In a significant advancement for health technology, a pioneering company has achieved FDA 510(k) clearance for its innovative cuffless blood pressure monitoring device, known as the G0 Blood Pressure Monitoring System, or the Hilo Band. This breakthrough is set to revolutionize how individuals monitor their blood pressure, making it more accessible than ever.
The Hilo Band is a cutting-edge wearable device that utilizes advanced optical sensors to gather vital data directly from the wrist. This information is seamlessly transmitted to a dedicated app and a secure cloud server, where sophisticated algorithms analyze the data to provide accurate blood pressure readings through pulse wave analysis.
This unique analysis method focuses on the distinct pressure patterns generated by each heartbeat as it travels through the blood vessels, offering users a comprehensive view of their cardiovascular health.
Designed for continuous monitoring, the wristband collects blood pressure data throughout the day, but it only activates when the wearer is at rest, ensuring precise readings without interference from daily activities.
Having already received CE marking as a Class IIa medical device in Europe, this innovative product is expected to be available to consumers in the United States by 2026, marking a significant milestone in personal health technology.
According to Dr. Josep Solà, cofounder and chief technology officer, this achievement is not just a corporate milestone but a personal mission to combat the global hypertension crisis through innovative technology. He expressed optimism about the future, stating, “With this FDA clearance, we are one step closer to our vision of making healthy blood pressure accessible to everyone.”
Dr. Solà emphasized the importance of this moment, highlighting that the FDA’s approval for over-the-counter use without a prescription is a rare accomplishment, indicating that their technology is both clinically validated and ready for widespread use.
Dr. Mattia Bertschi, cofounder and CEO, noted that this FDA clearance opens new market opportunities while confirming the safety and user-friendliness of their solution. He believes that the future of blood pressure monitoring will increasingly rely on cuffless, wearable devices that are easily accessible to consumers.
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In recent months, the company has also secured substantial funding, raising $42 million in a Series B round, bringing its total funding to over $100 million. This financial backing will support further innovation and expansion in the health technology sector.
Last year, the company successfully completed a CHF 27 million ($30 million) funding round and received CE marking for its calibration-free technology, CALFREE, which allows for blood pressure data collection using optical sensors found in everyday devices like smartwatches and smartphones.
The approval of CALFREE technology is expected to facilitate partnerships with third-party companies, enabling the integration of medical-grade optical blood pressure monitoring into consumer devices, thus broadening the reach of this vital health technology.
Founded in 2018 as a spin-out from a Swiss research and development center, the company has quickly established itself as a leader in the field of continuous blood pressure monitoring, with a commitment to improving health outcomes for individuals worldwide.