Biovitals Analytics Engine

by Biofourmis Singapore Pte.  · Based in United States → — AI-powered health analytics for personalized, predictive care.
Cardiology Critical Care Pulmonology

Contact for pricing
Regulatory Status Disclosed

Overview

The Biovitals™ Analytics Engine, developed by Biofourmis, is a sophisticated AI and machine learning-powered health analytics platform. It is designed to integrate and analyze continuous physiological data from FDA-cleared wearable biosensors and other medical-grade clinical devices in near real-time. The engine identifies correlations between multiple vital signs and a patient’s daily activities, building an individualized biometric signature that dynamically updates. By computing a time-series Biovitals™ Index, the platform alerts providers to changes in a patient’s measured vital signs from their baseline, which can be a precursor to clinical exacerbation days or even weeks before a critical event. This capability enables earlier clinical intervention, aiming to reduce hospital readmissions and emergency department visits. The Biovitals™ Analytics Engine serves as the foundation for Biofourmis’ digital therapeutics product pipeline across various therapeutic areas and supports applications in ambulatory healthcare settings, at home, and for pharmaceutical research and medical device development.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI and Machine Learning-powered analytics
  • Processes multiple physiological signals (heart rate, respiratory rate, activity, temperature, blood oxygenation, heart rate variability, inter-beat-interval)
  • Generates a time-series Biovitalsu2122 Index to alert providers to changes from baseline
  • Predicts clinical exacerbation in advance of critical events
  • Continuous, near real-time monitoring
  • Compatible with FDA-cleared wearable biosensors and medical-grade clinical devices
  • Cloud-based software engine
  • Web dashboard for clinician review and notifications
  • Patient-facing companion mobile app for data tracking and communication
  • Secure API for data input and output

Use Cases

  • Reducing hospital readmissions and emergency department visits
  • Remote monitoring of patients with complex chronic conditions (e.g., heart failure, COPD, atrial fibrillation)
  • Enabling early clinical intervention for patient deterioration
  • Supporting 'Hospital at Home' and other virtual care programs
  • Generating real-world evidence for pharmaceutical research and medical device development
  • Medication optimization and adherence support

What Physicians Need to Know

Key Capabilities
AI and machine learning-powered analytics engine that processes physiologic data (heart rate, respiratory rate, activity) from FDA-cleared sensors in near real-time. It builds individualized biometric signatures by identifying correlations between vital signs and daily activities, computing a Biovitals Index to predict patient decompensation weeks in advance.
Clinical Utility
Enables earlier clinical intervention, potentially reducing hospital readmissions and emergency department visits. It supports efficient monitoring for complex chronic conditions like heart failure, COPD, and atrial fibrillation, and provides a foundation for digital therapeutics across various therapeutic areas.
Integration Options
Cloud-based software engine designed to integrate with FDA-cleared biosensors and existing cardiac monitoring solutions via API. It operates through cellular connection and is part of a comprehensive Care-at-Home solution that includes clinician and patient-facing technology.
Compliance Status
Received 510(k) clearance from the U.S. FDA as a medical device for ambulatory physiological monitoring in October 2019, recognizing its machine-learning and AI capabilities in the Software as a Medical Device (SaMD) category. The software is classified as a 'moderate level of concern' and complies with recognized consensus standards.
User Experience
Continuously personalizes the user experience to optimize engagement. Clinicians review the Biovitals Index via a dashboard, displayed in 30-minute segments. Patient-facing mobile apps are also part of the broader Biovitals ecosystem.
Support Quality
Biofourmis' Care-at-Home solution offers comprehensive support, including operational services, logistics, technical support, and access to a multidisciplinary care team with registered nurses and physicians for around-the-clock monitoring.
Implementation Complexity
Designed as a modular build, allowing for easy adaptation and customization across various disease states. It facilitates quick deployment of necessary workflows and technologies for hospital-level care at home.
Evidence Base
FDA clearance was based on clinical studies monitoring patients with complex chronic conditions in real-world, at-home settings. Studies demonstrated predictions of heart failure decompensation 12 days in advance and improved medication adherence. It is also used in research partnerships with institutions like Yale University-Mayo Clinic CERSI and Brigham and Women's Hospital.
Physician Tip

Leverage the Biovitals Analytics Engine for proactive patient management, especially for those with chronic conditions requiring continuous monitoring. The predictive analytics can provide early warnings of decompensation, allowing for timely interventions and potentially preventing hospitalizations. Integrate the Biovitals Index into your daily patient review workflows for a quick, personalized snapshot of patient health trends. Consider its utility in value-based care models to improve outcomes and reduce costs.

