Flywhee.io

Flywhee.io

Biomedical imaging data management SaaS

Overview

Flywheel Exchange provides a cloud-based biomedical research data management platform for medical imaging and related data. It ingests, curates, and manages large imaging datasets, automates pre-processing, and enables machine learning workflows across multi-site collaborations. It differentiates itself with open APIs and SDKs (Python, R, MATLAB) and a library of plug-ins called the Flywheel Gear Exchange to automate tasks like metadata extraction, quality assurance, and running full analytic pipelines, plus Radiologics helps broaden clinical-trial workflow capabilities. It runs on a subscription-based SaaS model with tiered pricing based on usage, and its goal is to speed biomedical imaging research and AI development in secure, compliant, multi-site environments.

About Flywhee.io

Simplify's Rating
Why Flywhee.io is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

AI & Machine Learning

Healthcare

Company Size

51-200

Company Stage

Growth Equity (Venture Capital)

Total Funding

$153.2M

Headquarters

Minneapolis, Minnesota

Founded

2015

Simplify Jobs

Simplify's Take

What believers are saying

  • Flywheel serves 10 of the top 20 pharma companies and 10 top medical centers.
  • January 2026 financing from Novalis LifeSciences and 8VC extends product development runway.
  • Open APIs plus Python, R, and MATLAB SDKs reduce integration friction for research teams.

What critics are saying

  • NVIDIA-style imaging stacks compress Flywheel into a commodity data layer within 18 months.
  • Large pharma teams will unbundle orchestration with internal pipelines, weakening pricing power.
  • Clinical-trial incumbents can bundle imaging workflows, blocking Flywheel's 21 CFR Part 11 expansion.

What makes Flywhee.io unique

  • Flywheel targets medical imaging data management for researchers, not generic enterprise data warehousing.
  • Flywheel Validated supports 21 CFR Part 11 clinical-trial workflows, a regulated niche.
  • Gear Exchange automates metadata extraction, QA, and pipelines through reusable plug-ins.

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Funding

Total Funding

$153.2M

Below

Industry Average

Funded Over

9 Rounds

Growth Equity VC funding comparison data is currently unavailable. We're working to provide this information soon!
Growth Equity VC Funding Comparison
Coming Soon

Benefits

Health Insurance

Paid Vacation

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

-2%

2 year growth

-1%
Listcorp
Apr 19th, 2026
GSK contract, UK clearance for CTVQ, and ASX 200 inclusion.

