Is Hilo Core FDA-Cleared? The Evidence Behind the System
Blood pressure varies throughout the day and can change with sleep, physical activity, posture, stress, meals, and measurement conditions. A cuff captures a defined moment. The band and app extend the view across days and weeks, giving users a way to explore what may be happening around those moments. Read the 2025 AHA/ACC High Blood Pressure Guideline.
Explore Hilo Core or see how the cuff, band, and app work together.
Key Facts
- Regulatory status: Hilo Core is a general wellness product in the United States — not FDA-cleared as a medical device, and intentionally designed within FDA's General Wellness guidance framework.
- Validated cuff included: The upper-arm cuff shipped with Hilo Core was validated in a peer-reviewed study using the ANSI/AAMI/ISO 81060-2:2013 protocol and met both prespecified acceptance criteria.
- FDA milestone: In July 2025, the FDA cleared the Aktiia G0 Blood Pressure Monitoring System — built by the same team — as the first over-the-counter cuffless blood pressure device cleared in the United States.
- Two layers, one system: The cuff measures; the band and app add context — each type of information is shown separately and serves a distinct purpose.
In 2025, the Hilo Team Achieved an FDA Milestone
In July 2025, the FDA cleared the Aktiia G0 Blood Pressure Monitoring System — the technology behind Hilo — as a Class II device for over-the-counter spot-check use within its labeled population and conditions. View the FDA 510(k) record for K250415 and read the FDA 510(k) summary.
MedTech Dive described the clearance as the first FDA clearance for an over-the-counter cuffless blood pressure device in the United States. Read the independent report. For Hilo Core users, the relevance is the team behind it: the people bringing Hilo Core to the U.S. have already taken blood pressure technology through clinical, engineering, quality, and regulatory review.
Hilo Core itself is offered as a general wellness product — a deliberate regulatory approach that keeps the product's claims within FDA's wellness guidance framework.
What Is Hilo Core's FDA Status?
In the United States, Hilo Core is a general wellness product and whilst following the FDA wellness guidance is not FDA-cleared as a medical product. FDA's January 2026 General Wellness: Policy for Low Risk Devices describes when low-risk, noninvasive products may present physiological values, ranges, baselines, trends, and longitudinal summaries for general wellness use. The guidance includes an example of a wrist-worn wearable that outputs blood pressure with other biomarkers, provided the blood pressure values have been validated and the claims remain in a wellness setting. Read FDA's General Wellness guidance.
The FDA's guidance also sets limits. Labeling and functionality should stay outside diagnosis, disease screening or monitoring, clinical thresholds, treatment recommendations, and substitution for an FDA-authorized medical device. Following this policy does not give an individual product FDA clearance or approval. Read the FDA guidance PDF.
Hilo Core is offered within that framework, with distinct roles for the cuff and the cuffless experience. The upper-arm cuff supplies a point-in-time reference reading. The band and app present longer-term information for general wellness use, with each type of information shown separately.
Hilo Core is designed to support awareness and understanding of blood pressure patterns within the general wellness framing described in current FDA guidance. The band supports awareness and context; the cuff remains the reference measurement.
The Included Upper-Arm Cuff Has Published Validation Evidence
The upper-arm cuff included with Hilo Core was evaluated in a peer-reviewed study published under its earlier Aktiia name. In 2023, three trained observers compared readings from the cuff with reference double-auscultation measurements in 85 adults, using the ANSI/AAMI/ISO 81060-2:2013 protocol. Read the cuff validation study.
Compared with the reference method, the mean difference was 1.3 mm Hg for systolic pressure and -0.2 mm Hg for diastolic pressure. The corresponding standard deviations were 7.11 and 5.46 mm Hg. The cuff met both prespecified acceptance criteria.
Those results support a specific claim about the cuff's point-in-time measurements. They do not establish clinical validation for every component or function in Hilo Core. A validation result applies to the device, method, population, and use evaluated in the study.
