What Extra Horizon does

Extra Horizon N.V. is a Belgian private company headquartered in Hasselt that provides a certified Medical Backend-as-a-Service (BaaS) platform for developers of regulated digital health and medical device software. The company serves digital health startups, Software as a Medical Device (SaMD) developers, in vitro diagnostics (IVD) companies, medical imaging firms, remote patient monitoring (RPM) builders, neurotechnology companies, and traditional medical device manufacturers transitioning to connected products. Its customers and partners include FibriCheck, ams AG (ams OSRAM), ABCDx, Naox Technologies, Senova, Antelope DX, Henkel Printed Electronics, HTD Health, and Amazon Web Services.

The platform is delivered as a microservice-based cloud architecture with automated load-balancing on public cloud infrastructure, providing each customer a dedicated cluster and VPC for complete data isolation with customer-selectable data residency. Modular services cover user and authentication management (OAuth 1/2, OpenID Connect, MFA), structured data and file storage, task and event-based workflow automation across Node.js, Python, Java, .NET, Ruby, and Docker runtimes, templated email and notifications, payments (Stripe, iOS App Store), and localization. Domain-specific solutions layer on top — AI/ML hosting with GPU processing, SaMD tooling, RPM, medical imaging, clinical decision support, data encryption, and data analytics with MongoDB Charts. Developers access the platform via a REST API, JavaScript SDK, CLI, and a web-based Control Center, with a free sandbox for evaluation. The platform is pre-certified to ISO 13485:2016, ISO 27001:2022, ISO 27701:2019, IEC 62304:2015, HDS, HIPAA, GDPR, EU Cloud Code of Conduct Trusted Provider, and UK Cyber Essentials, positioning Extra Horizon as a qualified critical supplier inside customers' Quality Management Systems.

Extra Horizon operates a B2B SaaS model with quote-based, tiered annual subscriptions — Research License for prototyping, Pre-market License for pre-clinical validation, and Commercial License for certified products requiring ISO 13485 and CE/FDA market access — supplemented by professional and regulatory consulting services. Distribution combines a self-serve developer sandbox, direct enterprise field sales, and a partner ecosystem of implementation, technology, and ecosystem partners, with formal AWS Partner Network co-marketing since June 2023. The company was spun off from Qompium N.V. (the home of FibriCheck) in September 2022 and is led by co-founders Lars Grieten (CEO), Bieke Van Gorp (COO), Kobe Leysen (CTO), and Jo Van der Auwera (Chief Compliance Officer).

Name

Extra Horizon

Legal name

Extra Horizon N.V.

Website

https://extrahorizon.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

11–50 employees

Short description

Extra Horizon is a Belgian Medical Backend-as-a-Service provider offering a pre-certified (ISO 13485, IEC 62304, ISO 27001) cloud platform with microservices, SDK, and CLI for developers of regulated digital health, SaMD, IVD, RPM, and medical imaging applications.

Ownership category

akta.pro rank

Product category

Medical Backend-as-a-Service (Healthcare Cloud Infrastructure)

NAICS

Computer Systems Design and Related Services (54151), Computer Systems Design and Related Services (5415)

SIC

Services-Computer Integrated Systems Design (7373)

akta.pro primary industry

API-First Backend Platforms (BaaS/mBaaS & Serverless Backends) (HDAEAKAH)

akta.pro secondary industries

Data Aggregation, Interoperability & APIs for RPM (FHIR/IoMT Gateways) (HLACAFAO), Enterprise Integration Engines & Interface Management (HL7 v2/X12/API) (HLACABAC), EHR/EMR Integration & Interoperability Middleware (HL7/FHIR) (HLALAKAD)

Keywords

• Medical backend as a service
• Healthcare cloud infrastructure
• Regulated medical software
• Medical device compliance
• Clinical data platform

Headquarters

HQ city

Hasselt

HQ country

Belgium

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Medical Backend-as-a-Service Subscription: Platform access subscriptions with different license tiers (Research, Pre-market, Commercial) depending on development stage and regulatory requirements. Pricing varies by tier and is quote-based.
2. Professional Services: Consultation services for building, launching, and regulatory compliance. Development support and expert guidance for solution architecture.
3. Regulatory Assistance Services: Expert regulatory guidance for successful market introduction including support for CE marking, FDA compliance, and other territorial certifications.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels8 records

Core offering

Extra Horizon provides a certified Medical Backend-as-a-Service (BaaS) platform that delivers pre-certified, regulation-ready cloud backend infrastructure for connected medical devices, Software as a Medical Device (SaMD), and digital health applications. The platform exposes modular microservices (user/auth, data, files, tasks, dispatchers, mail, notifications, payments, events, localization) along with development tools (JavaScript SDK, CLI, Control Center web UI, REST API) and is sold via tiered subscriptions (Research, Pre-market, Commercial).

