- No public price. The site shows no plan, billing period or trial.
- Not disclosed
- Not disclosed
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- SE
Pathology
ContextVision INIFY
by ContextVision · SE
Image-enhancement software for imaging makers. Its INIFY Prostate biopsy AI is CE-marked (2020) but a 2025 review credits it to Inify Laboratories.
On this page
5/100Tracked
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength0/28.8
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 clearance0/18
No FDA clearance listed
- 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 papers0/21
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
Image-enhancement software for imaging makers. Its INIFY Prostate biopsy AI is CE-marked (2020) but a 2025 review credits it to Inify Laboratories.
No public price. The site shows no plan, billing period or trial.
Bottom line
INIFY Prostate Screening is an AI tool for reading prostate core needle biopsies on digital pathology slides, CE-marked since 2020. ContextVision, the Stockholm company that announced it, is mainly an image-enhancement supplier to ultrasound, X-ray and MRI makers. A 2025 review lists the product under a separate Swedish company, Inify Laboratories. No price is public.
What is INIFY, and who sells it?
ContextVision AB describes itself as a medical technology software company specialised in image analysis and artificial intelligence, and a "global market leader in image enhancement" for ultrasound, X-ray and MRI manufacturers. The market-leader line is the company's own. It was established in 1983, sits at Gamla Brogatan 26 in Stockholm and is listed on the Oslo Stock Exchange as CONTX.
On 29 June 2020 ContextVision announced INIFY Prostate Screening as its first CE-marked digital pathology product, per GlobeNewswire. The software screens whole-slide images of prostate core needle biopsies. ContextVision's own website does not mention INIFY.
A 2025 review in PubMed Central, PMC12101047, lists "Inify Prostate" from Inify Laboratories of Sweden as CE-IVD marked and gives no performance claims. The review does not say how Inify Laboratories relates to ContextVision.
What does the regulatory record show?
The CE mark dates from June 2020. In the US, the FDA's 510(k) records contain no entry for INIFY. The only ContextVision entries are two much older image-enhancement clearances filed under the spelling "Context Vision", K993802 in January 2000 and K024028 in January 2003, both for SharpView enhancement and unrelated to pathology.
How does it compare with other prostate pathology AI?
Ibex has one 510(k) for prostate, K241232 for Galen Second Read (Ibex Prostate Detect), decided on 24 January 2025, according to the FDA's 510(k) records. Ibex First Read for prostate is CE marked under IVDR, per Ibex's own solutions page. INIFY has a CE mark from 2020 and no US clearance.
Which laboratories is it for?
A European pathology laboratory that scans its slides and wants an AI second look at prostate biopsies. A US laboratory has no cleared route to it.
The verdict
INIFY suits a European laboratory that accepts a CE-IVD product from 2020. Ownership of the contract and the regulatory file sits with either ContextVision or Inify Laboratories, and the 2025 review points to the latter. A laboratory that needs a US-cleared prostate tool cannot use INIFY, and the prostate clearance cited above belongs to Ibex.
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 CE mark (INIFY Prostate Screening, 2020) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
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