Healthesis.AI

Automate MedTech evidence work.

Turn the documents you upload into a cited evidence report in minutes — the first-pass work that usually burns analyst hours and specialist fees. A pitch deck is enough to start, and you can add data-room files, studies, notes, and other company documents at any time. Founders close gaps before fundraising; investors verify claims and assess risk.

Founder Readiness Investor Diligence See pricing

Professional research automation for MedTech and HealthTech teams.

Desk with a diligence report open on a laptop beside a pitch deck and clinical notes

Two sides, one engine

Mutual information where founder and investor evidence intersects

Built for MedTech and HealthTech — not a general-purpose diligence tool.

Founder Readiness

Identify and resolve evidence gaps before fundraising. Get a prioritized roadmap of documents, studies and claim corrections to close.

Start as a founder

Investor Diligence

Independently verify claims and assess investment risk. Find material gaps and questions for management before committee.

Start as an investor

How it works

From your documents to a cited evidence report in three steps

Automate the collection and cross-check; keep your time for judgement.

Step 01
Add the company
Upload the documents you have — a pitch deck, data-room files, studies, or notes — or start from the company website. You can add more later.
Step 02
Healthesis.AI runs the first pass
Claims are extracted, cross-checked and structured into a cited report — typically in about 8 minutes.
Step 03
Act on the gaps
Founders close them; investors pressure-test them. Export PDF or Word when you are ready to share.

Healthesis concise brief UI for the fictional sample company Kalmira Vision — Product UI · Concise brief · Kalmira Vision (fictional sample)

What's in the report

Evidence across the areas that decide MedTech deals

Eight diligence areas in one Concise brief and full In-depth report — framed as Founder Readiness or Investor Diligence.

Healthesis in-depth report UI with key facts and cited diligence sections for Kalmira Vision — In-depth report · same fictional sample run

Regulatory
Clinical
Technical
IP
Commercial
Market sizing
Financial
Team

Coverage

Built for the MedTech / HealthTech surface area

Classes and pathways for the markets with a rule pack, and the public records each check uses.

Device classes, pathways, and registries by market
	United States	EU / EEA	United Kingdom	Canada	Wellness, no health claim, care or telehealth
Class	I, II, III	I, IIa, IIb, III. IVD: A, B, C, D	I, IIa, IIb, III. Northern Ireland: A–D for IVDs	I, II, III, IV	Not applicable
Pathway	510(k), 510(k)-exempt, De Novo, PMA	CE marking: self-declaration or Notified Body	UKCA: self-declaration or Approved Body. CE marking still accepted for a transition period	Class I: MDEL only. Class II–IV: Medical Device Licence	Not applicable
Registry checked	openFDA: 510(k), PMA, classification, recalls, MAUDE. De Novo is checked by hand	EUDAMED	MHRA PARD	Health Canada MDALL	Not applicable

The same run also checks ClinicalTrials.gov, Europe PMC, CMS coverage and HCPCS codes, SEC Form D, the GLEIF company index, and patent records. The report names a class from the claims. It does not issue a classification.

Why teams use it

Automation that replaces days of first-pass work

Compress analyst time and early specialist rounds into a reusable evidence package.

Minutes, not days

A full first-pass evidence run typically finishes in about 8 minutes — work that often takes a full analyst cycle.

Fewer early consults

Arrive at counsel or specialist review with a structured, cited package instead of a raw deck and scattered notes.

One shared package

Founders and investors work from the same evidence engine — close gaps or pressure-test them without rebuilding the file.

Pricing

Simple pricing for founders and investors

Every analysis run counts as one report. An additional report is $19. Prices in USD; taxes may apply.

Founder

$99per month

5 reports / month

Fundraising readiness + evidence gap analysis
Open registration
Subscribe before the first analysis

Create account

Investor

$199per month

10 reports / month

Independent diligence support + risk analysis
Open registration
Subscribe before the first analysis

Create account

Full pricing details and what counts as a report

FAQ

Questions founders and investors ask us

Who is Healthesis.AI for?

MedTech and HealthTech founders preparing to raise, and professional investors who screen those companies. Both use the same evidence engine: founders get a readiness roadmap, investors get an independent diligence brief. It is a professional tool for business use.

What do I need to start?

A pitch deck is enough for a Level 1 assessment: claim extraction, independent public research, and a prioritized evidence-gap roadmap. That is a rigorous first pass — not completed full due diligence. Add clinical, regulatory, financial or IP documents to deepen to Level 2, then reassess as new evidence arrives (Level 3). Version history shows what changed.

How long does an analysis take?

A full analysis typically takes about 8 minutes, depending on the size of the documents and how many markets you select — work that often costs days of analyst or consultant time.

What product types and markets are covered?

Built for MedTech and HealthTech across SaMD and health software, hardware, IVDs, combination products, care services, and wellness vs disease claims. Regulatory pathway coverage includes the United States, EU/EEA, United Kingdom and Canada.

What happens to my documents?

Your documents are stored privately in your workspace and processed only to provide the service. Please do not upload patient-identifiable health data. See the Privacy Policy and Security pages.

Is there a free trial or a team plan?

Founder and Investor are paid monthly subscriptions for one workspace. There is no free trial. Team plans are not available yet.