GSK contract, UK clearance for CTVQ, and ASX 200 inclusion. 5.93 +0.09 (+1.54%) ASX announcement ASX: 4DX The future of lung health Melbourne Level 7 Melbourne Connect 700 Swanston St reet Carlton V IC 30 53 Los Angeles 21255 Burbank Boulevard Suite 1 20 Woodland Hills CA 91367 4DMedical L imi t e d ABN: 31 161 684 831 Email: [email protected] 1 Tel: +61 (3) 9545 5940 Tel: +1 (818) 403 - 8490 www.4 DM edical.com GSK contract, UK clearance for CT:VQ (TM), and ASX 200 inclusion 20 April 20 26 Highlights - Contract executed with GlaxoSmithKline (GSK), one of the world's largest pharmaceutical companies, to supply 4DMedical's functional lung imaging analytics in support of pulmonary drug development - CT:VQ (TM) receives UKCA certification for clinical use in the United Kingdom, expanding 4DMedical's European footprint following CE Mark certification in March 2026 - UK clearance opens access to one of the world's most developed diagnostic imaging markets, with millions of chest CT scans performed annually across respiratory, oncology and acute care pathways - Coronary Artery Calcium (CAC) analysis cleared in Canada, coinciding with 4DMedical's participation at the Canadian Association of Radiologists (CAR) Annual Scientific Meeting in Montreal - CMS establishes a new US reimbursement pathway for AI - based opportunistic coronary calcium analysis from routine chest CT scans, enabling scalable clinical and commercial adoption - 4DMedical included in the S&P/ASX 200 Index, effective prior to the open of trading today Melbourne, Australia, 20 April 20 26 - 4DMedical Limited (ASX: 4DX, "4DMedical" or the "Company"), a global leader in respiratory imaging technology, today announce s a series of commercial, regulatory and corporate milestones that further expand global market access and validate demand for its advanced cardiopulmonary imaging analytics platform. Strategic pharmaceutical engagement with GSK 4DMedical has entered a contractual engagement with GlaxoSmithKline (GSK), in association with leading imaging data platform Flywheel Exchange, to provide its proprietary quantitative lung imaging analytics in support of pulmonary drug development and clin ical research. Under the one - year agreement, 4DMedical will supply advanced lung imaging biomarkers from its software analytics platform, enabling sensitive, quantitative assessment of lung structure and function across clinical trial cohorts. The contract commences on 1 May 2026. The contract value is commercially confidential and is not individually material. The engagement with one of the world's largest pharmaceutical companies reflects increasing adoption of 4DMedical's analytics platform by global biopharmaceutical companies seeking scalable, reproducible imaging endpoints to improve trial efficiency, patie nt stratification, and longitudinal disease assessment. The GSK contract builds on 4DMedical's established pharmaceutical relationships, including its ongoing engagement with AstraZeneca, and reinforces the Company's position as a preferred provider of qua ntitative imaging analytics for respiratory drug development. UK clearance for CT:VQ (TM) expands European footprint CT:VQ (TM) continues to be 4DMedical's primary commercial growth driver in the United States, where FDA clearance has enabled deployment across leading Academic Medical Centers (AMCs) and positioned the technology at the forefront of next - generation functional lung imaging. CT:VQ (TM) is now deployed at six leading U.S. AMCs, with additional institutions actively evaluating the technology. (C) 4DMedical Limited 2 4DMedical.com The Company is pleased to advise that, following the receipt of CE Mark certification in March 2026, CT:VQ (TM) has now obtained UKCA certification for clinical use in the United Kingdom, under the regulatory oversight of the Medicines and Healthcare products Regulatory Agency (MHRA). This regulatory clearance allows for the immediate commercial deployment of CT:VQ (TM) across both public and private healthcare providers within the UK. The UK represents one of the world's most developed diagnostic imaging environments. Millions of chest CT scans are performed annually, with CT forming a core diagnostic tool for lung cancer screening, COPD, interstitial lung disease, pulmonary embolism, a nd acute care workflows. CT:VQ (TM) is uniquely positioned to integrate into these established pathways by delivering quantitative ventilation and perfusion insights from routine non - contrast CT scans, without the complexity or constraints of nuclear medicine. Europe and the UK play a critical role in shaping global respiratory medicine and imaging practice. Institutions such as the Royal Brompton Hospital in London, where 4DMedical clinical research is underway, are internationally recognised centres of excellence in cardiopulmonary research and clinical care, with strong collaborative ties to North American AMCs. UK clearance enables 4DMedical to engage directly with leading European and UK clinicians, support investigator - initiated research, and contribute to the global clinical evidence base underpinning CT:VQ (TM). This engagement is complementary to the Company's US commercial strategy and reinforces the long - term clinical credibility of its platform. With UKCA and CE Mark certifications now in hand, 4DMedical holds regulatory clearance for CT:VQ (TM) across the United States, the European Union, the United Kingdom, Canada, and New Zealand. CAC clearance in Canada The Company confirms that its Coronary Artery Calcium (CAC) analysis solution has received regulatory clearance from Health Canada, permitting clinical use across Canadian healthcare institutions. This milestone coincides with 4DMedical's attendance at the Canadian Association of Radiologists (CAR) Annual Scientific Meeting in Montreal over the weekend, where the Company presented its expanding cardiopulmonary imaging portfolio to radiologists, researchers and health system leaders. 1 1 1 REGULATORY COMPLIANCE - REGULATORY STATUS FDA (USA) CE Mark (EU) TGA (AU) CMDR (Canada) MHRA (UK) Medsafe (NZ) ANVISA (Brazil) CAC ü ü Under review ü CT LVAS ü ü ü ü ü CT:VQ ü ü Under review ü ü ü IQ - UIP ü Under review LDA ü ü ü ü ü ü LTA ü ü ü ü ü PHA ü * RV/LV ü ü ü ü XV LVAS ü ü ü 4DMedical Limited (ASX:4DX) is a medical technology company aiming to deliver the global gold standard in respiratory diagnostics for all... 4DX Profile Links 4DX Information Share Price: 24hr Change: 24hr Change %: Market Cap: Join Listcorp to create a personalised news feed, follow your favourite companies, save useful news, and more. 13 Apr 2026 10 Apr 2026 27 Mar 2026

