The People
Built by people who
understand the stakes
Built by people who understand the stakes
Built by people who understand the stakes.
Guardian BioMedical is led by a team of 11 engineers and guided by advisors with direct experience in FDA regulatory pathways, medical device cybersecurity, and enterprise healthcare commercialization.
Guardian BioMedical is led by a team of 11 engineers and guided by advisors with direct experience in FDA regulatory pathways, medical device cybersecurity, and enterprise healthcare commercialization.
"The body always signals risk before failure. The challenge has been measuring it early enough to act."
"The body always signals risk before failure. The challenge has been measuring it early enough to act."
"The body always signals risk before failure. The challenge has been measuring it early enough to act."
Manny Manzel founded Guardian BioMedical on the belief that modern healthcare is architected to respond to emergencies, not prevent them.
He leads product vision, system architecture, and company strategy, building PREVIO as the infrastructure layer for predictive health in high-risk environments.
Guardian BioMedical operates with a lean engineering approach supported by experienced regulatory, cybersecurity, and healthcare commercialization advisors.
Manny Manzel founded Guardian BioMedical on the belief that modern healthcare is architected to respond to emergencies, not prevent them.
He leads product vision, system architecture, and company strategy, building PREVIO as the infrastructure layer for predictive health in high-risk environments.
Guardian BioMedical operates with a lean engineering approach supported by experienced regulatory, cybersecurity, and healthcare commercialization advisors.
The Platform
Earlier insight
changes everything
Earlier insight
changes everything
A full-stack biosensor and analytics platform built for environments where failure is not an option.
A full-stack biosensor and analytics platform built for environments where failure is not an option.
01
Capture
The PREVIO patch continuously monitors cardiac, bioelectrical, thermal, and autonomic signals simultaneously, passively, with no user effort required.
Hardware
01
Capture
The PREVIO patch continuously monitors cardiac, bioelectrical, thermal, and autonomic signals simultaneously, passively, with no user effort required.
Hardware
02
Process
On-device edge computing handles initial signal analysis before transmission, preserving performance in low-connectivity and remote field environments.
Edge Computing
02
Process
On-device edge computing handles initial signal analysis before transmission, preserving performance in low-connectivity and remote field environments.
Edge Computing
03
Analyse
ML models evaluate signals against each individual's own physiological baseline, not population averages, surfacing drift that standard thresholds miss.
ML Engine
03
Analyse
ML models evaluate signals against each individual's own physiological baseline, not population averages, surfacing drift that standard thresholds miss.
ML Engine
03
Analyse
ML models evaluate signals against each individual's own physiological baseline, not population averages, surfacing drift that standard thresholds miss.
ML Engine
04
Alert
Tiered alerts are delivered to the appropriate care team or EHR workflow, from routine monitoring flags to immediate clinical
escalation.
Clinical Output
04
Alert
Tiered alerts are delivered to the appropriate care team or EHR workflow, from routine monitoring flags to immediate clinical
escalation.
Clinical Output
04
Alert
Tiered alerts are delivered to the appropriate care team or EHR workflow, from routine monitoring flags to immediate clinical
escalation.
Clinical Output
Specifications
Built for precision,
worn like skin.
Built for precision,
worn like skin
Built for precision,
Worn like skin
Engineering decisions made for clinical environments, not consumer convenience.
Engineering decisions made for clinical environments, not consumer convenience.
4+
Signal Channels
Cardiac, bioelectrical, thermal, and autonomic signals captured simultaneously from a single flexible substrate.
4+
Signal Channels
Cardiac, bioelectrical, thermal, and autonomic signals captured simultaneously from a single flexible substrate.
14 Days
Continuous Wear
Target wear duration without recharging or replacement, validated under clinical and occupational conditions.
14 Days
Continuous Wear
Target wear duration without recharging or replacement, validated under clinical and occupational conditions.
E2E
Encrypted Architecture
End-to-end encrypted transmission with HIPAA-aligned cloud storage. Privacy is a design requirement, not a compliance add-on.
E2E
Encrypted Architecture
End-to-end encrypted transmission with HIPAA-aligned cloud storage. Privacy is a design requirement, not a compliance add-on.
E2E
Encrypted Architecture
End-to-end encrypted transmission with HIPAA-aligned cloud storage. Privacy is a design requirement, not a compliance add-on.
HL7
EHR Integration
Native integration pathways to major EHR platforms. Alerts delivered directly to existing clinical workflows.
HL7
EHR Integration
Native integration pathways to major EHR platforms. Alerts delivered directly to existing clinical workflows.
HL7
EHR Integration
Native integration pathways to major EHR platforms. Alerts delivered directly to existing clinical workflows.
Individual
Baseline Modelling
Anomaly detection referenced against each person's own baseline, not population averages. Earlier, more accurate signals.
Individual
Baseline Modelling
Anomaly detection referenced against each person's own baseline, not population averages. Earlier, more accurate signals.
Individual
Baseline Modelling
Anomaly detection referenced against each person's own baseline, not population averages. Earlier, more accurate signals.
<200ms
Edge Latency Target
On-device processing ensures low latency even in remote environments where cloud connectivity is limited.
<200ms
Edge Latency Target
On-device processing ensures low latency even in remote environments where cloud connectivity is limited.
<200ms
Edge Latency Target
On-device processing ensures low latency even in remote environments where cloud connectivity is limited.
Regulatory
Designed for
institutional standards.
Designed for
institutional standards
PREVIO is a non-diagnostic predictive monitoring system with a clear, de-risked regulatory pathway, engineered for institutional deployment from day one.
FDA 510(k) Strategy
In Progress
HIPAA Compliance Architecture
Validated
Medical Device Cybersecurity
Advisory-Led
Non-Diagnostic Classification
De-Risked Pathway
Ready to Partner
Request
clinical brief
For health systems, institutional investors, and enterprise partners who need the complete picture.
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© 2026 Guardian Biomedical, Corp. All rights reserved.
© 2026 Guardian Biomedical, Corp. All rights reserved.
© 2026 Guardian Biomedical, Corp. All rights reserved.