OxiWear

High-Level Overview

OxiWear is a digital health startup founded in 2019 that develops an FDA-cleared ear-wearable device for continuous, non-invasive monitoring of blood oxygen saturation (SpO2) and pulse rate.[1][2][5] The device serves patients prone to low oxygen levels, such as those with pulmonary hypertension or congenital heart disease, including adults (22+) and adolescents (12-21) in hospitals, home care, EMS, and mobile settings.[1][5] It solves the problem of silent hypoxia—dangerous drops in oxygen that go undetected—by providing second-by-second alerts via app, text, and vibration, with high accuracy across all skin tones and during motion, reducing risks of hypoxic injury and enabling proactive care.[1][2][5]

The company has raised $1.43M in grants and investments, including recent awards from APDI and Additional Ventures for pediatric applications, signaling strong growth momentum in wearable medtech.[1]

Origin Story

OxiWear was founded in 2019 in Arlington, Virginia (with ties to Washington, D.C.), by Shavini Fernando, CEO, who drew from her personal experience as a pulmonary hypertension patient to address gaps in oxygen monitoring.[1][3][4] Fernando, with a background in computer science (BSc from University of Portsmouth), MBA (Edith Cowan University), and MA in Communication, Culture, and Technology (Georgetown), brings 15+ years in project management, software development, VR, and user experience design.[4] Key team members include Michael Boncaldo, Senior Software Engineer with 25+ years in embedded systems, machine learning, and regulated industries like medical devices.[4]

The idea emerged from limitations in existing pulse oximeters, which often fail on darker skin tones or during motion, leading to pivotal early traction like FDA 510(k) clearance in 2024 (K233827) and grants for pediatric innovations, including Virginia Venture Partners investment in 2022 for pulmonary hypertension alerts.[1][3][5]

Core Differentiators

• Ear-wearable form factor: Small, sleek, comfortable device uses transmitted, reflected, and scattered light through the ear for accurate SpO2 and pulse rate monitoring while still or in motion, unlike finger/forehead clips that falter with movement or perfusion issues.[1][2][5]
• Inclusive accuracy: Patented technology validated across all skin tones, earning praise from Johns Hopkins for precision in diverse patients, addressing biases in traditional oximeters.[2]
• Real-time alerts and data sharing: Second-by-second tracking with customizable vibration, app, and text notifications to users, caregivers, or clinicians; Bluetooth-connected mobile app for live trending and historical reports.[2][5]
• FDA-cleared versatility: Class II oximeter for spot-check or continuous use in well/poorly perfused patients (12+ years), reusable with charger, supporting home-to-hospital transitions.[5]
• Expert team: Combines patient insight, software engineering, and medtech regulatory experience for seamless hardware-software integration.[4]

Role in the Broader Tech Landscape

OxiWear rides the wearable digital health wave, part of a 11,000+ company ecosystem advancing sensors, AI-driven monitoring, and remote care to cut healthcare costs and improve outcomes.[1] Timing aligns with post-COVID emphasis on home monitoring for chronic conditions like pulmonary hypertension and pediatric heart disease, amplified by regulatory wins like FDA clearance and grants targeting underserved pediatric applications.[1][5] Market forces favoring it include rising demand for motion-tolerant, bias-free vitals tech amid clinician shortages and "hospital-to-home" shifts, plus integrations with telehealth for real-time data sharing.[1][2] By enabling proactive hypoxia prevention, OxiWear influences the ecosystem toward equitable, patient-centered medtech, potentially reducing ER visits and supporting broader adoption of ear-based wearables.

Quick Take & Future Outlook

OxiWear's trajectory points to scaled commercialization, leveraging FDA clearance and pediatric grants to expand into consumer channels, partnerships with health systems, and international markets.[1][5] Trends like AI-enhanced vitals analytics, deeper EHR integrations, and multimodal wearables (e.g., adding ECG or respiration) will shape its path, while reimbursement wins could accelerate adoption.[1][2] Its influence may evolve from niche hypoxia guardian to mainstream chronic care platform, empowering patients to "thrive" independently—echoing its mission to turn vulnerability into freedom through precise, always-on monitoring.[2]