Flywheel.io

What Flywheel.io does

Flywheel.io is a Minneapolis-headquartered, venture-backed medical imaging data management and AI development platform operating as Flywheel Exchange, LLC. Founded in 2015 from technology originally developed at Stanford by Dr. Brian Wandell and Gunnar Schaefer in partnership with Invenshure, the company sells cloud-native, modular software that automates the curation, annotation, computation, and governance of biomedical imaging data — covering MRI, CT, PET, EEG, digital pathology, ophthalmology imaging, and video — for pharmaceutical and biotech companies (10 of the top 20 global), academic medical centers (10 of the top 20), medical device manufacturers, CROs, and AI developers.

The core platform, Flywheel Core, is a SaaS data management system available as a multi-tenant environment on Microsoft Azure and as private deployment across major clouds. It is differentiated by deep regulatory infrastructure (21 CFR Part 11 validation via Flywheel Validated, HIPAA, GDPR, GCP, SOC 2 Type II, SOC 3), an extensible Gear Exchange of more than 70 containerized plug-in algorithms, open REST APIs and SDKs for Python, MATLAB, and R, and integrations with NVIDIA MONAI, AWS HealthImaging, Azure Machine Learning, Mint Medical, and CVAT. Adjacent modules — Reader Studies for blinded annotation workflows, Discovery for cohort search, and vertical solutions for neuroscience, oncology, and ophthalmology research — extend the platform from a data lake into an end-to-end clinical trial and AI development system.

Flywheel generates revenue primarily through enterprise SaaS subscriptions with annual billing, augmented by a Flywheel Validated compliance add-on and a Scientific Solutions Engineers professional services line for custom pipeline and integration work. Pricing is quote-based and not publicly disclosed. The company sells through direct enterprise field sales to pharma and medical device buyers, co-sell arrangements with cloud and AI partners (AWS, NVIDIA, Microsoft), and cloud marketplaces, and reports 106% ARR growth in pharma and medical device customers, 43% year-over-year new-business growth, and over 110% net revenue retention in 2025. It has raised approximately $123M+ in equity across a 2021 Series C ($22M), a 2023 Series D ($54M led by Novalis LifeSciences and NVentures), and 2025-2026 rounds totaling roughly $45-47.5M led by Novalis LifeSciences and 8VC, with strategic investors including NVIDIA, Microsoft, Novartis, and Intuitive Surgical.

Name

Flywheel.io

Legal name

Flywheel Exchange, LLC

Website

https://flywheel.io

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

101–250 employees

Short description

Flywheel.io is a cloud-based medical imaging data management and AI development platform that helps pharmaceutical companies, academic medical centers, and medical device manufacturers curate, annotate, compute on, and govern imaging data at enterprise scale with regulatory-grade compliance.

Ownership category

akta.pro rank

Product category

Medical Imaging Data Management Software

NAICS

Software Publishers (5132), Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services (51821)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Regulatory Information Management (RIM) & Submission Publishing Software (HLAGAJAL)

akta.pro secondary industry

Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB)

Keywords

• Medical imaging platform
• Clinical trial imaging
• Biomedical data management
• Imaging AI workflows
• Research data curation

Headquarters

HQ city

Minneapolis

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Software Subscription (SaaS): Cloud-based software-as-a-service platform with subscription pricing for medical imaging data management. Flywheel Core is available as multi-tenant environment on Microsoft Azure and as private deployment across major cloud providers.
2. Professional Services: Scientific Solutions Engineers providing consulting, training, and technical support. Services include development of Gears and Pipelines, data ingestion, BIDS, RedCap, HPC integration, reader studies, and custom SDK implementation.
3. Flywheel Validated (Compliance Add-on): Validated 21 CFR Part 11 compliant version of the platform with enhanced compliance features including managed audit services, biannual support hours with customer-hired auditor, and documentation support.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels8 records

Core offering

Flywheel sells a cloud-native SaaS platform for medical imaging data management and AI development that ingests, curates, computes on, and governs imaging datasets for pharmaceutical, biotech, medical device, CRO, and academic medical center customers. The platform centers on Flywheel Core and adds specialized modules including Flywheel Validated (21 CFR Part 11 compliance), Flywheel Discovery (cohort search), Flywheel Gear Exchange (containerized plug-in algorithms), and a Reader Studies Module for annotation at scale, supported by professional services and SDKs for Python, MATLAB, and R.

