Biofourmis

A cleared model is the engine of the monitoring, inside a care service that carries value of its own. The Biovitals Analytics Engine (K183282) takes heart rate, respiratory rate and activity from cleared wearables, establishes each patient's baseline from the first 24 hours, updates it periodically, and outputs a Biovitals Index from 0 to 1 reflecting change from that personal baseline, which is an inference that rules cannot reproduce; the company also holds a clearance for RhythmAnalytics, ECG arrhythmia analysis software (K182344).

The home page sells Biofourmis Care, hospital at home, timely discharge, skilled nursing at home and remote monitoring, delivered with devices, in home services and clinical teams licensed in 25 states, and the 2024 merger with CopilotIQ added nursing visits for chronic care. People and hardware deliver much of what reaches the patient, so the model is the engine of a core module rather than the whole product.

Clinicians are structurally in the loop, and the escalation rules are not published. The cleared analytics engine (K183282) is indicated for daily, intermittent, retrospective review of the Biovitals Index by a qualified practitioner and not for clinical decisions, and the home page describes care delivered with clinical teams licensed in 25 states; the chronic care business added through the CopilotIQ merger employs nurses who make home visits.

The platform detects and alerts and a clinician decides whether to call, visit, adjust medication or escalate. What is missing is the failure direction that matters most: the home page sells acute hospital at home and deterioration detected 21 hours sooner, which implies faster review than the daily retrospective use in the clearance, and nothing states alert thresholds, coverage hours, acknowledgment requirements, or how a missed deterioration is reviewed. The heart failure dosing product (Breakthrough designation, 2021) would move closer to a treatment recommendation.

The approach is named in the company's own filing, without the performance and update discipline behind it. The Biovitals Analytics Engine summary (K183282) describes cloud software with a proprietary algorithm that establishes a personal baseline from the first 24 hours of heart rate, respiratory rate and activity data, updates it periodically, and outputs a Biovitals Index from 0 to 1 reflecting change from baseline, with PhysIQ's personalized physiological analytics engine (K142512) as predicate; RhythmAnalytics (K182344) is cleared ECG analysis software.

No sensitivity, specificity, false alarm rate or positive predictive value for deterioration detection is published (the summary reports only that agreement's lower confidence bound exceeded 0.7 on 50 subjects), and no model card, retraining cadence, drift monitoring or version history is published, so a customer cannot tell where the product sits between missed events and alarm fatigue or when it changed.

The recipients are described in outline, and no model provider, host or register is named. The company's patient privacy policy (effective 5 February 2021) places data with a cloud service provider whose servers are in various jurisdictions, handles protected health information under business associate agreements with covered entity clients, shares aggregated de-identified data with partners and the public under contracts that bar re-identification, and names Google Analytics, Facebook, Pinterest and Google Ads among the tools on its sites. The deterioration analytics are the company's own cleared software (K183282), so no outside model provider is described in the analytic path.

No subprocessor register, cloud provider name or third party component inventory is published. The analytics engine takes data from already cleared sensors (K183282) without naming them on the company's pages, although the company's own Everion+ devices are cleared (K213863, K233418); which devices a program uses and who provides home connectivity are not stated, and a device change alters what the models see. The labor chain, virtual clinical teams, in home service orchestration and nursing visits, may be employed or subcontracted, and nothing says which. The merger with CopilotIQ combined two device fleets, platforms and service organizations, and the trials business moved to ActiGraph, with no inventory of what now sits where.

An architecture described with no host or model provider named.

Named customers and a regulatory designation, with headline outcome figures that carry no method. The home page claims a 70 percent reduction in 30 day readmissions and deterioration detected 21 hours sooner, with no cohort, comparator, denominator or source.