The Biovitals Analytics Engine is designed to be cloud-based and can integrate with various FDA-cleared wearable biosensors and existing clinical systems through APIs. This modularity allows for flexible deployment and customization to fit diverse healthcare IT infrastructures and patient monitoring needs. Ensure compatibility with your current sensor ecosystem and EHR for seamless data flow and clinician access.

Details

Category Triage & ER/ICU AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Biovitals™ Analytics Engine received FDA 510(k) clearance (K183282) on August 15, 2019, for ambulatory physiological monitoring. It processes continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity, leveraging AI and machine learning to identify changes from a patient's individualized baseline.

Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Pulmonology

What the Web Says

The Biofourmis Biovitals Analytics Engine is an AI-powered platform designed for remote patient monitoring and predictive analytics in healthcare. It leverages machine learning and proprietary AI to continuously analyze data from medical-grade wearable sensors and other patient-generated data, creating digital biomarkers to reflect an individual's health status. The platform aims to reduce hospital readmissions, limit emergency room visits, and improve patient outcomes by providing early alerts to clinicians about changes in a patient's condition.

Overall: Positive

Strengths

  • Real-time AI analysis improves preventative care and enables earlier clinical intervention.
  • Reduces hospital readmissions and emergency department visits.
  • Provides personalized medicine with granular insights and optimizes drug dosages.
  • Leverages robust physiology and bio-psychological analytics to identify deviating factors and generate personalized insights.
  • FDA cleared as a medical device for ambulatory physiological monitoring.
  • Supports various applications across healthcare, including chronic condition management (e.g., heart failure, COPD, atrial fibrillation).

Limitations

  • High initial investment costs for infrastructure and AI model training.
  • Potential for algorithmic bias in AI models, which could disproportionately affect vulnerable populations.
  • Reliance on the system may lead to over-diagnosis and unnecessary interventions.
  • Data privacy concerns remain despite advanced encryption protocols.
  • Potential for job displacement among traditional medical professionals.
  • Pricing is not publicly published, requiring direct vendor contact for a custom quote.

Based on reviews from: The Silicon Review, ITQlick, HIT Consultant, Medical Device Network, NS Medical Devices, BioSpace