The 2018 AAMI/ESH/ISO collaboration statement set out a universal standard intended to harmonize the evaluation of blood pressure devices internationally. Read the AAMI/ESH/ISO Universal Standard statement.
The 2025 AHA/ACC High Blood Pressure Guideline recommends validated oscillometric devices, an appropriately sized cuff, standardized preparation and positioning, and repeated measurements. A single result can misrepresent a person's usual blood pressure, even when the device itself has been validated. Review the guideline's blood pressure measurement recommendations.
Why an Included Reference Cuff Matters
Hilo includes the cuff used for its reference readings, so users do not need to buy a separate device for setup. The same app guides the cuff workflow and displays the resulting readings in a dedicated view. Setup, instructions, and data flow remain within one system.
Published research shows why the validation status of a separately purchased device should not be assumed. A 2023 JAMA analysis followed the 100 best-selling blood pressure device lists on Amazon in 10 countries over one year. Across those countries, the median proportion classified as nonvalidated was 79% for upper-arm devices and 84% for wrist-cuff devices. Read the 2023 JAMA analysis.
A separate 2022 JAMA analysis of 3,411 automated devices marketed globally found published validation evidence, including validated or equivalent status, for 19.9%. For 76.3% of devices, the researchers found no published validation evidence. Read the 2022 JAMA analysis.
Neither analysis directly tested the accuracy of every model. In the 2023 study, a device was classified as non-validated when it did not appear on the validation lists used by the researchers. That status is different from a failed accuracy test. A usable reference reading also depends on the right cuff size and correct technique.
Providing the validated cuff with Hilo removes one purchasing decision and gives users one set of instructions for setup and reference readings.
How the Cuff and the Cuffless Wrist Band Divide the Work
Use the validated upper-arm cuff when you want a defined blood pressure reading at a particular time. The cuffless band and app add a longer view across days and weeks, so users can notice whether changes appear alongside sleep, movement, stress, or changes in routine. The app is centered on blood pressure, with no composite readiness or performance score.
The 2025 AHA/ACC guideline states that cuffless blood pressure devices should not be used for the diagnosis or management of high blood pressure. Read the guideline section on cuffless blood pressure devices.
The American Heart Association's scientific statement explains that cuffless systems estimate blood pressure indirectly, often using photoplethysmography and calibration. Motion, sensor position, body posture, and hydrostatic pressure can affect performance during everyday use. Read the AHA scientific statement on cuffless blood pressure devices.
In Hilo Core, the cuff supplies the point-in-time reference reading. The cuffless record is intended for longer-term observation within the general wellness framework. Users can review that record and, when useful, share it with a healthcare professional. Clinical decisions require appropriate medical measurements and professional judgment.
Medical-Device Research Is Our Foundation
The research behind Hilo began in 2004 at the Swiss Centre for Electronics and Microtechnology, where scientists explored whether optical signals at the wrist could be used to estimate blood pressure without repeated cuff inflation. Work over the following years examined optical sensing, pulse-wave analysis, calibration, and the conditions required to obtain usable signals outside a laboratory. Read the Hilo story.
A separate European product, the Hilo Bracelet G1, has been clinically evaluated and CE-marked as a Class IIa medical device under the EU Medical Device Regulation. That status and supporting evidence apply to the Hilo Bracelet G1, not to Hilo Core as sold in the United States.
Hilo Core draws on the same organization's experience in optical sensing, pulse-wave analysis, calibration, clinical research, and regulated product development.
What Using Hilo Core Looks Like Day to Day
A reference reading starts with the included upper-arm cuff. The band can then be worn through ordinary routines, and the app provides a longer view once enough information has accumulated. Users can review changes over time and note possible associations with sleep, activity, stress, or schedule.
The product stays focused on blood pressure. Cuff readings retain their identity as cuff readings, while cuffless information appears as a longitudinal record. One app keeps the setup, reference readings, and day-to-day record in a consistent workflow.
Read why blood pressure changes throughout the day and explore the science behind Hilo Core.
