Recognizing the potential of MouthLab in clinical trials and chronic care management, Aidar Health was awarded the prestigious National Science Foundation SBIR funding in 2020 to accelerate the development of a scalable and flexible cloud-based enterprise platform for physicians to capture and analyze MouthLab and/or external device data. This is a profound improvement that would enable person-centered care to become a reality,' says Jenny Mathew, co-founder and Chief Nursing Officer at Aidar Health. Especially for individuals with chronic diseases experiencing sporadic care and reactive care, Aidar’s technology would enable efficient condition management at home through real-time data transfer and communication with their care provider. “This is a defining moment for the digital medicine sector and we are excited to finally bring our device and proprietary technology to clinicians, scientists, and patients who need it most.

Our focused approach and commitment to developing medical-grade devices that are clinically-validated and cleared by the FDA is a key pillar of the company’s long-term vision and pivotal to secure the trust of not only the users and caregivers but also our partners including healthcare providers, pharmaceutical companies, clinical research organizations, and health plans.” Ankitha Nair, Head of Quality and Regulatory Affairs at Aidar Health says, “The COVID-19 pandemic has helped accelerate the proliferation of remote monitoring technologies including devices that are directed at non-regulated consumer-oriented applications. This 510(k) clearance of the MouthLab from the FDA comes close on the heels of the CE Mark Approval received by Aidar Health in early February. “I’m extremely proud of our team’s achievement overcoming all the challenges posed by the pandemic to receive this clearance, especially considering the fact that this clearance covers 10 vital medical parameters in a single 510(k) application.' “This landmark approval is a great validation of the technology and our broader thesis that rapid simultaneous measurement of a set of vital signs is a key enabler to the transition from standardized to personalized healthcare for all,” said Sathya Elumalai, CEO and Founder of Aidar Health. By combining the insights from all the vital health parameters, MouthLab can create a new kind of personalized, people-centric experience that empowers individuals to make sustainable behavior and lifestyle changes and improve health outcomes. MouthLab, paired with telemedicine can drastically reduce the burden on the healthcare system by effectively screening individuals at home and at other healthcare facilities, diverting traffic from emergency departments and providing data for clinicians to prudently allocate resources. Gene Fridman and Sathya Elumalai in partnership with clinicians from the prestigious Johns Hopkins Medical Institute. MouthLab was designed and developed by Dr.

Aidar Health, Inc., a healthcare technology and digital medicine company, today announced it has received FDA Class II 510(k) clearance for its first product, MouthLab, a hand-held, non-invasive, rapid health assessment, and remote monitoring device that measures 10 vital health parameters in 60 seconds.

Fda 510k database