Last updated: 2026-07-18

Ratings & Reviews

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Press & Coverage

Unite.AI
Transforming Telehealth: How AI-Powered Virtual Consultations and Remote Monitoring Are Shaping the Future of Healthcare
This article from April 2024 highlights how Biofourmis' Biovitals Analytics Engine processes physiological data to predict events like heart failure decompensation days in advance, enabling early intervention and potentially preventing hospital admissions. It emphasizes the role of AI in enhancing healthcare delivery through real-time biomarker monitoring and personalized biometric signatures.
2024-04
MassDevice
Biofourmis and Chugai Pharma partner to develop an objective measure of pain
In March 2023, Biofourmis and Chugai Pharma announced their continued collaboration to develop digital technologies, based on Biofourmis' Biovitals analytics engine, to objectively measure and manage pain in endometriosis patients. The technology aims to offer digital therapy alongside medication, using wearable biosensors and AI to quantify pain continuously.
2023-03
Engineering News
Hospital-level care can be delivered at home, says Discovery Health
An August 2022 article discusses how the Biofourmis platform and its Biovitals Analytics Engine, with US FDA clearance, have been used to remotely monitor over 100,000 hospital-at-home patients globally. The platform, developed with Brigham and Women's Hospital, uses AI and advanced analytics to establish patient baselines and detect early clinical deterioration.
2022-08
PMC (PubMed Central)
Observational study on wearable biosensors and machine learning-based remote monitoring of COVID-19 patients - PMC
A peer-reviewed article from February 2021 details an observational study using the Biovitals Analytics Engine for machine learning-based remote monitoring of COVID-19 patients. The cloud-based system, which received FDA 510(k) clearance, generates a Biovitals Index to reflect the overall health status and predict clinical worsening events.
2021-02
PR Newswire
Biofourmis Named 2021 DPHARM Idol Disrupt Winner
This October 2021 press release announces Biofourmis as the 2021 DPHARM Idol Disrupt Winner, highlighting how the Biovitals Analytics Engine, FDA-cleared in 2019, disrupts clinical research by providing continuous, personalized physiological monitoring for early detection of clinical deterioration. The platform's AI capabilities help in identifying clinically significant patterns and improving patient safety in drug development.
2021-10
Biofourmis (Press Release)
Biofourmis' Biovitalsu2122 Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring
In October 2019, Biofourmis announced that its machine-learning and AI-powered Biovitalsu2122 Analytics Engine received 510(k) clearance from the U.S. FDA for ambulatory physiological monitoring. This milestone establishes the solution as a foundation for future disease-specific predictive management tools across various therapeutic areas.
2019-10
Medical Device Network
FDA approves Biofourmis' Biovitals Analytics Engine
An October 2019 article reports on the FDA's 510(k) clearance for Biofourmis' Biovitals Analytics Engine for ambulatory physiological monitoring. The AI-powered engine is designed to process multiple physiological signals and forms the basis of the company's digital therapeutics product pipeline.
2019-10
HCPLive
FDA Approves Artificial Intelligence-Based Physiological Monitor
This October 2019 article discusses the FDA's 510(k) clearance of the Biovitals Analytics Engine, an AI and machine learning device for ambulatory physiological monitoring developed by Biofourmis. The engine processes physiological data to alert providers to changes in vital signs, potentially weeks before a critical event, aiming to reduce hospital readmissions.
2019-10

Videos

Product demos, reviews, and walkthroughs for Biovitals Analytics Engine.

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Frequently Asked Questions

The Biovitals Analytics Engine uses AI and machine learning to process real-time physiological data from FDA-cleared sensors, creating an individualized biometric signature for each patient. It generates a 'Biovitals Index' that alerts physicians to subtle changes from a patient's baseline, potentially predicting clinical decompensation weeks in advance to enable timely interventions and reduce hospital readmissions.
The Biovitals Analytics Engine has received 510(k) clearance from the U.S. FDA as a medical device for ambulatory physiological monitoring, signifying its regulatory approval for its intended use. However, it is intended as an adjunct to vital signs monitoring and not for making clinical treatment decisions or diagnostic purposes.
Physicians should understand that the Biovitals Analytics Engine is not a diagnostic tool and should not replace traditional vital signs monitoring or direct clinical judgment. Its output, the Biovitals Index, is for intermittent, retrospective review by a qualified practitioner to provide additional information for routine patient monitoring.
Several other remote therapeutic monitoring (RTM) and healthcare analytics platforms exist, such as Mahalo Health, Teladoc Health, Athelas, and various solutions from companies like Inovalon and MEDITECH. These alternatives offer diverse functionalities for patient monitoring, data analysis, and clinical decision support.
Specific pricing details for the Biovitals Analytics Engine are not publicly disclosed in the available information. Typically, such enterprise-level healthcare AI solutions involve custom pricing models based on the scale of deployment, integration needs, and specific features required by healthcare institutions.
While specific technical details on data security and privacy protocols are not extensively detailed in publicly available information, as an FDA-cleared medical device, the Biovitals Analytics Engine is expected to comply with relevant healthcare data protection regulations like HIPAA. Healthcare providers should inquire directly with Biofourmis for comprehensive information on their security architecture and data handling policies.
The Biovitals Analytics Engine is designed to receive physiological data from FDA-cleared sensors and stores its output in a cloud-based database, accessible via API for review by practitioners through a dashboard. While direct EHR integration details are not specified in the provided information, interoperability is a common requirement for such platforms in healthcare settings.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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