for, and the bottleneck in care isn't the intelligence, it's whether a hospital can trust it near a patient. The scarce thing isn't another model; it's the governed layer that can run them safely. That's where we sit, and it gets more necessary, not less, as AI improves.

OUR VALUES

What we believe.

Infrastructure enables innovation. We do not compete with it.

We are the layer beneath the product. Our job is to make care teams more effective and the people building for them faster. If we are not measurably reducing time to launch, engineering burden, or clinical noise, we are not doing our job.

Trust is the product.

In healthcare, infrastructure must be governed, auditable, secure, and explainable. Compliance is not overhead — it is a core feature. We treat it that way.

AI needs guardrails.

AI in healthcare must be held to a higher standard. Every AI output on our platform is logged, explainable, PHI-safe, and bounded, with the clinically consequential decisions surfacing to a human. We built governance in because healthcare demands it.

Differentiation belongs to builders.

Algorithms, protocols, care models, and product IP stay with the people who created them. Always.

The stack gets more powerful. The trust layer has to keep up.

Biosignals and AI are getting more capable every year. The infrastructure underneath has to keep pace — more auditable, more explainable, more trustworthy. We're building for that.

ADVISORY BOARD

Strategic & Clinical Advisory Board

A group of clinical, product, and go-to-market leaders helping us build the governed layer between biosignals and care.

Kenneth Civello, MD, MPH

Kenneth Civello, MD, MPH

Cardiologist & Electrophysiologist

Kenneth Civello, MD, MPH, is a cardiologist, electrophysiologist and Chief of Electrophysiology at FMOL Health. He trained in internal medicine at Vanderbilt University and completed his cardiology fellowship at The Cleveland Clinic. Remote monitoring is his daily practice. His electrophysiology service follows patients through implanted cardiac devices and wearables between visits, and his research and writing focus on the operational side of remote physiologic monitoring.

LinkedIn
Piotr Zając

Piotr Zając

HealthTech Director, Monterail

Piotr Zając is HealthTech Director at Monterail. For 14 years, his team built the regulated software and device connectivity behind wearables for clients like Elvie and Eargo, and he joined Monterail when it acquired his firm, Untitled Kingdom, in 2024.

LinkedIn
Kalin Stanojev

Kalin Stanojev

AI Strategy & Platform, SafeRide Health

Kalin Stanojev leads AI strategy and platform at SafeRide Health, where he is helping shape how AI transforms the company's operations, products, and ability to serve the healthcare transportation and logistics market at scale. A former founder with deep product and technology leadership experience, he has spent the last decade building leading-edge applied AI systems that turn rapid innovation into scalable business value, with accountability and control built in by design.

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Laurent Castaillac

Laurent Castaillac

Go-to-Market Advisor

Laurent advises AnyBio on go-to-market strategy, enterprise sales, and revenue growth, drawing on more than 20 years of enterprise SaaS sales leadership. An early enterprise hire at Marketo, he helped scale it past $350M ARR before Adobe's acquisition and later served as VP of Enterprise Sales, then built go-to-market organizations at Near Intelligence and Sendoso. He is a Limited Partner at Stage 2 Capital and advises early-stage AI and enterprise SaaS founders.

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Seth Bain

Seth Bain

Story & Design Strategist

Seth is a serial entrepreneur with multiple exits, currently working with start-up and mission-driven leaders to create things that help improve and repair the world. He uses strategy, storytelling and design to align organizations, build brands and connect people.

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We're building the rails. Come build on them.

Teams building health products, care and RPM platforms, providers and research teams, plus the device and algorithm partners who run on the same rails: we'll walk through where you fit.

Moving forward together