Linked research, clinical, and regulatory source pathways.
Company profile
About iHealth Labs
iHealth Labs Inc. is a medical device and consumer healthcare company that has been a leader in health monitoring innovation since 2010. The company designs and manufactures award-winning vitals monitoring devices and at-home diagnostic tests that help people of all ages take a more active role in managing their health. iHealth's product portfolio includes wireless blood pressure monitors, smart glucose monitoring systems, pulse oximeters, thermometers, body composition scales, and rapid diagnostic tests for COVID-19 and influenza. During the COVID-19 pandemic, iHealth emerged as a major supplier of at-home tests to the U.S. federal government, delivering over 1 billion tests through federal contracts and becoming the #1 at-home COVID test supplier based on government contracts and retail sales data. The company's orange box COVID-19 test became a household name through the federal government's free test distribution program and nationwide media coverage. Beyond consumer products, iHealth operates a Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) program called Unified Care, designed to help healthcare providers manage patients with chronic conditions while generating additional revenue. The platform integrates iHealth's connected devices to enable continuous monitoring and better patient outcomes. iHealth's devices are known for their clinical accuracy, user-friendly design, wireless connectivity, and integration with mobile apps for data tracking and sharing with healthcare providers.
Company description iHealth Labs official website
Primary marketChronic Disease Management & Digital Therapeutics
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Chronic diseases
- COVID-19
- Diabetes
- Hypertension
- Influenza A
- Influenza B
- Respiratory infections
Who it serves
- Consumers
- Government agencies
- Health systems
- Healthcare providers
Deployment & integration
Deployment information is currently being developed.
Geographic context
MarketsUnited States
Company sourceOfficial website
Company milestones
Platform expansion
Launched RSV/COVID-19/Flu A&B 4-in-1 Rapid Test (2024-2025), launched COVID-19/Flu A&B 3-in-1 Rapid Test, supplied over 1 billion COVID tests through federal contracts, received additional $1.3 billion federal contract and 105 million test order
Partnerships
Recorded partners
- Amazon
- CareEvolution
- The Rockefeller Foundation
- U.S. Federal Government
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
No source-backed Company products are currently listed.
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Efficacy of sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists on proteinuria and weight in a diabetes cohort.World journal of diabetes · Feb 15, 2025
Evaluation of LLMs accuracy and consistency in the registered dietitian exam through prompt engineering and knowledge retrieval.Scientific reports · Jan 9, 2025
The COVID-19 vaccination hesitancy among Chinese individuals with diabetes and the impact on glycemic control of vaccination: a questionnaire study.BMC endocrine disorders · Dec 23, 2022
A Mobile-Based Intervention for Glycemic Control in Patients With Type 2 Diabetes: Retrospective, Propensity Score-Matched Cohort Study.JMIR mHealth and uHealth · Mar 11, 2020
A Mobile Phone-Based Gait Assessment App for the Elderly: Development and Evaluation.JMIR mHealth and uHealth · Feb 29, 2020
Clinical validation
Clinical-trial records
Evaluation of COVID-19 and Flu A/B 3 in 1 Combo Rapid TestNCT07190131 · Sponsor · COMPLETED
Covid Flu A/B and RSV 4 in 1 Diagnostic TestNCT07308158 · Sponsor · COMPLETED
Regulatory
Regulatory records
No linked records are currently available.
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Better patient outcomes through chronic disease management
Remote Patient Monitoring program
$200K annual revenue per provider
Through CCM and RPM reimbursement programs
94.3% sensitivity
COVID-19 Antigen Rapid Test in early symptomatic cases
Over 1 billion tests supplied
COVID-19 testing during pandemic
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from iHealth Labs
Recent articles published on iHealth Labs's official website.
No Company updates are currently listed.
07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Chronic Disease Management & Digital Therapeutics
Companies using AI and digital health tools to help patients manage chronic conditions through digital therapeutics, gamified health management, and AI-powered coaching. Covers management of all chronic diseases including diabetes, hypertension, COPD, heart disease, and multi-condition platforms. Includes continuous glucose monitoring (CGM) systems with AI analytics and insulin optimization algorithms.
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