CHICAGO, Aug. 22, 2024 /PRNewswire/ — Sibel Health has unveiled two significant FDA-clearances that pave the way for its cutting-edge wearable sensors to seamlessly integrate with third-party software solutions. In its mission to make vital signs monitoring universally accessible, Sibel Health is determined to democratize the use of its state-of-the-art wearables. The ANNE® Chest and ANNE® Limb sensors are now fully compatible with external software applications interconnected through Sibel’s software development kit (SDK). These innovative devices, designed to be flexible, skin-adaptive, rechargeable, and reusable, are perfect for a multitude of clinical settings—from rigorous clinical trials to routine hospital monitoring.
The ANNE® Chest sensor has received FDA clearance for a broad spectrum of physiological measurements for patients aged 12 and above, whether at home or in a hospital environment. This sensor provides essential data on ECG waveforms, heart rate, respiratory rate, physical activity, fall detection, body position, and skin temperature.
Similarly, the ANNE® Limb sensor has been FDA-cleared for additional physiological metrics for the same age group in both home and clinical settings, focusing on measurements such as SpO2, pulse rate, and skin temperature.
Sibel Health’s commitment to serving low-resource areas is exemplified by a significant grant recently awarded by the Bill & Melinda Gates Foundation to enhance maternal health monitoring. Sibel takes immense pride in ensuring that its pulse oximeter provides accurate readings across a diverse range of skin tones, showcasing their dedication to inclusivity in healthcare.
Steve Xu MD, CEO and co-founder of Sibel Health, acknowledged the swift integration of their wearables and SDK by strategic partners—from pharmaceutical giants to leading medical technology companies—who have rapidly developed innovative software applications, some in as little as one week. “We recognize that we cannot create software for every specific application, and thanks to these FDA-clearances, we don’t need to. Our goal is to empower other innovators with continuous vital signs data from our FDA-cleared sensors, wherever there’s a clinical need,” remarked Dr. Xu. This announcement follows Sibel’s earlier FDA-clearance in August 2023 for its comprehensive monitoring system, which includes both the ANNE® Chest and Limb sensors for ongoing vital signs assessment.
To propel its commercial growth, Sibel Health has appointed the highly esteemed Bill Nelson as its first Chief Revenue Officer. With over 30 years of experience in commercial medical technology roles at companies like BioIntellisense, Joerns Healthcare, and Stryker, Bill Nelson is thrilled to join Sibel Health. “I have never encountered a technology with such vast applications and clinical use cases across the healthcare sector. These recent FDA clearances will only accelerate our progress,” expressed Nelson.
Dr. Xu added, “We are enthusiastically inviting organizations to collaborate and integrate our advanced sensors with emerging digital health software applications.”
About Sibel Health
Sibel Health is an award-winning health technology firm dedicated to providing Better Health Data for All®. Headquartered in Chicago with an international office in Seoul, Sibel’s FDA-cleared ANNE® platform features advanced wearable sensors, AI-driven data analytics, and a comprehensive mobile software and cloud system. The company collaborates with some of the world’s most respected healthcare organizations. For more information, visit www.sibelhealth.com and follow the latest updates on LinkedIn.
Contact: contact@sibelhealth.com
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SOURCE Sibel Health