Biobeat Technologies’ BB-613WP was approved for the continuous measurement of blood pressure, blood oxygen saturation and heart rate in adult patients at home and in hospital settings.
Classified as Class II medical device, the unit is commonly known as Oximeter.
Regulatory approvals for BB-613WP blood pressure monitoring device
Biobeat Technologies submitted a pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for approval of the device in March 2019, securing FDA clearance in August 2019. The device is also approved in Israel and holds the EU’s CE Mark.
The wearable remote monitoring device received additional clearance to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate from the FDA in March 2022.
Biobeat’s wireless wrist and chest monitoring devices became the first to be cleared by the FDA for cuffless blood pressure monitoring from photoplethysmography (PPG) only, which can support healthcare professionals by transmitting patient data in real-time.
The US Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research, Innovation, and Ventures (DRIVe) provided around $600,000 for developing the technology in December 2018.
The Biobeat project was a part of the Early Notification to Act Control and Treat (ENACT) portfolio to empower patients with early health warnings in a minimally invasive manner.
The project was developed at about $954,800, with DRIVe contributing $599,000, and Biobeat provided the remaining funds for development.
BB-613WP blood pressure monitoring device design and features
BB-613WP system is available in two versions, a wrist-worn watch version and an adhesive patch version. It contains a LED and an array of sensors behind the device. Light is transmitted from the LED to the patient’s skin, sensed by a photodiode following partial reflection from the tissue.
The photodiode window of the watch is made of polycarbonate, while the adhesive patch is made of silicone. The peak wavelength of emitted light lies at 880nm (IR) and 650nm (Red).
Integrated results of the patient’s blood pressure, pulse rate and oxygenation are displayed on the LCD screen of the watch and the user’s mobile application and Biobeat app for the patch. The device does not store data but transmits it to the hand-held device using Bluetooth. The battery life of the watch is up to three days, while that of the patch is up to eight days.
The BP measurement range of the device is between 0mmHg and 299mmHg with ±5mmHg accuracy. The device measures heart rate between 40bpm and 250bpm. The oxygen saturation measurement rate is 40% to 99%.
Technology used in the BB-613WP BP monitoring device
BB-613WP system comes from Biobeat’s patented, proprietary reflective PPG sensor. PPG sensor allows the device to read PPG signal wave, crucial in measuring various complex physical parameters.
The device tracks blood pressure changes on Pulse Wave Transit Time (PWTT) principle.
Benefits of BB-613WP BP monitoring device
Unlike the traditional wired blood pressure monitoring device, Biobeat’s cuffless BP monitoring device can be used for short and long-term monitoring of patient vitals.
The single-patient, disposable patch can be used in hospitals for emergency services for short-term patient monitoring without risk of disease transmission. A separate sticker and sensor capsule facilitate easy removal and replacement of the device. The patch can be used for the automatic generation of patient reports such as Medical Sleep Lab and a Blood Pressure Holter, transferred to the healthcare professionals via the Biobeat Cloud.
The wearable wrist device serves as an ideal solution for long-term remote monitoring of patients in nursing homes and through telemedicine.
Clinical studies on the BB-613WP BP monitoring device
Biobeat performed a clinical study on the BB-613WP device in collaboration with The Baruch Padeh Medical Center in Poriya, enrolling 30 patients undergoing cardiac surgery to compare its BP measurements with the predicate devices.
The device was found to be significantly safe and equivalent to its predicate devices BB-613 (K181006) and Mini-Medic (K113165) and has been clinically validated for blood pressure as per ISO 80601-2:2013 standards.
Marketing commentary on Biobeat
Biobeat is a medical technology company based in Israel, which focuses on the development of medical-grade wireless technology products. It is a revenue-stage company with 15 employees and has started commercialisation in Israel and Europe. It is a mid-tech company with a unique health-AI platform that includes a disposable short-term chest monitor and a long-term wrist monitor.
Biobeat is now a part of ‘TGH at Home’, an innovative program started by Tampa General Hospital, in which patients can get treated from the comfort of their home. Using Biobeat’s platform, the “TGH at Home” care team of doctors and nurses stays in close contact with each patient to monitor their condition and make any treatment changes needed for optimum recovery.
With its wireless chest monitors, Biobeat will provide Remote Patient Monitoring (RPM) for the patients in the programme, enabling expert care and innovative technology, focusing on the patient’s needs.
The company’s wearable devices are now being sold in more than 20 countries, including US, Germany, France, Belgium and Italy, and are used by hospitals and pharma companies to treat. their patients.