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Last updated: June 5, 2026
Back to directoryWearable monitoring platform using a chest patch and cloud dashboard for cuffless blood-pressure monitoring and other clinician-reviewed physiologic signals.
Programs that need FDA-cleared cuffless blood-pressure monitoring or supervised remote physiologic data collection with explicit calibration, reporting, and review workflows.
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Product-specific review. These product-specific signals summarize what the cited sources imply before treating Biobeat Cuffless Blood Pressure Monitoring as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match each deployment to the exact FDA-cleared device, 510(k) number, measured parameter, intended setting, adult population, calibration requirement, and non-critical-care limitation before using outputs in care workflows. |
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| Privacy | Review Biobeat's privacy policy and enterprise contract for device data, mobile app data, dashboard access, tokenization, controller versus processor roles, anonymized analytics, geolocation connectivity data, retention, support access, and cross-border transfer controls. |
| Evidence | Validate cuffless blood-pressure and physiologic-signal performance against the local patient population, calibration process, wear time, skin and motion artifacts, home connectivity, report quality, and escalation outcomes. |
| Workflow | Best governed as clinician-reviewed remote physiologic monitoring with clear onboarding, calibration, patient instructions, report review, escalation, device troubleshooting, downtime, and removal-from-monitoring criteria. |
Biobeat describes cuffless 24-hour blood pressure monitoring with a wireless, non-invasive chest patch and lists multiple FDA 510(k) numbers; FDA records list K241066 for BB-613-BPM and K222010 for Biobeat Platform-2, with Platform-2 intended for healthcare-professional spot-checking and tracking of adult patients in hospitals, clinics, long-term care, and at home, and not intended for critical-care patients.
Not for: Critical-care monitoring, emergency response without staffed escalation, uncalibrated blood-pressure interpretation, autonomous diagnosis, or replacing clinician review of generated reports.
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.