Product overview

Flywheel is a comprehensive medical imaging data management and AI development platform comprising a unified core product (Flywheel Core) plus specialized modules and add-ons. The platform architecture includes Flywheel Core for foundational data management and AI workflows, Flywheel Validated for 21 CFR Part 11 clinical trial compliance, Flywheel Discovery for cohort search and identification, Flywheel Exchange for curated external datasets, the Reader Studies Module for annotation workflows, and the Gear Exchange for plug-in algorithms. Additional specialized solutions address therapeutic areas including neuroimaging, oncology, and ophthalmology. Professional services (Scientific Solutions Engineers) and SDKs (Python, MATLAB, R) extend the platform for custom development. The platform is deployed on major cloud providers and supports integrations with NVIDIA MONAI, AWS HealthImaging, Mint Medical, CVAT, RedCap, and Microsoft Azure Machine Learning.

Differentiator

Problem solved

Functional benefit

Brands

• Flywheel Core: Software-as-a-service solution for advancing medical imaging AI at scale.
• Flywheel Validated
• Flywheel Gears
• Flywheel Validated Core
• Flywheel Reader Studies Module

Products and services

• Flywheel Core Flagship cloud-native SaaS platform for medical imaging data management that ingests, curates, computes on, and governs imaging and video data at enterprise scale. It is the foundation for all Flywheel modules and is targeted at pharmaceutical, biotech, medical device, CRO, and academic medical center buyers.
• Flywheel Validated 21 CFR Part 11-compliant add-on to Flywheel Core for regulated clinical trial imaging, featuring audit trails, project locking, e-signatures, time-stamped audit trails, and a guided case uploader for multicenter studies, imaging reads, and quality control.
• Flywheel Discovery Enterprise-scale analysis add-on that enables comprehensive search across imaging and video data to identify and ingest files from multiple sources, find subjects, and build cohorts for downstream research and AI workflows.
• Flywheel Exchange (Datasets) Provides access to pre-curated, ready-to-use imaging datasets from publicly available sources and provider networks, complementing Flywheel Core for end-to-end research and AI workflows.
• Flywheel Gear Exchange Library of containerized plug-in algorithms (Gears) with mandatory versioning and image persistence that automate metadata extraction, classification, quality assurance, format conversion, BIDS conversion, and full analytic pipelines within Flywheel Core.
• Reader Studies Module Module for managing image quality reviews and annotation workflows at scale, including task assignment, adjudication dashboards, custom reader forms, automated data tagging, and comparison outputs from multiple readers for blind reader studies.
• Scientific Solutions Engineers (Professional Services) Consulting, training, and technical support offering that builds custom Gears and Pipelines, performs data ingestion, BIDS curation, RedCap and HPC integration, reader study setup, and custom SDK implementations for enterprise customers.
• Ophthalmology Solutions Specialized capabilities for ophthalmology research including support for retinal imaging modalities (OCT, fundus photography, fluorescein angiography), automated OCT QA, and annotation tools such as the interactive ETDRS grid and retinal layer segmentation.
• Oncology Solutions Specialized capabilities for oncology imaging research including tumor segmentation, blinded reader workflows, multimodal data support, and integration with Mint Medical's mint Lesion software for structured tumor analysis.
• Neuroimaging Solutions Specialized capabilities for neuroimaging research including BIDS conversion and curation, BIDS Apps (MRIQC, fMRIPrep), support for MRI, CT, PET, EEG modalities, and easy conversion of DICOM to NIfTI.

Quantifiable outcome

• Up to 90% cost reduction in annotation campaigns
• +7 more outcomes

Named customers20 records

Segments5 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 capability8 records

Feature9 records

Partnerships

Six partnerships are on record, tiered core and minor.

