The new device marks the digital biomarker platform's pivot to serve the health care industry and improve patient care emphasizing inclusion and accuracy along with a FDA 510(k) Class II clearance submission scheduled for Q1 2023
LAS VEGAS, Nov. 10, 2022 /PRNewswire/ -- Biostrap, a high-resolution biosensor-based digital biomarker platform pioneering the space of clinically reliable biosensors, data processing techniques and remote physiological monitoring, is soon to be releasing Ethos, a groundbreaking wearable technology to unlock the power of 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.
The company will be exhibiting at HLTH in Las Vegas, health care's number one innovation event (November 13-16), to demo the new device during one-on-one meetings.
"Our R&D and science teams have been working for over two years to develop this technology," says Sameer Sontakey, Biostrap CEO and Co-Founder. "Attending HLTH with Ethos in hand, we are looking forward to connecting with decision-makers, investors and health care professionals as we aim to bridge the technology gap between clinical research and clinical care."
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.
To schedule an in-person meeting at HLTH, please email pr@biostrap.com or visit us at our Booth 2858 - kiosk 6.
Biostrap is a high-resolution, biosensor-based digital biomarker platform that is pioneering the space of clinically reliable biosensors, data processing techniques and remote physiological monitoring. Biostrap's novel wearable, remote patient monitoring platform solves the challenges commonly encountered in the clinical space by providing objective 24/7 medical-grade measurements of physiological and behavioral data from the comfort and convenience of a patient's home.
SOURCE Biostrap
