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Bring your diagnostic
to market faster.

PixoTech® is a technology-service platform — we provide imaging algorithms, hardware analyzers, a cloud data platform and a regulatory path. You focus on your reagents or your business; we handle all the rest of the technical development. From XLab co-development to CDMO manufacturing, a proven path to commercialization.

ISO 13485
Quality system
510(k)
FDA experience
100+
Patents licensable
Remote
XLab co-development
PixoTest Vision platform
01 / Audience Who it's for

Who we
work with.

Whether you have mature strip chemistry, a health brand about to launch, or an academic research prototype — PixoTech® has a partnership path for you.

01 · TEST STRIP DEVELOPERS

Medical-device companies

You have a unique strip formulation but lack clinical-grade algorithms, an analyzer, cloud integration and regulatory-filing capability. We provide full technical support so your strip skips 3–5 years of engineering.

Typical cases
  • Medical-device manufacturers
  • Biochemical strip developers
  • Emerging-biomarker validation
02 · HEALTH &PHARMA BRANDS

Health & pharma brands

You want to launch your own-brand home-testing product, or a companion diagnostic for an existing drug. We customize the UI, app and cloud dashboard so the whole product carries your brand.

Typical cases
  • OTC health brands
  • Pharma companion-Dx programs
  • Pharmacy-chain private labels
03 · RESEARCH INSTITUTIONS

Research & clinical institutions

Clinical trials, epidemiology, large-scale screening — you need a reliable, scalable point-of-care testing solution. The XLab remote co-development model customizes rapidly for different biomarkers and shortens the validation cycle.

Typical cases
  • Clinical-trial investigators
  • Public-health screening programs
  • Academic prototype validation
02 / Model Partnership model

You bring the goal.
We handle the rest.

PixoTech® is a modular technology platform. You decide the assay you want — the rest, from capture and analysis to storage and compliance, is delivered by us.

PixoTech® Co-development Model

Modular Stack · Shared IP
YOUR SIDE Strip chemistry YOUR STRIP IXENSOR PROVIDES Image capture CAMERA + LIGHT Algorithm modeling ML + COLORIMETRIC Cloud data HIPAA-GRADE Regulatory support FDA / CE / TFDA OUTCOME SHARED PRODUCT Your branded smart diagnostic · Cloud-connected · Regulator-ready TIME-TO-MARKET ↓
You bring
  • Your unique strip chemistry / biochemistry
  • End brand & market channels
  • Clinical relevance of the target biomarker
iXensor provides
  • PixoTech® image capture & ML algorithms
  • Analyzer hardware (Vision / Mobile / BT)
  • Cloud data platform & app integration
  • FDA / CE / TFDA regulatory support
03 / Capabilities Capabilities

From concept to
production.

Full CDMO capability — six interlocking technical modules. Take the whole turnkey delivery, or just the pieces you need.

01 · ALGORITHM

Imaging algorithms

Intelligent colorimetric sensing and machine learning — custom qualitative / semi-quantitative / quantitative models for your strip, improving accuracy through continuous learning.

Computer Vision ML Colorimetric
02 · HARDWARE

Hardware integration

From a dedicated analyzer to a Bluetooth device, three PixoTech® forms to choose by use case, produced in certified plants with full quality control.

Vision Mobile BT
03 · CLOUD

Cloud data platform

PixoHealth Hub handles data capture, dashboard generation and API integration — with built-in HIPAA-grade security and a GDPR-compliant data framework.

HIPAA GDPR API
04 · APP

App & user interface

A white-labelable iOS / Android app, or SDK integration into your existing app. Includes standard modules for trends, reminders, AI guidance and educational content.

iOS Android SDK White-label
05 · REGULATORY

Regulatory support

510(k), CE-IVD and TFDA filing experience — clinical-trial design consulting, technical-file preparation and audit-response support across markets.

FDA 510(k) CE-IVD TFDA ISO 13485
06 · MANUFACTURING

Manufacturing & delivery

An ISO 13485-certified supply chain — from PCB design, enclosure molding and assembly testing to global logistics — delivering your branded product end to end.

