AI Clinical Software. Decoded.
Strategic intelligence for investors assessing regulated AI clinical software startups and scaleups.
What is registered, where, and under which claim. What the public record does not cover. And what to ask the company before you decide.
Request a Target AssessmentBuilt for
Investors and corporate teams assessing regulated AI clinical software companies.
Venture investors
Get the regulatory picture on a company you are already looking at, before the committee date.
Corporate development
Separate what a target has actually registered from the claims made in its investor deck.
Strategy teams
Check whether the companies in your segment hold the approvals they publicly claim.
Investor use cases
Turn fragmented company data into investment-relevant questions.
Screen companies faster
Multiple official registries, one company, one readable answer — in days rather than weeks.
Assess execution risk
Separate what is registered and verifiable from what is only claimed commercially.
Prioritize diligence
Know what the public record leaves open, and what to ask the founders about it.
The Target Assessment
One company. Five sections. Five working days.
The registered record
Company and product registrations across the US, EU, UK, Canada and Singapore. Product classification and the regulatory pathway actually taken. Certificates, their scope and validity. Importers, distributors and authorised representatives.
Claim consistency
Where the commercial claim goes further than the claim the regulatory file authorises. Flagged when found — not every company has a gap.
Registered clinical evidence
Trials on file: sponsor, status, design, enrolment, number of sites, dates, and whether results were posted.
Questions for the company
What the public record does not cover, turned into specific questions to put to the founders before you commit.
Overall analysis
A written read across everything above, based on professional judgment. Non-binding, and not an investment recommendation.
How it is built
Every assessment starts from a monitored company base, not a blank page.
Regulatory, clinical and market records are collected continuously and structured into comparable company profiles. That base is the production tool behind each report — it is what makes a five-day turnaround possible.
Company profile
Why now
AI clinical software is becoming harder to assess.
Regulated AI clinical software companies are shaped by more than technology. Their value depends on regulatory maturity, clinical evidence, intended use, market segment, and real-world adoption signals.
For investors, these signals sit scattered across separate regulatory registries, written in regulatory language and easy to misread. Cobalt Oak collects them, reads them, and returns a single assessment on the company you are looking at.
Methodology
Built from official public records.
Cobalt Oak assembles publicly available regulatory, clinical, and market records — then reads and interprets them for the company under assessment.
Continuous monitoring of official regulatory and clinical registries across the US, EU, UK, Canada, LATAM, and APAC
Regulatory record
Registrations, product classification, pathway taken, certificates and scope, economic operators.
Clinical record
Registered trials, design and status, enrolment and sites, posted results, published evidence.
Market record
Stage, segment, geography, operational status, and where the company is commercially present.
Coverage
The monitored base behind every assessment.
Coverage is updated as new public regulatory and clinical signals are identified.
Startups and scaleups monitored
Countries covered
AI clinical software segments
Regulatory and clinical sources tracked
What is tracked per company
Name, website, country, stage, operational status.
Primary segment, clinical area, target setting, software category.
Registrations, classification, pathway, certificates, economic operators.
Registered trials, design and status, posted results, source links.
Built from experience across AI clinical software, medical device regulation, and digital health strategy.
Target Assessment
Get the regulatory picture before you commit.
Send the company name and your decision timeline. You get an answer within one business day on whether the public record supports a useful assessment — with price and delivery date.
Request a Target AssessmentCobalt Oak assessments are based on publicly available information as of the report date. They are non-binding and do not constitute investment, legal, regulatory, or medical advice.