Cuffless Blood Pressure Monitor Clinical Study Supports FDA Clearance for Aktiia
- Blog Team
- Jul 8
- 2 min read
Updated: Aug 15
Parameters Research Laboratory (PRL) is proud to have played a key role in the clinical study for a cuffless blood pressure monitor that recently received FDA clearance. The Hilo by Aktiia cuffless, wrist-worn blood pressure monitor is now approved for over-the-counter (OTC) use in the United States, marking a significant advancement in wearable cardiovascular technology.
A New Standard in Blood Pressure Monitoring
The Aktiia device provides non-invasive, cuffless blood pressure readings using optical sensors and proprietary algorithms. It allows users to monitor their blood pressure without the discomfort of traditional cuffs. The FDA’s clearance affirms that the device meets safety and accuracy requirements for OTC consumer use.
Our Role in the Clinical Study for This Cuffless BP Monitor
PRL led the multi-site clinical study that produced the key validation data for this breakthrough device. As a trusted research partner to medical device developers, we provided:
Full execution of a multi-site clinical trial across diverse U.S. populations
Overcoming complex participant recruitment challenges
Management of study operations and high-quality endpoint data
Adherence to Good Clinical Practice (GCP) standards throughout the trial
Our clinical team ensured accurate data collection under rigorous protocol conditions—laying the foundation for a successful FDA submission and eventual clearance.
What FDA Clearance Means for Device Developers
Aktiia’s clearance sets an important precedent for companies developing wearable and cuffless health technologies. Sponsors can now reference a proven pathway and a trusted partner for conducting a clinical study for cuffless blood pressure monitors or similar devices.
Benefits of this approval include:
Direct-to-consumer access without a prescription
Greater user adoption through comfort and ease of use
Opportunities to expand into remote patient monitoring and chronic condition management
Why Leading Device Sponsors Choose Us
Proven success in supporting FDA-cleared studies
Deep expertise in cardiovascular device validation
GCP-compliant clinical operations and regulatory alignment
A full-time, highly trained, on-site research team
Ready to Validate Your Device?
If you're developing a wearable, cuffless, or sensor-based medical device, trust Parameters Research Laboratory to deliver accurate, compliant clinical research. Our experience with complex multi-site trials and endpoint-focused studies makes us an ideal partner.
👉 Contact PRL today to learn more about how we can support your next clinical trial.
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