Vasowatch Inc is redefining maternal health with a first-in-class, non-invasive digital biomarker that predicts postpartum hemorrhage (PPH) before delivery. Using heart rate wearables and a proprietary algorithm, Vasowatch identifies myometrial fatigue — the leading cause of hemorrhage — in real time. By giving clinicians hours of advance warning, the platform enables faster, more effective care, improving outcomes and addressing racial disparities in maternal mortality.
Lead Program & Pipeline
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Lead product: Vasowatch System, a SaMD (Software as a Medical Device) Class II De Novo
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Predicts PPH by detecting myometrial fatigue from streaming maternal heart rate
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Continuously updates hemorrhage risk status during labor via wearable sensors
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Clinical pilot (300 patients) underway to validate system accuracy, usability, and impact
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14 Letters of Intent to pilot from U.S. health systems totaling 70,000+ births/year
Technology Differentiators
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First tool to predict PPH physiologically — not by historic or demographic risk
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Uses FDA-cleared wearables + proprietary algorithm for non-invasive monitoring
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Provides hours of advance notice before delivery, enabling timely interventions
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Targets a $2B global market with subscription-based reimbursement model
Stage & Investment
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Stage: Preparing for pivotal trial; pre-revenue
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Funding Raised: <$500K
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IP: Licensed patent + provisional patent from Vanderbilt; includes software copyrights
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Regulatory Pathway:
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SaMD Class II De Novo
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FDA pre-submission meeting completed; Breakthrough Device Designation applied
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Targeting De Novo submission by 2026; FDA approval forecast for 2027
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Collaborators: Vanderbilt, University of Pennsylvania, ChristianaCare, GE Healthcare, Philips, Organon
What's Next
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Execute 300-patient clinical pilot (est. 12 months)
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Submit second pre-submission meeting request to FDA
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Finalize pivotal trial design and verification/validation testing
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Secure strategic distribution partnerships and prepare for commercialization