Cuffless Blood Pressure Devices Get FDA Approval, Redefining Home Health Monitoring
Modern healthcare is stepping into a new era as cuffless blood pressure devices gain FDA approval. These wearables promise comfort, accuracy, and convenience. However, traditional monitors still play an essential role in managing hypertension.
The FDA recently cleared the first over-the-counter cuffless blood pressure device, the Hilo Band (G0 Blood Pressure Monitoring System). This marks a major milestone for wearable health technology. With hypertension affecting over 1.3 billion people globally, easier access to frequent monitoring could help improve health outcomes. The Hilo Band is not a complete replacement yet, but it signals progress toward continuous, user-friendly tracking.
How the Hilo Band Works
The Hilo Band uses photoplethysmography (PPG), a light-based sensor that detects blood flow in the wrist. It can record up to 50 readings a day, working seamlessly day and night. In July 2025, the FDA granted 510(k) clearance for its over-the-counter sale to adults in the U.S. Clinical trials confirmed its accuracy, meeting ISO 81060-2 standards. Expected to launch in 2026 at around $280, it requires monthly calibration with a traditional cuff for precise readings.
Innovations and Challenges
Beyond wristbands, scientists are developing other cuffless tools, such as rings, smart glasses, and chest patches. These rely on advanced algorithms and optical signals to measure blood pressure. However, experts caution that accuracy under different conditions still needs improvement. Regulators are now creating uniform standards to ensure safety and reliability.
For users, the new cuffless options could make daily monitoring easier. For clinicians, they offer valuable long-term data. Still, experts recommend confirming readings with traditional cuffs before making medical decisions.
