- No public price.
- Not disclosed
- Not disclosed
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- KR
Pathology
Deep Bio
by Deep Bio · KR
Gleason grading and prostate cancer detection AI for digital pathology (DeepDx suite), made in Seoul.
On this page
16/100Tracked
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength12.3/28.8
1 peer-reviewed paper
- 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 papers8/21
1 peer-reviewed paper
- RCT / meta-analysis / systematic review4/8
1 observational study (no RCT)
- 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
Gleason grading and prostate cancer detection AI for digital pathology (DeepDx suite), made in Seoul.
No public price.
Bottom line
Deep Bio is a Seoul company whose main product is DeepDx Prostate, software that detects prostate cancer and grades Gleason patterns on whole-slide images of biopsies and surgical specimens. It has Korean Class III approval and an external validation in BJU International. It fits a pathology lab in Korea or Europe that already runs a compatible slide viewer. A US lab has no FDA-cleared version of it to buy.
What is Deep Bio and who sells it?
Deep Bio Inc. has its office in the Guro-gu district of Seoul. A company news item from 19 November 2024 calls it "a leader in artificial intelligence for digital pathology," which is the company's own description. Directories give 2015 as the founding year and Sun Woo Kim as CEO, while no founding date is stated on the homepage. Company news records a seed round in August 2017 and a $5M Series A in March 2018.
Later funding is unclear. Directories put total funding anywhere from $6.7M to $17.9M, and mention a Series B in 2020 and a 2023 round with Gencurix. A Korea Biomedical Review headline reports headcount cuts and a reliance on Roche and PathAI for US sales.
What does DeepDx do?
The DeepDx suite has a viewer, DeepDx Prostate for core needle biopsy, radical prostatectomy and TURP specimens, DeepDx Breast for resections and sentinel node biopsies, and DeepCDx Membrane for IHC. The prostate tool finds cancer and assigns Gleason patterns on scanned slides.
Integration partners announced for the prostate algorithm include Roche navify Digital Pathology, Techcyte, Visiopharm and HALO AP. Techcyte and Visiopharm each issued a press release about the integration.
What is its regulatory status?
South Korea's MFDS granted Class III approval to DeepDx-Prostate Pro in November 2021. Company news lists ISO 13485:2016 from 2018, MDSAP from August 2022 and ISO 27001 from October 2022. Partner pages describe CE-IVD in Europe and research use only elsewhere.
The FDA 510(k) database lists no clearance for Deep Bio as of October 2026, and the Techcyte platform is research use only in the US. Paige Prostate, by contrast, holds an FDA De Novo authorization. The company's site lists ISO 27001 but makes no HIPAA or SOC 2 statement, which matters for a lab sending biopsy slides to an outside vendor.
Has DeepDx Prostate been validated externally?
Yes, once. A 2025 paper in BJU International externally validated DeepDx Prostate for Gleason grading on prostatectomy specimens and names the tool.
How much does it cost?
The company lists no price.
Who is it for?
A Korean or European pathology lab that reads prostate biopsies and already licenses navify, Techcyte, Visiopharm or HALO. A US lab that needs FDA-authorized prostate AI is a better match for Paige.
The verdict
Deep Bio has one externally validated prostate algorithm and a Class III approval in Korea. Directories disagree on its total funding by more than $11M. For prostate AI in the US, Paige holds the authorization and Deep Bio does not.
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 |
|---|---|---|---|
| Enterprise | — | — | No public price. |
Source: vendor pricing page. Last checked October 15, 2026.
What the literature says
1 peer-reviewed study indexed on PubMed evaluate Deep Bio in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- External validation of an artificial intelligence model for Gleason grading of prostate cancer on prostatectomy specimens.
- Schmidt B, Soerensen SJC, Bhambhvani HP, et al.· BJU Int· 2025
- To externally validate the performance of the DeepDx Prostate artificial intelligence (AI) algorithm (Deep Bio Inc., Seoul, South Korea) for Gleason grading on whole-mount prostate histopathology, considering potential variations observed when applying AI models trained on biopsy samples to radical prostatectomy (RP) specimens due to inherent differences in tissue representation and sample size. The commercially available DeepDx Prostate AI algorithm is an automated Gleason grading system that was previously trained using 1133 prostate core biopsy images and validated on 700 biopsy images fro…
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