ISO 13485 GMP Global logistics
04 / Process Engagement timeline

From first contact
to launch.

Four stages, each with clear deliverables and timeline expectations. This is the typical rhythm of a CDMO partnership — actual timing varies with biomarker complexity.

01·

Feasibility / NDA

Start the conversation, sign an NDA, exchange strip samples and initial specs. The iXensor team assesses compatibility between your biomarker and the PixoTech® algorithm and provides an initial commercialization feasibility report.

  • NDA · MTA signed
  • Technical feasibility report
  • Draft commercial terms
Expected timeline
4–6 weeks
02·

XLab co-development

iXensor ships a pre-embedded analyzer to your site to begin remote co-development. Batch-validation images go to the cloud and the iXensor algorithm team iterates until clinical-grade accuracy is reached.

  • XLab unit deployed
  • First ML model delivered
  • Analytical performance report
Expected timeline
3–6 months
03·

Clinical validation / filing

Move into formal clinical-trial design and execution. iXensor provides the technical file, quality-management documents and regulator-communication support to complete an FDA 510(k), CE-IVD or TFDA submission.

  • Trial protocol & execution
  • Technical file (STED / IFU)
  • Filing & audit response
Expected timeline
9–18 months
04·

Manufacturing & commercialization

After regulatory approval, move into production and launch prep — hardware manufacturing, app release, cloud deployment, marketing assets and channel support. iXensor provides ongoing algorithm maintenance and cloud hosting.

  • Production · ISO 13485 plant
  • App launch · cloud SLA
  • Long-term maintenance contract
Ongoing
Post-launch
05 / Compare Build vs. Partner

Build it yourself,
or build on ours?

Building a smart diagnostic product is a long road — hardware, software, regulatory, data; each step takes years. CDMO isn't about saving money — it's about buying time.

DIY

Build from scratch

  • Recruit & train an algorithm team 2+ yrs
  • Hardware prototyping & production validation 18 mo
  • Cloud architecture & security compliance 12 mo
  • Build regulatory-filing experience slow first time
  • Stand up an ISO 13485 QMS 6–12 mo
  • Build a patent portfolio from zero
  • Total time to market 4–6 yrs
With PixoTech®

Accelerate on the platform

  • Algorithms ready on day one Now
  • Three hardware forms to choose Now
  • Cloud platform delivered with SLA Now
  • 510(k) / CE / TFDA experience Proven
  • ISO 13485-certified plant available Ready
  • 100+ patents to license Covered
  • Total time to market 12–24 mo
06 / Partners Trusted by

Trusted by
the best.

Leading health-industry brands and top accelerators
have chosen to work with us.

2022
Strategic Partnership · MEDICA

A world-leading platform for scaling rapid testing and diagnostics; a strategic partnership was announced at MEDICA 2022.

2022
Strategic Investment + License

A major Japanese pharmaceutical company joined via strategic investment and signed an additional technology-licensing agreement.

2020
JLABS @ Shanghai Resident

Invited by J&J Innovation into JLABS @ Shanghai, gaining global-network acceleration resources.

2020
Startup Creasphere Program

Selected for the Roche-led Plug & Play Startup Creasphere program, alongside health startups worldwide.

2019
Partner · Digital Health

Selected as a Merck Accelerator partner, gaining digital-health resources from the German pharma leader.

Listed
Public Company · Taiwan

Listed on the Taipei Exchange, with transparency and governance following listed-company standards.

ISO
Quality Management Certified

A BSI-certified ISO 13485 medical-device quality system that has passed multiple unannounced audits.

IP
US · EU · TW · JP

The PixoTech® platform's 100+ international patents span the U.S., EU, Taiwan, Japan and other major markets.

LET'S TALK

Start with
one message.

Whether you bring a strip formulation, a clinical protocol or a brand plan — our BD team is happy to spend 30 minutes understanding your idea and tell you honestly whether PixoTech® can solve your problem. No obligation, just a technical discussion.

Email the BD team General contact form
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