Sibel Health’s Anne Chest and Limb sensors can now be used with a variety of software platforms.


RT’s Three Key Takeaways:

  1. Expanded Compatibility: The Anne Chest and Anne Limb wearable sensors have received additional FDA clearances, allowing them to operate with compatible third-party software applications.
  2. Versatile Monitoring: These wearable sensors are cleared to monitor vital signs for patients aged 12 and up, both in home and hospital environments.
  3. Enhanced Integration: Sibel Health’s latest FDA clearances allow for greater integration of their sensors with external software.

Sibel Health announced it has received two additional US Food and Drug Administration (FDA)-clearances enabling its Anne Chest and Anne Limb wearable sensors to operate with compatible third-party software applications. 

The flexible wearables are rechargeable, reusable, and cleanable, allowing them to be deployed across a range of clinical use cases, from clinical trials to in-facility hospital monitoring.

With the clearances, the sensors are now compatible with third-party software applications that integrate with Sibel’s software development kit (SDK). 

The Anne Chest sensor is FDA-cleared for a 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

“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 one 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 a release. 

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.

Photo caption: Anne Chest and Anne Limb sensors

Photo credit: Sibel Health