• AWS HealthImagingcoreTechnology or Integration · 19 May 2026Integration with AWS HealthImaging enables biopharma, medical device, and academic medical centers to transform imaging and video data into an enriched, reusable Enterprise Golden Data Lake. Flywheel serves as the governed activation layer while AWS HealthImaging provides optimized DICOM data storage, supporting regulated clinical workflows including imaging-based endpoint analysis and AI-ready cohort development.
• Mint MedicalcoreStrategic or Co-development Partner · 8 July 2024Collaboration provides academic medical centers, cancer research institutes, oncology consortiums, and pharmaceutical companies with streamlined integration between platforms. Flywheel's data management combined with Mint Medical's mint Lesion software enables efficient oncology image analysis, tumor detection, and treatment planning.
• VelseraminorStrategic or Co-development Partner · 4 April 2024Collaboration supports multimodal imaging genomics research, combining Flywheel's imaging platform capabilities with Velsera's genomics expertise.
• NVIDIAcoreTechnology or Integration · 22 November 2023NVIDIA MONAI accelerated AI workflows for AI-assisted annotation and scalable training integrated with Microsoft Azure Machine Learning. Flywheel users can rapidly build AI models using embedded Jupyter Notebooks with NVIDIA GPU acceleration.
• Microsoft AzurecoreTechnology or Integration · 22 November 2023Flywheel Core is available as multi-tenant SaaS environment on Microsoft Azure, with integration into Azure Machine Learning for AI model development. Microsoft is also a financial backer of the company.
• Siemens HealthineerscoreStrategic or Co-development Partner · 17 July 2021Flywheel delivers cloud-based research collaboration solution for Siemens Healthineers and research partners worldwide to securely share data and algorithms, driving innovation in medical imaging.

Scale indicators18 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Velsera: Scientific informatics platform serving pharma, biotech, and clinical research with multi-omics data management, including imaging genomics. Directly comparable to Flywheel in customer base, regulated workflow support, and multimodal scientific data management.
• Arterys (Tempus): Cloud-native medical imaging AI platform with FDA-cleared algorithms for cardiology, oncology, and lung, acquired by Tempus. Comparable to Flywheel in cloud-native medical imaging, AI workflow support, and clinical-grade compliance positioning.
• Quibim: Imaging biomarker and AI platform for pharma and clinical research, focused on oncology, neuroscience, and metabolic disease. Closely comparable to Flywheel in serving pharma trials, building AI-ready datasets, and operating in regulated imaging endpoints.
• MIM Software: Medical imaging analysis software with strong oncology and radiotherapy footprint and pharma trial imaging services. Comparable in clinical imaging workflow, oncology focus, and pharma trial endpoint support.
• RadLogics: AI-powered medical imaging analysis platform deployed for radiology workflow and clinical trial imaging. Comparable to Flywheel in clinical imaging AI and pharma/clinical research use cases.

Emerging players

• Rhino Health: Federated learning and medical imaging data platform for AI development across hospitals. Comparable to Flywheel in enabling multi-site medical AI workflows, though more focused on federated compute than full data curation.

Broad incumbents

• Tempus Labs: Large precision medicine data platform combining clinical, molecular, and imaging data for AI development in oncology. Comparable in serving pharma AI development, though broader in scope (multi-omics plus imaging).
• Siemens Healthineers: Global medical imaging and diagnostics incumbent with broad enterprise imaging IT, AI, and clinical research offerings. Comparable as a partner/incumbent in the medical imaging data management space, with much broader portfolio scope.
• Philips (HealthSuite / Intellispace): Healthcare technology incumbent with enterprise imaging informatics (Intellispace) and clinical research offerings. Comparable in addressing enterprise imaging data workflows but with much broader focus beyond life science R&D.

Others

• NVIDIA (Clara / MONAI): Strategic technology partner providing GPU acceleration and the MONAI framework that Flywheel integrates with. Adjacent/ecosystem participant — not a direct competitor, but a key enabler of medical imaging AI that could potentially extend into adjacent platform layers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/flywheel_io
• YouTubeyoutube.com/channel/UCFUZJp3LrLzS10uiUKNZJqg
• LinkedInlinkedin.com/company/flywheel-io
• Facebookfacebook.com/Flywheelio-409224686545192

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds8 records

Investors22 records

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

M&A1 record

Investments

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

Frequently asked questions about Flywheel.io