What Safe Heart does

Safe Heart USA, Inc. is an Atlanta-based, privately held medical device company founded in 2008-2009 by Yale Zhang (CEO) that designs and commercializes affordable, smartphone-connected medical devices and offers commercialization services to other medical hardware innovators. The company's product portfolio centers on the iOX (iOximeter) — a battery-free, FDA-cleared (2019) smartphone pulse oximeter that draws power directly from a mobile phone — plus the MobiCuff adapter (converts a standard blood pressure cuff into a smartphone-connected monitor, developed with Oxford's OxCAHT team) and a $20 pediatric pulse oximeter prototype built on a $50,000 Atlantic Pediatric Device Consortium grant. Hardware is sold direct-to-consumer through oxygenislife.io and wholesale via Clinical Guard, a Yale-co-founded distributor that has served millions of customers since 2006.

The company's business model is a hybrid of low-margin hardware sales (single-digit to low-tens-dollar price points) and a higher-value services arm — Rapid R&D, Manufacturing Consultancy, and ResQLab Support — that helps medical device startups take products from concept through regulatory clearance and manufacturing. This services arm was formalized after 2019, leveraging lessons from the iOX's decade-long development cycle. Safe Heart markets through a company blog, YouTube viral campaigns, an Indiegogo launch (2013), and direct contact forms. Total disclosed funding is $130,000 across two 2014-2015 grants; the company has 1-10 employees, is founder-owned, and does not disclose revenue. Yale University is a foundational collaborator (not a corporate parent), with no evidence of an equity relationship.

Customer segmentation is vertical: the primary target is medical device startups and individual innovators needing end-to-end commercialization support, with a secondary segment of consumers and healthcare providers seeking affordable pulse oximetry and blood pressure monitoring hardware. Three named testimonials on the company website (Wayne Pan MD, Prof. Gari Clifford, Saman Jayasingh MD) reflect development collaborations rather than scaled enterprise customers. The company's stated competitive advantage is end-to-end service at unusually low capital intensity ($80,000 to fully commercialize MobiCuff), anchored by FDA-cleared, smartphone-powered device technology.

Name

Safe Heart

Legal name

Safe Heart USA, inc.

Website

https://safeheartus.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

1–10 employees

Short description

Safe Heart USA is an Atlanta-based medical device company that designs affordable, FDA-cleared, smartphone-connected health devices (iOX pulse oximeter, MobiCuff blood pressure adapter) and offers commercialization services — including R&D, manufacturing consultancy, and ResQLab support — to medical hardware startups and innovators.

Ownership category

akta.pro rank

Product category

Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Pulse Oximeters & Respiratory Monitors (Consumer) (CRACAQAF)

akta.pro secondary industries

Connected Medical Devices & Wearables (Sensors, Patches, Implantables) (HLACAPAB), Clinical-Grade Vital Signs Monitoring (ECG, SpO2, BP, Temp, Respiration) (HLACAPAI)

Keywords

• Medical device development
• Smartphone pulse oximetry
• Blood pressure monitoring
• Healthcare R&D services
• FDA cleared medical devices

Headquarters

HQ city

Atlanta

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales

Revenue model

1. Medical Device Product Sales: Sale of proprietary medical devices including pulse oximeters (iOximeter/iOX) and blood pressure monitoring adapters (MobiCuff) to consumers and healthcare providers.
2. R&D and Manufacturing Services: Consulting services for rapid R&D, manufacturing consultancy, and product development support for other medical device companies.
3. Grant Funding: Research grants from organizations such as the Atlantic Pediatric Device Consortium ($50,000 grant for pediatric pulse oximeter development).

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Safe Heart designs, develops, and commercializes affordable smartphone-connected medical devices, including the FDA-cleared iOximeter/iOX pulse oximeter, MobiCuff blood pressure monitor adapter, and a pediatric pulse oximeter. The company also provides end-to-end commercialization services—rapid R&D, manufacturing consultancy, and ResQLab emergency product turnaround—for medical hardware innovators and startups.

Product overview

Safe Heart USA offers a portfolio of affordable medical devices including the iOximeter/iOX (FDA-cleared smartphone pulse oximeter), MobiCuff (smartphone blood pressure monitor adapter), and the $20 Pediatric Pulse Oximeter. These devices are complemented by commercialization services including Rapid R&D, Manufacturing Consultancy, and ResQLab Support, helping medical device innovators bring products from concept to market.

