FDA Clears Biobeat’s Wearable Cuffless Blood Pressure Monitor

Biobeat, a medical technology company based in Tel Aviv, Israel, received 501K clearance from the U.S. Food and Drug Administration (FDA) for their wearable patch and smartwatch that can measure blood pressure. This is the first time that the FDA has approved a blood pressure monitor that does not utilize a cuff. Leveraging a discrete, wearable sensor and a compatible smartwatch, the Biobeat system provides continuous monitoring of important physiological data. Information provided by this system includes blood pressure, oxygenation, heart rate, and more.

“This is the first cuffless blood pressure solution to be cleared by the FDA—no more need for an inflating cuff,” said Arik Ben Ishay, Founder and CEO of Biobeat. “This clearance opens tremendous opportunities for remote monitoring of vital signs of patients and we are excited that we can now also offer this in the US market.”


The device can not only be used in hospitals and clinics but provides the patient with an opportunity to measure and monitor various vital signs at home as well. The Biobeat sensor is designed to be worn anywhere on the body and takes hundreds of samples every second. Broadcasting this physiological data online through the companion app, the Biobeat patch allows the physician to continuously monitor their patient. This patch is designed for single-use, working for up to 10 days. Using the device in a disposable manner eliminates the need for any recharging or disinfecting. The smartwatch can be worn for three consecutive days before needing to be recharged.

Features of the Biobeat Smartwatch and Sensor

  • Accelerometer (measures movement)
  • Bluetooth (connects sensors to devices that display data)
  • Recording memory
  • Photoplethysmography (determines heart rate and respiratory data through blood volume changes)
  • Galvanic skin response (determines emotional arousal through changes in the skin’s electrical activity)

In addition to these abilities, the wearable sensor can also conduct one-lead electrocardiography (ECG) when the patch is placed on the chest.

When the consumer uses Biobeat at home, they can pair the data to their smartphone so they can easily view all data being gathered by the sensor or watch in real-time. The device bolsters safety as well, being that the user can set threshold alerts to be notified when their vital signs are abnormal. In addition, they can share their data with physicians or loved ones as well so that emergencies can easily be identified.


Integrating this system into the hospital setting allows for multiple patients to be continuously monitored simultaneously. Biobeat claims that all in-patients of a hospital could be monitored at the same time on the system, freeing medical personnel from their duty of recording vitals.

“We truly believe our technology will change future patient care and monitoring, enabling individuals to have better control over their everyday life, in health and in sickness, as well as augmenting the capabilities of medical providers.” –Biobeat

About BioBeat

Biobeat was founded in 2016 and strives to create medical sensors that will improve the practice of both in-hospital and remote healthcare. The company’s products leverage cloud-based technologies to connect healthcare data between parties through the smartphone, tablet, and computer. Their devices emphasize non-invasive, wireless, and continuous monitoring of patients with various medical conditions.