An Integrated System with Defined Roles
Hilo brings the cuff, band, and app into one guided experience. The included cuff supplies a validated point-in-time reference reading. The cuffless experience adds a longer record of day-to-day patterns, and the app keeps each type of information in its assigned role. This is good measurement design: use the validated cuff for a reference; use the cuffless wrist band and the app for context.
For people who want to pay closer attention to blood pressure without adopting another broad performance score, that structure offers a practical place to start. Explore Hilo Core and learn how the system works.
When a Very High Reading Needs Urgent Action
If your blood pressure is higher than 180 systolic and/or 120 diastolic, wait at least one minute and measure again.
If the second reading is just as high and you have chest pain, shortness of breath, back pain, numbness, weakness, a change in vision, difficulty speaking, or another new concerning symptom, call 911.
If you do not have symptoms but the reading remains that high, contact your health care professional promptly.
Follow the American Heart Association severe-hypertension guidance.
Do not change medication based on a single reading unless a qualified clinician tells you to.
For everyday use outside of emergency situations, the following applies to all Hilo Core features and information.
Important Information
Hilo Core is a general wellness product. It is not intended to diagnose, cure, mitigate, treat, or prevent any disease or medical condition. Hilo Core is not intended to measure blood pressure for medical purposes. Cuffless wellness information should not be used to change medication or as a substitute for validated cuff-based measurements, professional medical advice, diagnosis, treatment, or emergency care.
Frequently Asked Questions
Is Hilo Core FDA-cleared?
Is Hilo FDA approved?
Does the cuff in Hilo Core meet clinical standards?
Can I use Hilo Core instead of a doctor-prescribed blood pressure device?
What is the difference between the Hilo Core cuff and the wrist band?
Sources
- U.S. Food and Drug Administration. General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff. Issued January 6, 2026. Accessed July 15, 2026. FDA guidance.
- Jones DW, Ferdinand KC, Taler SJ, et al. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. Circulation. 2025;152:e114-e218. doi:10.1161/CIR.0000000000001356. AHA journal record.
- Cohen JB, Byfield RL, Hardy ST, et al. Cuffless Devices for the Measurement of Blood Pressure: A Scientific Statement From the American Heart Association. Hypertension. Published online December 11, 2025. doi:10.1161/HYP.0000000000000254. AHA scientific statement.
- Alexandre J, Tan K, Almeida TP, Sola J, Alpert BS, Shah J. Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol. Blood Press Monit. 2023;28(2):109-112. doi:10.1097/MBP.0000000000000639. PubMed record.
- Stergiou GS, Alpert B, Mieke S, et al. A Universal Standard for the Validation of Blood Pressure Measuring Devices: AAMI/ESH/ISO Collaboration Statement. Hypertension. 2018;71(3):368-374. doi:10.1161/HYPERTENSIONAHA.117.10237. AHA journal record.
- Picone DS, Chapman N, Schultz MG, et al. Availability, Cost, and Consumer Ratings of Popular Nonvalidated vs Validated Blood Pressure-Measuring Devices Sold Online in 10 Countries. JAMA. 2023;329(17):1514-1516. doi:10.1001/jama.2023.2661. JAMA article.
- Picone DS, Campbell NRC, Schutte AE, et al. Validation Status of Blood Pressure Measuring Devices Sold Globally. JAMA. 2022;327(7):680-681. doi:10.1001/jama.2021.24464. JAMA article.
- U.S. Food and Drug Administration. 510(k) Premarket Notification K250415: G0 Blood Pressure Monitoring System. Decision date July 2, 2025. Accessed July 15, 2026. FDA database record; FDA 510(k) summary.
- Hilo. About Hilo and official European product information for the Hilo Bracelet G1. Accessed July 15, 2026. Hilo company history; European product information.
- American Heart Association. Home Blood Pressure Monitoring. Accessed July 15, 2026. AHA guidance.
- American Heart Association. When to Call 911 About High Blood Pressure. Accessed July 15, 2026. AHA emergency guidance.
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