Son creates MouthLab, a FDA-cleared medical device for disease management inspired by his mom

"No warning should ever go unheard." That is the mission of Aidar Health, a company born from a son's frustration. Sathya Elumalai's mother lived with diabetes, hypertension and chronic kidney disease, managing all three at home with devices that couldn't talk to each other, or to her doctors. In his words, she was "the integration layer in a system that was never integrated." So he set out to build what she needed: one device and one signal her care team could trust.
That device is MouthLab, a handheld tool about the size of a smartphone, FDA-cleared as a spot-check vital signs monitor. The user holds it, places the mouthpiece between teeth and lips, and breathes normally. In under a minute, sensors reading the breath, saliva, lips and hands record ten vital parameters, including blood pressure, oxygen saturation, temperature, ECG, respiratory rate and lung function. These parameters compared well against standard hospital monitors in early testings.
Beyond measuring, Aidar has been studying whether these readings can help predict health decline before it becomes an emergency. A study following COVID-19 patients with chronic conditions, completed in early 2024, gathered data to help build a predictive algorithm; a separate study on heart failure patients has examined whether MouthLab readings can flag clinical decompensation. Results from this research are limited so far: the evidence base for MouthLab's predictive capabilities is still being built, distinct from its FDA clearance as a vital-signs monitor.
Elumalai says he tests every decision with one question: “would this have helped my mom?”. And, through this thought process, he is developing a solution that could help many patients with chronic diseases and their caregivers.
Aidar was founded in 2018 in partnership with Johns Hopkins, and today MouthLab is FDA-cleared, has been used with more than 1,000 patients in long-term care facilities, and Aidar has been accepted into the CMS ACCESS Model, which began in July 2026.

Adapted from:
https://phys.org/news/2015-08-mouthlab-patients-vital.html
https://clinicaltrials.gov/study/NCT05713266
https://www.healthcareitnews.com/news/cms-announces-150-participants-upc...
https://www.healthcareitnews.com/news/cms-announces-150-participants-upc...
https://clinicaltrials.gov/study/NCT05713266
https://clinicaltrials.gov/study/NCT04757246

https://www.youtube.com/watch?v=CSw-m69J4mg