Medicare, some insurance to now cover wearable medical device for PH
Reimbursement will help make Oxiwear oxygen-monitoring tool less costly
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Oxiwear‘s wearable medical device, which continuously tracks oxygen levels in people with pulmonary hypertension (PH) and other heart or lung conditions, will now be covered by Medicare and certain private insurance providers in the U.S., the company announced.
The prescription medical device has been approved by U.S. regulators since 2024 for use by adults and adolescents, ages 12 and older, in both clinical and at-home settings. However, patients using the monitoring device — priced at $500 for the device bundle, according to a company webpage — had previously had to cover its cost out of pocket.
According to the company, the availability of insurance coverage will now make the device more accessible and affordable to those who need it.
“Since receiving [U.S. Food and Drug Administration] clearance, one of our biggest priorities has been solving the reimbursement challenge and ensuring patients can access this technology without creating an additional financial burden,” Shavini Fernando, founder and CEO of Oxiwear, said in a company press release announcing the expansion of insurance coverage for the device.
“Now, more patients can access the continuous oxygen data they need with greater affordability and peace of mind,” Fernando added, noting she is “incredibly proud” of this milestone.
Individuals should check with their physicians and insurance providers to determine their specific coverage levels.
People with all types of PH have elevated pressure in the vessels that carry blood from the heart to the lungs. Consequently, the heart has a harder time pumping oxygenated blood out to the rest of the body.
If oxygen levels drop too low, the body’s organs can’t work as they should, and this can be life-threatening. For one, the heart can stop beating. While doctors check blood oxygen levels in the clinic, this doesn’t capture the daily fluctuations that can happen during exercise, sleep, or other activities in everyday life.
Wearable device developed by woman living with PH
Fernando, who is living with PH due to Eisenmenger syndrome, a complication of untreated congenital heart defects, developed the device as a tool for herself and others to more closely monitor their health and recognize medical emergencies promptly in their everyday lives.
“I started Oxiwear as a personal mission to help people like me live life to the fullest despite the challenges of living with conditions that put us at risk of low oxygen levels,” Fernando said. “I’m incredibly proud that we’ve been able to work through [these] barriers and make OxiWear available through insurance coverage.”
The technology comes in the form of a small device that clips onto the outer rim of the ear. It contains a sensor that continuously monitors blood oxygen levels, whether a person is moving or at rest, and issues real-time alerts when oxygen levels drop too low.
These alerts are customizable, and patients can work with their doctors to determine a safe threshold in their case, according to the company. When the threshold is hit, the device will vibrate to give a warning.
I started Oxiwear as a personal mission to help people like me live life to the fullest despite the challenges of living with conditions that put us at risk of low oxygen levels.
Importantly, according to Oxiwear, the device has proven effective across different skin tones. Oxygen monitoring devices have historically been criticized for being less effective on people with darker skin.
Oxiwear connects via Bluetooth to a person’s smartphone, where they can use a companion mobile app to track their data. This allows text alerts to be sent to designated emergency contacts. The device is also water-resistant, comes with a portable charging case, and enables individuals to monitor battery status via the mobile app.
Beyond PH, the Oxiwear device is designed to support people with various heart and lung conditions, such as chronic obstructive pulmonary disease, interstitial lung disease, cardiovascular disease, and sleep-related breathing disorders. There is also a nonprescription version for people who wish to track general wellness or fitness.
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