OxiWear’s Ear-Wearable Tech Brings Real-Time Oxygen Measurement to Life 

Conditions like pulmonary hypertension and hypoxia can severely impact the quality of life and, if left unaddressed, can be fatal. Shavini Fernando understands this reality all too well. Her own battle with severe pulmonary hypertension and silent hypoxia served as the catalyst for developing a continuous, real-time oxygen measurement solution: OxiWear. Fernando is the Founder and CEO of OxiWear. We spoke with her to understand the journey behind OxiWear, the challenges she overcame, and the impact her innovation is making.     

“Traditional pulse oximeters proved unreliable during movement and were not designed for continuous measurement,” Fernando explained. “Facing multiple near-fatal hypoxic episodes, I was determined to create a wearable device that could provide real-time low-oxygen alerts and prevent life-threatening situations.” 

Overcoming Challenges in Development 

Developing OxiWear came with significant challenges. One of the primary hurdles was technology development, as creating a small, wearable, and accurate continuous oxygen measurement device required extensive research and innovation. “It wasn’t just about making a device; it was about ensuring accuracy, reliability, and usability in real-world conditions,” Fernando noted. Navigating the FDA clearance process added another layer of complexity, requiring rigorous validation and clinical testing. “Getting FDA clearance was crucial, but it meant years of regulatory work and proving our device met the highest medical standards.” Manufacturing and supply chain management posed additional difficulties in ensuring high-quality production while maintaining affordability and scalability. Additionally, as a first-time entrepreneur, securing funding and convincing investors of the need for such a device was no easy feat. “Many investors are hesitant to support hardware-based innovations, especially with the regulatory hurdles involved,” she added. 

How OxiWear Stands Out 

OxiWear distinguishes itself from traditional pulse oximeters by offering continuous oxygen measurement in a lightweight, wearable format. Unlike standard finger pulse oximeters, which provide only spot readings, OxiWear delivers real-time, uninterrupted measurements and low-oxygen alerts. “We designed OxiWear to work seamlessly even when the user is in motion, something traditional devices struggle with,” Fernando emphasized. “This makes it particularly beneficial for individuals with chronic conditions, high-risk users, and even athletes training at altitude.” 

The Technology Behind OxiWear 

OxiWear relies on photoplethysmography (PPG) technology with advanced signal processing algorithms to ensure continuous and accurate oxygen measurement. Designed for use on the ear, the device provides more stable readings compared to finger-based alternatives, especially during movement. Fernando explained, “The device connects to a mobile app, enabling users and caregivers to measure oxygen levels and receive immediate alerts if oxygen drops to dangerous levels.” 

Prioritizing User Experience 

In designing OxiWear, user experience was a top priority. “We wanted to create something people would actually wear daily without discomfort,” said Fernando. The device was developed to be lightweight and comfortable for extended wear, ensuring it is both functional and non-invasive. Advanced sensor technology guarantees accuracy and reliability, while a discreet design helps integrate the device seamlessly into daily life. “The goal was to make it as easy to wear as a pair of earrings while providing life-saving functionality,” she added. The accompanying mobile app enhances usability by providing real-time measurements, historical trends, and emergency alerts. 

Achieving FDA Clearance 

Receiving FDA clearance marked a major milestone for OxiWear, affirming its effectiveness and safety as a medical device. “This approval enables us to market and sell OxiWear as a prescription medical device, opening doors for hospital partnerships, insurance reimbursement, and broader adoption within the healthcare sector,” Fernando stated. For users, this means access to a clinically validated device that enhances both safety and quality of life.

Securing Funding in MedTech 

Funding has been one of the biggest hurdles for OxiWear. Raising capital in MedTech, particularly for hardware-based innovations, presents unique challenges. “Investors tend to favor software-focused health tech due to its faster scalability and fewer regulatory barriers,” Fernando acknowledged. “The lengthy FDA approval process has also made some hesitant to commit before regulatory clearance.” Additionally, continuous oxygen measurement is a relatively new category, requiring market education to highlight its impact and potential. 

Currently, OxiWear is closing a $2M bridge round to its Series A, with $400K remaining, which the company hopes to finalize by the end of March. A $10M Series A round is expected to open in June. “This funding will support team expansion, research and development of OxiWear 2.0 with enhanced features, and securing FDA clearance for the next-generation device,” Fernando shared. “Combined with our growing revenue, this financial support will help sustain us through the end of 2026.”

Investor Interest and Market Evolution 

Investor interest in MedTech startups has evolved, particularly in the wearable health technology and remote patient monitoring space. However, securing funding remains challenging due to regulatory hurdles and lengthy development cycles. “For founders seeking investment, it’s essential to have a clear regulatory pathway, demonstrate market validation through strong clinical partnerships and user adoption, and remain resilient throughout the process,” Fernando advised. 

Who Benefits from OxiWear? 

OxiWear’s primary users include individuals with pulmonary hypertension, COPD, and other respiratory conditions requiring continuous oxygen measurement. Athletes training at altitude and military personnel at risk of hypoxia also benefit from the device. Early adopters have praised OxiWear for its comfort, accuracy, and life-saving potential, particularly in providing timely alerts for dangerous oxygen drops. “Users have told us that OxiWear has given them peace of mind and even saved their lives in critical moments,” Fernando said. 

Future Innovations and Expansion 

Future iterations of OxiWear will expand beyond oxygen measurement to include additional cardiovascular health metrics and AI-driven health insights. “We envision evolving into a comprehensive wearable health platform designed for proactive disease management,” Fernando noted. 

The future of wearables is in real-time, AI-powered measurement of health vitals, enabling early intervention and personalized care. “Our goal is to be at the forefront of this movement, ensuring that individuals can track and manage their health with greater precision and confidence,” she added. OxiWear aligns with this vision by pioneering continuous oxygen measurement, with potential integration into broader health systems. 

To date, OxiWear has over 200 active users, with its devices having been tested in extreme conditions, including expeditions to Mount Everest and Kilimanjaro. “We wanted to prove OxiWear could perform in the harshest environments, and our tests showed it could detect early signs of low oxygen levels in climbers, allowing for timely interventions and preventing serious health risks. This real-world validation reinforces the reliability and life-saving potential of our technology,” Fernando concluded.