Two New FDA-Clearances for Sibel Health Enables Compatibility of Advanced Wearable Sensors to 3rd Party Software Solutions
CHICAGO, Aug. 22, 2024 /PRNewswire/ — Sibel Health announces two additional FDA-clearances enabling its advanced wearable sensors to operate with compatible third party software applications. In order to democratize vital signs globally, Sibel Health is committed to enabling widespread access to its advanced wearable sensors. The ANNE® Chest and ANNE® Limb wearable sensors are now compatible with third party software applications that integrate with Sibel’s software development kit (SDK). These flexible and skin-conformable wearables are rechargeable, reusable, and cleanable allowing them to be deployed across a wide range of clinical use cases from clinical trials to in facility hospital monitoring.
The ANNE® Chest sensor is FDA-cleared for a wide range of physiological parameters for patients 12 years and up in the home or hospital setting.
- ECG waveforms
- Heart rate
- Respiratory rate
- Activity
- Fall detection
- Body position
- Skin temperature
Similarly, the ANNE® Limb sensor is FDA-cleared for additional physiological parameters for patients 12 years and up in the home or hospital setting.
- SpO2
- Pulse rate
- Skin temperature
As a company committed to operating in low resource settings, evidenced by a recent major grant from the Bill & Melinda Gates Foundation for maternal health monitoring, Sibel is proud of its work in validating the accuracy of its pulse oximeter across a wide range of skin tones.
“Our strategic partners from pharmaceutical companies to major medical technology companies are already spinning out amazing software applications leveraging our wearables and SDK in as little as 1 week. We know we can’t make software for every application—and with these FDA-clearances we won’t have to. We want to enable other creators to have access to continuous vital signs from our FDA-cleared sensors wherever they see a clinical need,” says Steve Xu MD, CEO and co-founder of Sibel Health. In August 2023, Sibel announced FDA-clearance for its complete monitoring system that includes both the ANNE® Chest and Limb sensors for continuous vital signs assessments.
To accelerate its commercial growth, Sibel Health has also brought in a deeply respected and experienced commercial leader in Bill Nelson as Sibel’s first Chief Revenue Officer. Bill brings more than 30 years’ experience in commercial medical technology roles including BioIntellisense, Joerns Healthcare, and Stryker. Bill Nelson notes, “I am genuinely excited to join Sibel Health at this incredible inflection point. Never before in my career have I seen a technology with so many applications and use cases across healthcare—these two most recent FDA clearances further enables this acceleration.”
“We’re excited to let organizations know that we’re open to collaborate and integrate our sensors with new digital health software applications,” says Steve Xu MD.
About Sibel Health
Sibel Health is an award-winning health technology company with a mission to deliver Better Health Data for All®. Based in Chicago with an international office in Seoul, the company’s FDA-cleared ANNE® platform includes advanced wearable sensors, AI-enabled data analytics, and an integrated mobile software and cloud platform. Sibel has partnerships with some of the most respected healthcare organizations worldwide. For more information, please visit us at www.sibelhealth.com and follow us on LinkedIn.
Contact: contact@sibelhealth.com
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SOURCE Sibel Health
