4DMedical's FDA Clearance Unlocks Mayo Clinic and Philips Deals
A major US regulatory milestone has translated into a Philips order and adoption at some of America's leading academic medical centres.
26 Jun 2026 · 2 min read
In short
4DMedical achieved FDA clearance for its CT:VQ lung ventilation-perfusion imaging technology, validating clinical safety and efficacy and paving the way for US commercial adoption.
The company secured a US$10 million order from Philips and deployment at leading academic medical centres including Mayo Clinic, Stanford, Cleveland Clinic, UC San Diego Health and the University of Chicago.
NorthStar Impact Funds notes continued progress securing US hospital adoption of the XV Technology platform, alongside updates reinforcing 4DMedical's pathway toward reimbursement.
4DMedical achieved FDA clearance for its CT:VQ lung ventilation-perfusion imaging technology in September 2025, then delivered a string of transformational commercial milestones including a US$10 million order from Philips and adoption by leading US academic medical centres including Mayo Clinic, Stanford and Cleveland Clinic, though the stock has since given back some of its rally.
FDA clearance opens the door to US commercialisation
ELM Responsible Investments said that in the September quarter of 2025, 4DMedical achieved a major regulatory milestone with FDA clearance for its CT:VQ ventilation-perfusion imaging technology, validating its clinical safety and efficacy in the United States and paving the way for commercial adoption, with the company reporting a series of transformational commercial milestones building on that momentum during the December quarter.
In the September quarter 2025, 4DMedical achieved a major regulatory milestone with FDA clearance for its CT:VQ ventilation-perfusion imaging technology, validating its clinical safety and efficacy in the United States and paving the way for commercial adoption.
— ELM Responsible Investments, Quarterly Report, December 2025
A Philips order and leading medical centre adoption
NorthStar Impact Funds said 4D Medical made several significant announcements, including a US$10 million order from Philips for its CT lung imaging software, adoption of its software by medical centres at the University of Miami and Cleveland Clinic, regulatory approval in Canada, and the underwriting of $30 million worth of options due to expire at the end of the month, with the company having developed proprietary, patented software.
4D Medical made several significant announcements including a US$10m order from Philips for their CT lung imaging software, the adoption of their software by the medical centres at University of Miami and Cleveland Clinic, and regulatory approval in Canada.
— NorthStar Impact Funds, Monthly Report, December 2025
Mayo Clinic deployment confirms momentum
Perennial Partners said Mayo Clinic, consistently ranked the number one hospital in the US, agreed to deploy 4DX's Lung Ventilation Analysis Software, CT:VQ, for lung ventilation and perfusion analysis, following deployment at five other leading US academic medical centres including Stanford, Cleveland Clinic, UC San Diego Health and the University of Chicago. NorthStar Impact Funds said strong share price performance was primarily driven by positive clinical and commercial updates demonstrating momentum in the US expansion, with further progress securing US hospital and healthcare system adoption of its XV Technology platform, alongside updates reinforcing its pathway toward reimbursement.
Mayo Clinic, which is consistently ranked the number one hospital in the US, has agreed to deploy 4DX's Lung Ventilation Analysis Software called CT:VQ. This follows deployment at five other leading US Academic Medical Centres including Stanford, Cleveland Clinic, UC San Diego Health, and University of Chicago.
— Perennial Partners, Monthly Report, March 2026
What fund managers say they are watching next is continued expansion of US hospital and healthcare system adoption of the XV Technology platform, progress toward reimbursement, further orders following the Philips deal, and whether the momentum from FDA clearance continues translating into commercial deployments at leading medical centres.
Questions
What FDA clearance did 4DMedical receive?
4DMedical received FDA clearance for its CT:VQ ventilation-perfusion imaging technology, validating its clinical safety and efficacy in the United States and paving the way for commercial adoption.
Which major hospitals have adopted 4DMedical's technology?
4DMedical's CT:VQ software has been deployed at Mayo Clinic, the number one ranked hospital in the US, alongside Stanford, Cleveland Clinic, UC San Diego Health, the University of Chicago, University of Miami and others.
What was 4DMedical's deal with Philips?
4DMedical secured a US$10 million order from Philips for its CT lung imaging software, part of a broader string of commercial milestones following its FDA clearance.
5 managers, 6 comments, with each manager's latest recorded position.
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