Flywheel
Jan 8th, 2026
Flywheel reports record growth, launches products to support clinical trial and medical device markets, and closes $27.5M equity round

Flywheel reports record growth, launches products to support clinical trial and medical device markets, and closes $27.5M equity round. Minneapolis, MN - January 8, 2026 - Flywheel, the leading medical imaging data management and analysis platform, today announced key milestones achieved in 2025. The company also recently closed on an oversubscribed $25 million financing round, led by Novalis Lifesciences and 8VC. Flywheel has evolved from its origin as a technology platform designed to support core lab research to an enterprise imaging management platform designed to support clinical trials, medical device development and AI innovation through at-scale data aggregation, curation and analysis. Over the past year, Flywheel expanded its core capabilities by launching video viewing and annotation tools, along with Flywheel Validated, a solution that streamlines 21 CFR Part 11 compliant workflows for clinical trials. Together, these capabilities are designed to enable earlier access to imaging data with provenance, reduced costs and improved quality - ultimately helping accelerate time to decision and time to market. "Imaging data holds tremendous value and is increasingly viewed as a strategic asset. Unlocking this value requires more than just a foundational infrastructure to aggregate data. It involves integrated data management, curation, compliant workflows and AI capabilities, along with access to a connected healthcare ecosystem - all at scale. Flywheel is well-positioned to uniquely transform how companies can maximize value from their imaging assets by better informing clinical trials, accelerating AI development and enabling research and clinical teams to move faster from discovery to decision," said Hooman Hakami, Flywheel CEO and Board Chair. Customer base: 10 of the top 20 global pharmaceutical companies have selected Flywheel to advance digital transformation strategies and accelerate the development and use of imaging endpoints and AI-ready datasets. Flywheel also serves 10 of the top 20 academic medical centers (AMCs) and expanded its product capabilities to better serve medical device companies, research sponsors and their partner sites. Platform adoption: Flywheel achieved 43% year-over-year growth in new business, leading to a 40% increase in committed revenue. Annual recurring revenue (ARR) from pharmaceutical and medical device customers grew 106% versus the prior year. The company's overall net revenue retention exceeded 110%, reflecting strong customer loyalty and expanding adoption across key markets. New products: During 2025, Flywheel launched its video viewing and annotation tool to enable management and analysis of video data alongside imaging data. In December, the company launched Flywheel Validated to help clinical trial stakeholders better access and analyze their clinical trial imaging data to facilitate faster decision-making and secondary data use within a 21 CFR Part 11 compliant environment. Capital investment: In December, the company raised $27.5 million in equity financing. This new capital will further accelerate product innovation and support the company's continued growth, particularly in the area of image management for clinical trials and AI model development. To learn more about the Flywheel platform or to request a demo, please visit www.flywheel.io. About Flywheel With its leading medical imaging platform, Flywheel, Inc serve the overall healthcare market. With its offerings, Flywheel, Inc drive innovation in three distinct customer segments: 1) Biopharmaceutical companies, 2) Medical Device manufacturers, and 3) Academic Medical Centers. Its solutions allow its customers to realize optimum value from their imaging data assets by streamlining imaging data management, automating research workflows and preparing data for AI development. The company is backed by investors including Novalis LifeSciences LLC, 8VC, NVIDIA, Microsoft, Novartis and Intuitive Surgical, among others. For more information on its mission and products, visit www.flywheel.io or follow Flywheel, Inc on LinkedIn.

