Summary: Happy Health and EnsoData have partnered to offer an at-home solution for diagnosing sleep apnea through the wearable Happy Ring. Utilizing EnsoSleep PPG, an FDA-cleared software as a medical device (SaMD), the ring delivers clinical-grade sleep monitoring and enables patients to obtain a diagnosis and start personalized care within three days. The collaboration aims to address the underdiagnosis of sleep apnea and provide an alternative to traditional sleep testing, particularly benefiting patients who face barriers to in-lab testing due to cost and complexity.
Key Takeaways:
- Accelerated At-Home Diagnosis: The partnership allows for a sleep apnea diagnosis and care initiation within three days, aiming to streamline the testing process for patients.
- FDA-Cleared Wearable Technology: Sleep data from Happy Ring is shared with EnsoData over the cloud, and the FDA-cleared EnsoSleep PPG SaMD provides a sleep apnea diagnosis.
- Accessibility in Sleep Medicine: By moving diagnostics to a wearable device, the partnership addresses underdiagnosis in sleep apnea, particularly for patients deterred by traditional, costlier testing options.
EnsoData and Happy Health, manufacturer of the Happy Ring, announce a partnership to meet the demand for simple, clinical-grade nightly sleep monitoring in the home.
Happy Health’s platform, Happy Sleep, allows patients to directly receive a US Food and Drug Administration (FD)-cleared sleep test powered by EnsoSleep PPG, see a board-certified sleep doctor, and begin personalized care with continuous monitoring from their own home, all in three days.
Sleep apnea remains significantly underdiagnosed. It impacts tens of millions of Americans and often leads to many serious comorbid health complications including heart failure, cardiovascular mortality, stroke, and blood pressure changes. The partnership between Happy Health and EnsoData aims to address this patient population, especially those kept out of traditional care pathways because of their complexity and cost, by offering a more accessible home testing process that the companies say will expedite the patient care journey and get patients on the therapy they need faster.
“In the world of healthcare, harmonizing medical accuracy with consumer wearability has always been a challenge for medical devices. If they’re not comfortable, people won’t wear them; if they’re not accurate, the data is useless,” says Dustin Freckleton, MD, founder and CEO of Happy Health, in a news release. “With this collaboration with EnsoData, Happy Ring is setting a new standard for home sleep testing.”
Sleep Data from Ring Analyzed for Sleep Apnea Diagnosis
Cleared by the FDA in October 2024, the Happy Ring is a wearable medical device that collects clinical-grade individual data points each night. This sleep data is shared with EnsoData over the cloud, and the FDA-cleared EnsoSleep PPG SaMD provides a sleep apnea diagnosis and customized sleep report for physicians.
“We are excited to see the Happy Health team grow with the adoption of EnsoSleep PPG to expand the diagnostic capability of Happy Ring sleep data,” says Justin Mortara, PhD, CEO, and president of EnsoData, in a release. “As care moves increasingly to the home, patients need wearable form factors designed with long-term use in mind and physicians need a trusted AI partner to analyze the growing amount of data collected.”
Freckleton adds in a release, “The future of healthcare is not within the four walls of a distant hospital but instead in a patient’s own home. There’s nothing quite like resting in your own bed. And nowhere is this better understood than in sleep medicine. We’re thrilled to be ushering in a new era of healthcare, starting with sleep medicine.”
Photo caption: Happy Ring
File Photo/Happy Health
Leave a Reply