Named programs include AdventHealth (selected in January 2025 for acute care at home), Lee Health, UCI Health, Community Health Network, Augusta University Health under a four year collaboration and Orlando Health under a multi year agreement, and GE HealthCare announced a partnership in February 2024 to extend hospital monitoring into the home. The cleared analytics engine's summary (K183282) reports correlation testing on 50 emergency department subjects. BiovitalsHF's Breakthrough Device Designation (2021) is granted on preliminary evidence and is not a finding that the device works. The company cites no peer reviewed outcome study.

Categorical commitments are published for the product, and the retention schedule sits in contracts that are not. The company's patient privacy policy (Biofourmis Inc., effective 5 February 2021, published on its platform domain) applies to its wearable medical devices, the Biovitals remote patient monitoring platform, software, web and mobile applications and related services. It says the company acts as a business associate of its covered entity clients and uses and discloses protected health information only as those business associate agreements allow; that protected health information is kept for the period the agreement with the client specifies; and that the company may use anonymized and de-identified data to research, understand and improve its service and share aggregated de-identified data with partners and the public, with contracts barring recipients from re-identifying it. It lists the data collected: account details, and from device activation heart rate, respiration, blood pulse wave and body temperature, plus sync events with device serial number and battery level.

What is not published is the retention period itself, which sits in each client agreement, the de-identification method, and whether de-identified patient data trains the deterioration models. Continuous monitoring produces a behavioral record as well as a clinical one, and nothing covers devices returned and reissued to another patient. No safety engineering is published. The policy predates the current Biofourmis Care branding and the 2024 merger with CopilotIQ.

Categorical, contract bound commitments without a retention schedule.

A privacy document that reaches the product states the company's business associate status, and the agreement is not published. The company's patient privacy policy (Biofourmis Inc., effective 5 February 2021) applies to its wearables, remote monitoring platform and applications and states that the company is a business associate of its covered entity clients, using and disclosing protected health information only under those business associate agreements, with retention set by each agreement and administrative, technical and physical safeguards under HIPAA. The website privacy policy separately refers protected health information to a HIPAA Notice of Privacy Practices, which fits the licensed care operations the home page describes in 25 states.

The agreement's tier, breach notification window, audit rights, data return provisions and subcontractor terms are all unpublished. Three features raise the obligations: data originates in patients' homes from devices the company supplies, its clinical staff enter homes and access records, and the trials business was sold to ActiGraph in January 2025, so where research data from that business now sits is not stated.

No security certification, audited report, penetration testing statement, vulnerability disclosure route or trust surface is published; the site footer links only a privacy policy, terms of service and a patents page, and the privacy policy says only that the company uses reasonable endeavors to keep personal data secure. Large health systems' procurement ordinarily requires audited reports, so one may exist; none is published.

The attack surface is broader than a software estate: connected medical devices in patients' homes on consumer connections, physically accessible to anyone in the house, with firmware and provisioning questions of their own, and two separately built platforms combined in the CopilotIQ merger, with nothing describing a single security program. The company's site also still shows placeholder text in its navigation menus.

The clearances are identifiable, and the marketed use goes beyond the cleared one. FDA's database lists four 510(k) clearances held by Biofourmis Singapore Pte. Ltd.: RhythmAnalytics (K182344, March 2019, product code DQK, ECG analysis software), the Biovitals Analytics Engine (K183282, August 2019, code PLB, 21 CFR 870.2300), the Everion+ System (K213863, February 2023, MSX) and Everion+ G2 (K233418, May 2024, MSX); BiovitalsHF, for heart failure medication optimization, received Breakthrough Device Designation in 2021, which is not a clearance.

The analytics engine is indicated for adults monitored at home or in a facility, using heart rate, respiratory rate and activity from cleared sensors, for daily, intermittent, retrospective review by a qualified practitioner, and not for clinical decisions or diagnosis. The home page sells acute hospital at home and deterioration detected 21 hours sooner, a timelier use than the clearance describes.

