Sathya Elumalai found it difficult to cope with his mother’s health after she was diagnosed with four chronic conditions. Instead of guessing her health status for the day, he decided to become a co-founder of Aidar Health to get that information directly and reliably.
Founding Aidar, Elumalai also created and launched MouthLab, a device that it claims tracks 10 key health parameters in less than a minute. The company was part of the Battlefield 200 at australiabusinessblog.com Disrupt 2022.
“For a car you have this check engine light that helps you say, now it’s time for you to take your car [to a] dealer or technician to have it repaired. Likewise, our device acts as a way to monitor your health every day, to provide a more holistic view of an individual’s health,” Elumalai said. “So if there [are] any deviations or changes in that health from their baseline, the device can alert and inform the user about those changes, and what they can do to help manage their health. Or use the same data to communicate with their doctor or healthcare providers to better assess health status or changes or abnormalities in health at a very early stage.”
A user holds the iPhone-sized device and places his mouth on the mouthpiece, breathes normally and places his hands on the device as instructed. The company claims that MouthLab will record temperature, respiratory rate, heart rate, blood pressure, breathing pattern, heart rate, heart rate variability, EKG, spirometry (i.e., lung function), and oxygen saturation. Data is collected from sensors on the device from saliva, respiration, hand pulse and lips to read the parameters of the body.
In a world where digital and remote care has become the new normal due to the COVID-19 pandemic, doctors have often had to rely on what their patients say, which is a good starting point, but not enough for long-term care. While tests and labs will eventually be conducted, there has been no efficient way to monitor a patient’s vital signs at home.
Aidar Health was able to obtain Class II FDA 510(k) approval earlier this month. The approval states that the device may pose a moderate risk to users, but allows the company to introduce and market the product for commercial distribution. It is unclear what risks the approval related. According to the company, the device has undergone three clinical trials and is embarking on a study in collaboration with the VA Health System.
Today, there are more than 800 active users of MouthLab and Aidar Health, who use it for remote vital sign monitoring, chronic care management and other home health services — as well as “real-world evidence-generation efforts with life science companies,” Elumalai said. the latter presumably means participation in studies).
“The device is being used for Remote Physiological Monitoring (RPM), Chronic Care Management (CCM), Hospital at Home (H@H) services with health systems and digital biomarker development, digital companion and real-world evidence generation efforts with life scientific companies,” Elumalai told australiabusinessblog.com.
The Maryland-based company claims to be HIPAA compliant by using its own LTE/cellular network cloud. Once data is collected, it is sent to users via the mobile app and then sent to physicians via Fast Healthcare Interoperability Resources, an API for electronic health records.
The company has decided to operate on a subscription model, which costs $50 to $80 per patient per month. Users get MouthLab, access to the web and mobile apps, and doctors can collect vital data and analytics. Prices may vary depending on how you use the service.
“It’s hard to really decipher what patients are really going through,” Elumalai said. “But a device like this, before we even get a telemedicine doctor, we can get the data to them immediately. This gives them a complete snapshot of the patient’s medical history, a longitudinal analysis of the data from the past few days.”