Product overview

Extra Horizon is a Medical Backend-as-a-Service (BaaS) company offering a certified cloud platform for connected medical devices. The product portfolio is structured as a unified platform (Medical BaaS) with integrated service modules. The core platform includes development tools: Control Center (web interface), JavaScript SDK, and CLI. Platform services are delivered as modular microservices: User Service, Authentication Service (OAuth/OpenID Connect), Data Service, File Service, Task Service, Dispatcher Service, Mail Service, Template Service, Notification Service, Payments Service (Stripe/iOS), Event Service, Webhook Service, and Localization Service. Domain-specific solutions build on the platform including AI/ML Capabilities, Software as a Medical Device (SaMD), Remote Patient Monitoring, Medical Imaging, Clinical Decision Support, Data Encryption, and Data Analytics. All offerings are pre-certified to medical device standards (ISO 13485, IEC 62304) enabling faster regulatory compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Backend-as-a-Service (BaaS) Platform Certified cloud platform providing compliant backend infrastructure for connected medical devices, MedTech startups, and SaMD developers. Includes user management, authentication, data storage, workflow automation, and communication services, all pre-certified to ISO 13485 and IEC 62304.
• Sandbox Environment

Quantifiable outcome

• Reduces time-to-market from years to months or weeks
• +3 more outcomes

Named customers4 records

Segments6 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration7 records

AI capability10 records

Feature12 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Amazon Web Services (AWS)coreTechnology or Integration · 1 June 2023Extra Horizon joined the AWS Partner Network, enabling official collaboration on cloud infrastructure. Introduced OpenID Connect single sign-on functionality enabling users to access multiple applications securely with unified credentials.
• HTD HealthcoreImplementation/ SI/ Consulting Partner · 7 April 2023Strategic partnership combining Extra Horizon's backend infrastructure with HTD Health's consulting expertise. Enables faster development of compliant digital health solutions without sacrificing regulatory standards.
• Henkel Printed ElectronicsminorStrategic or Co-development Partner · 29 April 2021Extra Horizon joined Henkel's partner ecosystem to combine expertise in medical device software platforms with advanced material solutions for wearable medical devices, accelerating healthcare digitization.
• SenovaminorStrategic or Co-development Partner · 21 April 2021Partnership to connect digital lateral flow test strips to secure cloud infrastructure. Enabled fast and compliant processing of COVID-19 test results while protecting patient data through encryption.
• Antelope DXminorStrategic or Co-development Partner · 15 April 2021Three-way partnership with Antelope DX and In The Pocket to develop an innovative home testing device featuring a connected reader, test cartridges, and smartphone app for Covid-19 and flu detection.
• ams AG (ams OSRAM)coreStrategic or Co-development Partner · 2 February 2021ams AG partnered with Extra Horizon to create a medical-cloud connected spectral sensor-based solution for COVID-19 testing. Extra Horizon provided the compliant backend for processing millions of test results with ~15 minute turnaround. Partnership enabled second deployment with Senova for SARS-CoV-2 antibody digital rapid tests.
• Software Studios / Implementation PartnerscoreChannel Partner/ Reseller/ DistributorImplementation partners ensure that Medical Devices stand out in the market by delivering exceptional experiences for both patients and healthcare practitioners. Partners provide expertise in developing mobile applications, web portals, and integrations with wearables.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• AWS HealthLake: AWS HealthLake is a HIPAA-eligible service for storing, transforming, and querying health data, plus AWS's broader healthcare services (Comprehend Medical). It competes with Extra Horizon as a healthcare-focused cloud infrastructure layer, though it lacks Extra Horizon's SaMD-specific pre-certifications (IEC 62304, ISO 13485).
• Google Cloud Healthcare API: Google Cloud's Healthcare API provides FHIR/HL7-based data ingestion, de-identification, and storage for clinical and research data. It competes on the same backend-for-regulated-healthcare-data axis as Extra Horizon, but is a general-purpose platform rather than a SaMD-specialized BaaS.
• Microsoft Cloud for Healthcare: Microsoft Cloud for Healthcare bundles Azure services, FHIR APIs, Teams for care teams, and Power Platform for health data analytics. It overlaps with Extra Horizon on cloud backend and interoperability for MedTech/regulated workloads, though at a much broader enterprise scale.

Direct peers

• Particle (Particle.io): Particle is an IoT BaaS platform providing device cloud connectivity, over-the-air updates, and managed services. It is comparable to Extra Horizon as a vertical BaaS for connected devices, though without Extra Horizon's medical-device-specific certifications.
• Redox: Redox provides a healthcare API platform for EHR/clinical system integration and data exchange. It is comparable to Extra Horizon on the health-data interoperability/API layer, with overlap in serving SaMD and digital health developers needing compliant data pipelines.
• 1upHealth: 1upHealth offers a FHIR-based health data platform for patient-mediated data access, EHR connectivity, and bulk data exchange. It overlaps with Extra Horizon on regulated health-data infrastructure and APIs, though focused more on data aggregation than full medical BaaS.
• Health Gorilla: Health Gorilla is a Clinical Data Cloud providing lab, imaging, and clinical data exchange via FHIR APIs and a developer platform. Comparable to Extra Horizon as a regulated health-data backend, with strong overlap in serving digital health developers needing interoperable infrastructure.
• Backendless: Backendless is a general-purpose BaaS offering user management, database, file storage, and real-time messaging APIs. It is comparable to Extra Horizon on the BaaS platform mechanics (modular backend services, SDK, API-first), though without medical-device regulatory certifications.
• Supabase: Supabase provides an open-source BaaS with database, authentication, storage, and edge functions. Comparable to Extra Horizon as a developer-first API-driven backend platform, though general-purpose rather than medical-specialized.

Emerging players

• CodaMetrix: CodaMetrix applies AI/ML to medical coding and clinical documentation, hosted on regulated cloud infrastructure serving hospitals. It is a partial comparable on regulated AI/ML medical workloads hosted on compliant infrastructure, but focuses on specific use cases rather than being a horizontal BaaS.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/ExtraHorizon
• GitHubgithub.com/ExtraHorizon
• LinkedInlinkedin.com/company/extra-horizon

Compliance12 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Extra Horizon