Nothing published describes how the models are governed or how they perform across patient groups. The Biovitals Analytics Engine summary (K183282) reports clinical testing on 50 emergency department subjects with no subgroup analysis, and no bias testing, fairness review, sensor validation across skin tones, governance framework or model documentation appears on the company's site. Two mechanisms bear on this product.

Wearables that derive heart rate and oxygen saturation optically can read less accurately through darker skin, and a platform inherits what its sensors miss: a patient whose deterioration the sensor understates produces no alert rather than a false one. And the personal baseline is set from the first 24 hours, so a patient who enrolls while unwell has every later judgment anchored to an unrepresentative baseline, with nothing described about how a poor baseline is detected.

A clinician review step is part of the cleared use, and nothing stands behind the output. The Biovitals Analytics Engine's indication (K183282) is daily, intermittent, retrospective review of the Biovitals Index by a qualified practitioner, not clinical decisions or diagnosis, so a clinician sits between the index and any action.

Its clinical testing on 50 emergency department subjects reports only that the positive percent agreement's lower confidence bound exceeded 0.7, with no figure, event count or false alert rate, which is not an error rate for detecting deterioration. No indemnity, warranty, accuracy guarantee, alert delivery commitment or dispute route is published. The home page's claims, deterioration detected 21 hours sooner and a 70 percent reduction in 30 day readmissions, carry no method or source.

In acute care at home the harm the product exists to prevent is a patient deteriorating unnoticed, and nothing says how fault divides between the health system, the vendor's devices, connectivity and the model.

Integration is claimed at the level of outcome and no system is named. The platform is sold to health systems running hospital at home, timely discharge and skilled nursing at home programs, which need record integration, the merged company presented a single technology across the care continuum, and GE HealthCare's February 2024 partnership points to device level interoperability with hospital monitoring. The cleared analytics engine exposes web APIs (K183282).

No record system, integration standard, direction of data flow or write back content is named, and for home monitoring the write back choice (every reading, daily summaries, alerts or escalations only) decides whether the hospital record holds a usable account of the home stay. The home end, devices and connectivity in houses with poor coverage, is not described.

Nothing published says where the monitoring platform's data rests. The cleared analytics engine is described in its 510(k) summary (K183282) as cloud based software with a cloud database and web APIs, without a provider or region; the patient privacy policy (effective 5 February 2021), which reaches the wearables and the monitoring platform, and the website privacy policy both say data sits with a cloud service provider whose servers are located in various jurisdictions.

That describes a hosted service and commits no location. No tenancy statement, residency position, recovery objective, availability commitment or failover description is published. For acute care at home an outage means patients admitted to be watched are not watched, which makes availability the most important operational commitment, and the company's Singapore origin and cleared devices filed by its Singapore entity raise a residency question it does not answer. Whether the CopilotIQ and Biofourmis platforms share infrastructure after the merger is not described.

Nothing a buyer can use to size the cost is published: no pricing page, unit of charge, range, tier, implementation fee or minimum commitment. The offering bundles software, clinical grade wearables, in home service orchestration, virtual clinical teams and, since the CopilotIQ merger, nursing visits, so cost carries licensing, hardware, logistics and labor, and nothing indicates which are included or optional.

Hospital at home and remote monitoring are funded through billing pathways with their own rules and rates, so a health system's question is whether the program clears its cost, and nothing published helps it answer.

Coverage runs across levels of acuity, and only part of it is backed by named programs. The home page sells hospital at home, timely discharge, skilled nursing at home and remote patient monitoring, with licensed operations in 25 states, and the merged company describes a span from pre surgical optimization through acute care at home, post acute recovery and chronic management of heart failure, hypertension, diabetes and lipids.

Named hospital at home programs (AdventHealth, Lee Health, Orlando Health, Augusta University Health) stand behind the acute setting; the chronic business arrived through the CopilotIQ merger and is described at company level, and the clinical trials business was sold to ActiGraph in January 2025. The cleared analytics engine is indicated for ambulatory adults at home or in a facility.