- No public price. The site shows no plan, billing period or trial.
- Not disclosed
- Not disclosed
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- UK
Radiology
Caristo Diagnostics
by Caristo · UK
CaRi-Heart measures coronary inflammation on CT angiograms to estimate heart attack risk. CaRi-Plaque analyses coronary plaque.
On this page
21/100Niche fit
- Regulatory & Compliance18/28
FDA cleared (3 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength0/26
No peer-reviewed coverage
- Vendor & Market3/18
Seed-stage or unfunded
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (3 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers0/18
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
CaRi-Heart measures coronary inflammation on CT angiograms to estimate heart attack risk. CaRi-Plaque analyses coronary plaque.
No public price. The site shows no plan, billing period or trial.
Bottom line
Caristo Diagnostics, an Oxford University spin-out, sells CaRi-Heart, software that measures coronary inflammation and cardiovascular risk from a coronary CT angiogram, and CaRi-Plaque for plaque analysis. FDA granted CaRi-Heart a De Novo authorization in July 2026 and cleared CaRi-Plaque in February 2025. Because both work from coronary CTA, they fit cardiology and imaging departments that already run it.
Who is Caristo?
Caristo Diagnostics Ltd is based in Oxford and was founded in 2018 as a University of Oxford spin-out, which the university announced in October 2018 as a firm launching to predict and prevent heart attacks years before they happen. Charalambos Antoniades and Cheerag Shirodaria are among the co-founders. A 2018 seed round of £2 million came with an Innovate UK grant of £1.9 million. The company completed a Series A in April 2023, a further £13 million ($16.3 million), led by Oxford Science Enterprises with BGF and Longwall. BGF says Caristo has raised more than £33 million in total. Stephen Deitsch is named as CEO on the company's site.
Caristo's homepage says CaRi-Heart technology "creates a new paradigm to fight heart attack and other cardiac diseases by uncovering hidden inflammation". It describes CaRi-Heart as "the first and only biomarker to measure coronary inflammation and assess cardiovascular mortality risk".
What does the software measure?
CaRi-Heart derives the FAI-Score, a measure of coronary inflammation, from the CT angiogram and combines it into an individualised risk score. Caristo lists three areas of use: prevention, diagnosis and treatment, and drug development. CaRi-Plaque analyses coronary plaque on the same type of scan.
Which FDA decisions does Caristo hold?
Three decisions are on record:
- DEN250042, CaRi-Heart, De Novo, July 28, 2026 (product code SIU)
- K242240, CaRi-Plaque, February 20, 2025 (product code LLZ)
- K200274, CariCloud, May 21, 2020 (product code LLZ)
Caristo's site confirms the first two, and CariCloud dates from 2020.
What certifications does the company show?
The site displays BSI logos for ISO 9001, ISO 13485 and ISO 27001, with CE (CE2797) and UKCA marks.
How is CaRi-Heart priced?
Caristo gives no figure or trial terms.
The verdict
Caristo is a funded Oxford spin-out with a De Novo authorization for its flagship product and a 510(k) for its plaque tool. A department with coronary CTA volume has the scan the software needs, and a department without it has nothing to run it on.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Quote only | — | — | No public price. The site shows no plan, billing period or trial. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA De Novo, FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
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