Newswise
Dec 2nd, 2025
Flywheel Launches Validated Imaging Solution to Accelerate Decision-Making Across the Clinical Trial Ecosystem

Flywheel launches validated imaging solution to accelerate decision-making across the clinical trial ecosystem. 2-Dec-2025 10:05 AM EST, by Flywheel Newswise - MINNEAPOLIS, Dec. 2, 2025 /PRNewswire/ - Flywheel, the leading medical imaging data management and analysis platform, today announced the launch of Flywheel Validated, a solution designed to streamline compliant imaging workflows and improve data access for clinical trial stakeholders. Flywheel Validated (a specific version of Flywheel's core technology platform) is compliant with 21 CFR Part 11, helping organizations conducting regulated or near-regulated trials and AI model development accelerate time-to-decision and time-to-market. The goal is to empower life sciences organizations and researchers by providing a faster pathway to their imaging data - ultimately leading to clearer decisions and higher confidence throughout the trial or project lifecycle. Flywheel Validated unlocks a critical bottleneck in clinical research by helping pharmaceutical sponsors, reading centers, CROs, and academic medical centers access and analyze their clinical trial imaging data earlier and more efficiently - while being designed to maintain regulatory compliance and trial integrity. This purpose-built solution expands on the existing Flywheel Research platform that accelerates imaging data aggregation, curation, and analysis via automated processing pipelines. It provides a guided data upload experience for site contributors in multicenter studies and supports human-in-the-loop workflows, including validated imaging reads and quality control. The Flywheel Validated offering also includes audit trail, project locking, and e-signature capabilities, ensuring users can confidently leverage auditable results for regulatory submission. "Our Flywheel Validated solution addresses long-standing barriers in clinical trials: the slow, fragmented access to high-quality, compliant data," said Shelby Wyatt, Chief Product Officer at Flywheel. "With Flywheel Validated, Pharma sponsors can glean insights and adjust trials from imaging data earlier, while reading centers streamline their operations from guided uploads, automated checks, and structured validated reads in a unified platform. In doing so, we're enabling organizations across the entire clinical trial ecosystem unlock clearer, earlier findings - helping to avoid wasted time and money and ultimately improving trial outcomes." Flywheel will showcase the Flywheel Validated solution in the upcoming GEN webinar on December 11, 2025, titled "Accelerating Clinical Decisions Through Faster Access to Imaging Data." For more information or to request a demo, visit flywheel.io. About Flywheel Flywheel offers the leading medical imaging platform that empowers healthcare innovation by streamlining imaging data management, automating research workflows and preparing data for AI development. Flywheel's comprehensive solution is designed to allow pharmaceutical and biotechnology companies, academic medical centers, AI developers and medical device manufacturers to realize optimum value out of their imaging data assets. For more information on our mission and products, visit www.flywheel.io or follow us on LinkedIn. Media contact.

Flywheel
Apr 10th, 2025
Flywheel Releases Enhanced Multimodal Functionality with Video Capabilities to Expand Research Innovation for Life Sciences

Flywheel, the leading medical imaging data management and analysis platform, announced the launch of a video viewing and annotation tool to manage and analyze video alongside imaging and associated data within its platform.

The Business Journals
Jan 14th, 2025
Startup Flywheel raises $20 million for managing medical image data

A Minneapolis-based med-tech software firm that's been backed by Nvidia Corp., Novalis Lifesciences and Microsoft recently raised $20 million.

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