Biostrap, a high-resolution biosensor-based digital biomarker platform pioneering the space of clinically reliable biosensors, data processing techniques and remote physiological monitoring, will soon release Ethos, a wearable technology using continuous raw photoplethysmography (PPG) data in health care research and patient care.
In preparation for submitting for FDA 510(k) clearance during Q1 2023, Biostrap recently concluded a clinical study performed by the Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care at the University of California, San Francisco to validate Ethos' blood oxygen saturation (SpO2) measurements against a co-oximetry blood test using an arterial blood sample (saO2).
The results concluded that Biostrap's SpO2 data capture achieved 2.7% root-mean-square-error (RMSE), exceeding the FDA's 3.5% requirement to apply for FDA Class II medical device certification.
With previous partnerships with UCLA, Children's Hospital Los Angeles, Stanford University and Tulane University School of Medicine, the digital health company's next step to immerse itself even deeper in the health care industry comes as no surprise.
Utilizing Biostrap's current suite of devices, API, SDK and remote monitoring platform, researchers have been able to develop a novel biomarker for Sickle Cell Disease, monitor disease progression of COVID-19 and will soon be conducting studies to gain valuable insights into physiological changes when developing protocols for depression and PTSD.
Measuring raw data via a wrist-worn device continues to see limitations in terms of feasibility, accuracy across diverse populations and ease of use. Biostrap Ethos aims to address those limitations with an all-encompassing digital health solution.
The timing of Biostrap's release comes at a time when the inclusion of diverse populations and a need for accurate remote monitoring solutions are gaining momentum. Utilizing a proprietary novel sensor technology, Ethos will be able to deliver continuous medical-grade SpO2 data for the full range of skin pigmentation.
Additional measurements include heart rate, heart rate variability, arterial properties, respiratory rate, skin temperature, activity tracking, comprehensive analysis of sleep quality and more.
The new device will only be available for health care professionals, pilot studies and research purposes starting Q1 2023.