Differentiator

Problem solved

Functional benefit

Brands

• MobiCuff: An adapter that converts a sphygmomanometer blood pressure cuff into a smartphone blood pressure monitor. Developed by a team from Oxford Centre for Affordable Healthcare Technology.
• iOximeter
• iOX
• ResQLab
• Clinical Guard

Products and services

• iOximeter / iOX Smartphone Pulse Oximeter Smartphone pulse oximeter that measures blood oxygen levels by drawing power directly from a mobile phone, featuring a non-disposable, rugged probe. FDA-cleared medical device for consumers and healthcare providers.
• MobiCuff Blood Pressure Monitor Adapter Adapter device that converts a standard sphygmomanometer blood pressure cuff into a smartphone-connected blood pressure monitor. Originally developed by Oxford Centre for Affordable Healthcare Technology team.
• Pediatric Pulse Oximeter Medical-grade $20 pulse oximeter designed for pediatric use, drawing power directly from mobile phones with a non-disposable, rugged probe. Built to address the Bill and Melinda Gates Foundation call for an affordable pediatric oximeter.
• Rapid R&D Service Focused research and development services to expedite successful medical device product outcomes, aligning funding with product goals. For medical device startups, innovators, and healthcare hardware companies.
• Manufacturing Consultancy Consultative services spanning from test production to full-scale manufacturing, including low minimum order quantities for seamless transitions from ideation to market-ready products. For medical device companies and innovators.
• ResQLab Support Emergency intervention services for troubleshooting production complications, customer dissatisfaction, and financial constraints to ensure successful medical product launches. For medical device companies facing production or product issues.

Quantifiable outcome

• Developed medical-grade $20 pediatric pulse oximeter prototype within grant budget
• +2 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core.

• Oxford Centre for Affordable Healthcare Technology (OxCAHT)coreStrategic or Co-development Partner · 1 January 2014Original developers of MobiCuff technology - a team of five scientists (Carlos Arteta, Joao Domingos, Marco Pimentel, Mauro Santos, Mohammad Ali Maraci) led by Prof Gari Clifford. Core technology won Dell Innovation Challenge in 2012.
• Yale UniversitycoreStrategic or Co-development Partner · 1 January 2013Yale co-founded Clinical Guard in 2006 and collaborated with Safe Heart on product development including iOximeter and MobiCuff projects.
• Clinical GuardcoreChannel Partner/ Reseller/ Distributor · 1 January 2006Medical device distributor co-founded by Yale in Atlanta. Brings affordable pulse oximeters, nebulizers, fetal Dopplers, and pregnancy/ovulation test strips to market. Has served millions of customers.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Masimo: Masimo is a global leader in pulse oximetry and patient monitoring; it is the most direct incumbent in clinical-grade and consumer pulse oximetry (it won the Gates Foundation pediatric oximeter RFP that Safe Heart competed for), making it a key benchmark for Safe Heart's iOX and pediatric products.
• Nonin Medical: Nonin is a long-established manufacturer of medical-grade pulse oximeters and sensors used in clinical and home settings; comparable to Safe Heart's iOX positioning as a medical-grade, low-cost oximetry device.
• Contec Medical Systems: Contec manufactures low-cost patient monitoring devices including pulse oximeters widely sold through Clinical Guard-style channels; it is a relevant competitor on price-sensitive consumer and clinical oximetry.
• Beurer: Beurer is a European consumer health device maker offering pulse oximeters, BP monitors, and thermometers; comparable to Safe Heart's portfolio of affordable smartphone and standalone vital signs devices.
• Omron Healthcare: Omron is a major manufacturer of consumer and clinical blood pressure monitors, including smartphone-connected models; it competes most directly with Safe Heart's MobiCuff product.

Direct peers

• AliveCor (KardiaMobile): AliveCor makes FDA-cleared smartphone-connected ECG devices (KardiaMobile), a directly comparable business model of consumer-grade, FDA-cleared medical hardware that runs through a phone.
• Withings: Withings builds connected consumer health devices (BP monitors, sleep, smart scales) that pair with smartphones; it competes with Safe Heart's iOX and MobiCuff in the consumer smartphone-connected vitals category.
• Qardio: Qardio produces smartphone-connected blood pressure monitors and other consumer vitals devices, making it a direct adjacent peer to MobiCuff in the connected BP category.
• iHealth Labs: iHealth Labs (a subsidiary of Andon Health) makes smartphone-connected vital signs devices including pulse oximeters, blood pressure monitors, and thermometers; this is the closest direct peer in smartphone-connected consumer medical devices.

Emerging players

• Oxitone Medical: Oxitone develops wearable, continuous pulse oximetry monitors for remote patient monitoring; it overlaps with Safe Heart's iOX in medical-grade SpO2 monitoring delivered through a connected device.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights6 records

Customer concentration

• Xx.com/mobicuff
• Facebookfacebook.com/mobicuff
• LinkedInlinkedin.com/company/safe-heart-usa-inc.

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Safe Heart