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Exploris Health – Fertigung

Develops and markets AI-based cardiology diagnostics (Cardio Explorer®) for detecting coronary artery disease from routine data.

Exploris Health Logo

Exploris Health AG

Basel (CH)New on Amplifa

2018Founded
Basel, SwitzerlandHeadquarters (AG)
Switzerland, Germany, NetherlandsCountries of use

About Exploris Health

Exploris Health AG is a Swiss digital health and diagnostics company focused on cardiology. The company develops the Cardio Explorer®, an AI-supported software diagnostic that calculates an individualized, sex-specific probability of obstructive coronary artery disease from routine clinical chemistry data – without additional tests or sampling. The algorithmic approach is based on a machine-learned CAD model peer-reviewed and published since 2014 and was validated in European cohorts such as LURIC (AUC 0.87) and Maastricht (AUC 0.88). In 2023 the product received CE marking under the IVDD and has since been commercially deployed in Switzerland, Germany and the Netherlands, among other things integrated into Dedalus ORBIS and the Swiss electronic patient record. The company is certified to ISO 13485 (BSI) and ISO/IEC 27001 and is currently undergoing the EU IVDR conformity assessment. Customers and partners include the University Hospital of Basel, Maastricht UMC+, Roche and AOK Niedersachsen.

Site
Basel, Switzerland
Processes
AI-based diagnostics (Cardio Explorer® for coronary artery disease), Integration into hospital information systems (Dedalus ORBIS), Integration into the Swiss electronic patient record (EPR), Diagnostics from routine clinical chemistry data
Materials
Machine-learned CAD algorithm, Software as a Medical Device (SaMD), System integration (Dedalus ORBIS, EPR)
Certificates
ISO 13485, ISO/IEC 27001, EQUAL CARE (gender-equitable AI), CE Marking (IVDD), EQUAL CARE, EU IVDR (conformity assessment ongoing)
Founded
2018
Industries
Medical technology / Digital Health, Cardiology, Diagnostics (IVD)
  1. 01

    ML algorithm development (CAD diagnostics)

  2. 02

    Clinical validation in European cohorts

  3. 03

    Software development & product approval (CE/IVDR)

  4. 04

    Integration into HIS/electronic patient records

  5. 05

    Commercial distribution & study support

Technology & Algorithms

ML

Machine-learned CAD algorithm

Core diagnostic algorithm for predicting obstructive coronary artery disease from routine laboratory data, published in the International Journal of Cardiology.

Software as MD

Software as a Medical Device (SaMD)

Cardio Explorer® is CE-marked diagnostic software under the IVDD with ongoing IVDR conformity assessment.

API/KIS

System integration (Dedalus ORBIS, EPR)

Native integration into hospital information systems and the Swiss electronic patient record without workflow changes.

Locations

Standort Basel

Basel

CH

Headquarters: software development, regulatory, sales

Materials
Software as Medical Device

Products & Diagnostics

Cardio Explorer®
Cardio Explorer®Software diagnostics · Cardiology
Diagnostics from routine laboratory data
Diagnostics from routine laboratory dataAI software · Hospital/Practice

Inside the production

Cardio Explorer® presentation at ESC Munich
Cardio Explorer® presentation at ESC Munich
Partnership with Post Sanela Health AG: heart health in the electronic patient
Partnership with Post Sanela Health AG: heart health in the electronic patient
DayOne Innovation Showcase, hosted by Roche in Basel
DayOne Innovation Showcase, hosted by Roche in Basel
BSI certificate ISO 13485
BSI certificate ISO 13485
ISO/IEC 27001 certificate (information security)
ISO/IEC 27001 certificate (information security)

Industries

Medical technology / Digital HealthCardiologyDiagnostics (IVD)

Additional services

AI-based diagnostics (Cardio Explorer® for coronary artery disease)Integration into hospital information systems (Dedalus ORBIS)Integration into the Swiss electronic patient record (EPR)Diagnostics from routine clinical chemistry data

Reference customers

University Hospital of BaselMaastricht UMC+DedalusRoche (partnership)AOK Niedersachsen (study)Post Sanela Health AGMedcare

Quality & Certifications

Exploris Health is certified to ISO 13485 (certified by BSI) and ISO/IEC 27001; the EQUAL CARE certification confirms gender-equitable AI. The EU IVDR conformity assessment is in progress.

EvidenceBasel
ISO 13485
ISO/IEC 27001
CE Marking (IVDD)
EQUAL CARE
EU IVDR (conformity assessment ongoing)

Company History

  1. 2014

    Publication of the foundational ML-based CAD algorithm in the International Journal of Cardiology.

  2. 2018

    Founding of Exploris Health AG in Switzerland; LURIC validation (AUC 0.87); Swiss Biolabs Award and 2nd prize in the IFAS Innovation Challenge.

  3. 2022

    Pivotal intended-use validation in the Maastricht cohort with AUC 0.88 (BMJ Open).

  4. 2023

    CE marking (IVDD) and commercial launch in Europe; independent Rb-82 PET/CT validation (EPMA Journal).

  5. 2024

    DMEA nova Award ("Using AI to improve care"); EQUAL CARE certification; start of the AOK Niedersachsen study (ISRCTN67912485).

  6. 2025

    ISO 13485 certification (BSI); Roche partnership; integration into Dedalus ORBIS and the Swiss electronic patient record (Post Sanela); recognized as a leading Swiss AI startup.

  7. 2026

    ISO/IEC 27001 certification; completion of the AOK Niedersachsen study expected; EU IVDR conformity assessment ongoing.

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