Technical Specifications& FAQ

• Wear Location: Anterior or posterior placement depending on the location of interest.
• Battery Life: 24+ Hours
• Dimensions: 3.3” x 2” x .39”
• Weight: 100g
• Water Resistant
• 6 axis accelerometer
• Multi-Channel MEMS microphone array
• Communication: Bluetooth Low Energy
• Noise Cancellation
• FDA 510(k) Class II Medical Device
• CE Mark Class I Device

• Cough
• Wheeze
• Rhonchi
• Crackles
• Respiratory Rate*
• Heart Rate*
• Body Positioning*
• Sleep/Wake*
• Activity Levels*

*Measurement not FDA cleared

• HIPAA Compliant
• Data at rest encrypted
• Data in transit encrypted
• PHI safeguards
• Noise cancellation

The RESP Biosensor is a remote monitoring wearable device intended for demonstrating treatment efficacy in clinical trials as well as remote patient monitoring of at-risk cardiopulmonary patients.

The RESP® Biosensor sits on the patient’s chest wall and passively records  patient’s lung sounds including cough, wheeze and crackles. The device also collects motion data to capture respiratory rate*, heart rate*, activity levels*, and body positioning*.

*Measurement not FDA-cleared

The non-invasive RESP® Biosensor is placed over the skin and adhered via Tegaderm–acrylic based adhesive. Patients often forget the device is on when wearing and can go on with their daily routines.

The RESP Biosensor has received two FDA 510(k) clearances to record lung sounds. In order to receive FDA clearance,  Strados Labs provided test results that demonstrated audio performance that is substantially equivalent to commercially available  electronic stethoscopes.

Lung sound recordings captured by the RESP® Biosensor are transferred via Bluetooth to a companion patient mobile app, and from there is sent to the Strados cloud via Wi-Fi or cellular data.

We have developed a validated overread process that includes our team of respiratory therapists and specialists who manually review lung sound recordings to meet regulatory and clinical requirements for data accuracy.

Our machine learning algorithms have also been trained based on clinically validated labeled data and performance tested to meet customer requirements. Algorithms can be used independently for event detection or to feed data to our validated overread process.

The RESP® Biosensor is often worn for 24-hour periods in clinical trials and has roughly a 25-hour battery life. However, patients can wear the device anywhere from 7 days to 30 days. Patients are given two devices and if they’re instructed to wear the device on consecutive days; they will need to replace the device with a fully charged one after the battery runs out every 24 hours.

The RESP® Biosensor is reimbursable under RPM and RTM codes.

The device is typically placed on the front or left side of the chest but can also be placed on the back depending on the use case. 

The RESP® Biosensor is similar to a wearable digital stethoscope and records patient lung sounds with an inward-facing microphone. The device also contains an accelerometer to capture motion data, which allows the device to collect respiratory rate, heart rate, activity levels and body positioning. The device is currently FDA-cleared to collect lung sounds– all motion data is for clinical trial use only. 

Yes. The RESP® Biosensor was designed for long-term, continuous remote monitoring with the goal of detecting changes in lung sounds passively ranging from 4 – 24 hours per day.  

The RESP® Biosensor is reusable and rechargeable; each device can be used with multiple patients after cleaning and sanitizing it. The device has a shelf-life of three years. 

The RESP® Biosensor is designed to be used across multiple care settings, including clinical trials,  in-patient, transitional care, post-acute discharge, outpatient, and hospital at home. 

The RESP® Biosensor has been used in healthcare settings (hospital and outpatient) and in drug development within phase I and phase II clinical trials.

While the device has an inward-facing microphone, it on occasion can capture patient conversations. However, due to noise filtering and other processes including speech scrambling, patient conversations are not heard by our overread team or clinicians.

The RESP Biosensor  is HIPAA compliant. All sensitive patient data is encrypted when stored and transferred between the RESP Biosensor and Strados Mobile App. Patient data can only be accessed and played back from within the app or the Strados Clinician Portal. Furthermore, the Mobile App is designed so that no patient data is user-accessible on the mobile device. Finally, only users with validated accounts and passwords can access recordings.

Yes. The RESP® Biosensor is available for purchase globally for clinical trials and in the US only for healthcare use cases.

Pricing of the RESP® Biosensor varies depending on the use case, number of devices deployed, and other factors. Please contact our team if you are interested in learning more about pricing.  

The RESP Biosensor is compatible with Android mobile devices running the Android v5.0 and higher operating systems. It is also compatible with iOS devices.

The RESP Biosensor synchronizes recorded patient data to a mobile device over Bluetooth. Ensure that your mobile device is Bluetooth enabled with v4.1 or higher, and that this functionality is enabled before attempting to use the biosensor.

A new user can easily create a new account by selecting “Create” on the login screen. The app will guide you through the account creation process, and then ask you to verify the account through your email.

A user can quickly set up a patient record by tapping the pencil icon next to the patient name on the dashboard screen. The Strados Mobile App will present a list of patients, and an ADD NEW PATIENT button. Select that button and the app will guide you through the rest of the process.

The RESP Biosensor is designed for easy setup and use. First, simply un-package the system, and set up the Strados Charging Station on a flat surface at least 1.5m from the patient.  Connect the wall adapter to the charging station and connect it to a wall outlet. Next, place the biosensor into the wireless charging bins.

While charging, download and install the Strados Mobile App from the Google Play store on an Android mobile device. Once the charging station indicates that the biosensor is charged, remove it, and press the button to power it on. Pair the biosensor with the mobile device through the Strados app, then create a user account and a patient record.

Disinfect the biosensor then apply it to a patient using the provided patient adhesive or hold it against the patient by hand. The system is now ready to record. It is important to set up and use the system away from pets and small children. Please refer to the Instructions for Use or the Quick-Start guide for more detailed instructions and additional warnings and precautions before using the system.

The only way that the device is safely and effectively adhered to the patient is with the provided patient adhesive. No alternative methods should be attempted. To order additional adhesives, navigate to www.stradoslabs.com or contact us at info@stradoslabs.com.

To order additional patient adhesives, contact us at info@stradoslabs.com.