The Week in Blood Pressure & Wearables — October 2-8, 2026
By Yair Lurie, Founder and CEO, Cardiowell. Published October 9, 2026.
On October 5, Happy Health announced that FDA cleared its ring to measure blood pressure with no cuff and no calibration. It's a wearable that people put on and leave on, and it needs no cuff to set it up. That's this week's deep dive.
Also this week: Sky Labs started a UK study to get its cuffless ring listed for 24-hour monitoring, Oura said it finished a large blood pressure study, Teladoc added camera-based vital signs to virtual visits, and a meta-analysis of 27 trials backed intensive blood pressure targets with or without kidney disease.
Deep dive: Happy Health's ring is FDA cleared for cuffless, calibration-free blood pressure
What FDA cleared
FDA cleared the Happy Health Blood Pressure Monitor on September 3, 2026, under 510(k) number K254000, per the FDA database. It's a Class II device under product code DXN, the same code used for noninvasive blood pressure monitors such as home cuffs. The company announced it on October 5 in a press release.
The cleared product is software. According to the FDA 510(k) summary, it reads signals from Happy's own FDA-cleared ring, worn on the index finger: an optical pulse sensor (PPG), skin conductance, motion, and skin temperature. A cloud-based model calculates systolic and diastolic pressure from those signals. The summary describes the model as biophysics-based, with no machine learning.
There's no cuff calibration. Each reading stands on its own, with no starting value from a cuff.
Who the label covers
The clearance is for spot-check readings at home or in a clinic, in adults 22 to 50. The device is for measurement and display only, and it makes no diagnosis.
The FDA summary excludes atrial fibrillation (AFib) and other arrhythmias, pregnancy, severe vascular disease, people "under vasoactive drugs," and readings taken during motion or with low blood flow to the finger. The summary doesn't define "vasoactive drugs."
How it was tested
Happy validated the device against an arterial line, a catheter placed in an artery, in 85 people and 850 readings. Mean error was 0.81 mmHg systolic and 0.12 mmHg diastolic. The standard deviation was 6.09 mmHg systolic and 3.16 mmHg diastolic, inside the ISO 81060-2 limit of 8 mmHg.
The mean error tells you the readings average out close to the reference across the group. The standard deviation tells you how far any one reading can stray. A spread of about 6 mmHg systolic means some individual readings will be off by 10 mmHg or more. That's true of every blood pressure device, and it's why treatment decisions should rest on averages of several readings.
FDA's January 2026 draft guidance on cuffless devices recommends testing spot-check devices against manual cuff readings by a trained observer. Happy's filing came before that draft was issued. The guidance is a draft and not yet in effect.
Why the clearance matters
Happy's predicate, the device it was compared with for the 510(k), is Aktiia's G0. Happy's own filing describes G0 as needing a cuff calibration every 24 hours. Happy's ring needs none. That's real progress, and it removes one of the steps that makes cuffless devices hard to use at home.
Happy calls itself the first company cleared for cuffless, calibration-free blood pressure. Biozen's BP1000 also needs no cuff calibration and was cleared in May, MassDevice reported, but the user presses a fingertip on its sensor to take each reading. Happy's ring is the first of the two that's worn passively. Its CEO calls the clearance "blood pressure's CGM moment."
What to watch
Today, people get the ring through Happy Sleep, a sleep apnea testing program. A physician prescribes a home sleep test, and nightly blood pressure comes with it. The program's terms set no upper age limit, per Happy Sleep. After the test, patients keep the ring, and tracking after the first year requires a paid membership, per the Happy Sleep user agreement.
So people over 50 could wear the ring and see a blood pressure number outside the cleared age range. About 72% of US adults 60 and older have hypertension, per CDC data.
The app also shows an average overnight blood pressure. The FDA summary describes spot-checks and doesn't mention sleep. Finger pressure changes roughly 0.8 mmHg for every centimeter the hand moves above or below the heart, and during sleep the hand can be anywhere.
I'd ask Happy Health whether the app limits blood pressure display for users over 50 or with AFib. I didn't find an answer in its public materials.
My view as a founder who works with FDA-cleared blood pressure devices
Cardiowell's blood pressure monitor is FDA 510(k) cleared. In general, a 510(k) requires a manufacturer to show the FDA that its device is substantially equivalent to one already legally on the market. For a blood pressure monitor, that typically means clinical validation against a reference under a recognized standard, and a label limited to what the evidence supports. That label is what lets a clinician use the number to diagnose and adjust medication. Cardiowell's latest device is indicated for ages 3 years and older, pregnancy, and diabetes.
Happy's label is narrow because its evidence covers a specific group. That's how the process is supposed to work. The question for clinics is what happens when the device reaches people outside that group.
Hypertension is most common after 50, most people being treated take at least one blood pressure medication, and AFib becomes more common with age. A ring cleared for adults 22 to 50 doesn't cover many of the people in the hypertension programs we support. A validated upper-arm cuff, used on a regular home schedule, does.
The cuff is improving too. This week, Jichi Medical University and Omron published a study in Hypertension Research of a new low-pressure, faster inflation method on an upper-arm cuff. Peak cuff pressure dropped by 32 to 51 mmHg, measurements were 7 to 15 seconds shorter, and people rated the cuff as less tight. Omron funded the study, and the abstract doesn't report accuracy against a reference. Still, a cuff people don't mind wearing gets used more often.
I'm optimistic about where this is heading. A calibration-free ring with an FDA clearance didn't exist a year ago. I hope the next filings cover adults over 50, people on blood pressure medications, and nighttime readings. When they do, we'd want those readings in Cardiowell's Hypertension OS, next to the home cuff readings clinics already trust.
Devices & Wearables
Sky Labs starts a UK study to list its cuffless ring for 24-hour monitoring
Sky Labs began a UK validation study of its CART BP pro ring, Korea Biomedical Review reports. Participants wear the ring and a standard cuff-based ambulatory blood pressure monitor (ABPM) at the same time for 24 hours, and researchers compare daytime, nighttime and overall readings. Sky Labs says the design follows NICE guidance and NHS practice.
The goal is a listing on the British and Irish Hypertension Society's validated device register. It would be the first cuffless device listed there for 24-hour ABPM, according to the article. Sky Labs plans to finish by the end of 2026 and hasn't disclosed sites or sample size.
CART BP pro is a finger ring that uses an optical (PPG) sensor, per Korea Biomedical Review, and is calibrated with a cuff. It's approved and reimbursed in Korea under the 24-hour ABPM code, holds CE marking under the EU Medical Device Regulation and UK MHRA registration, and isn't FDA authorized. Sky Labs plans a De Novo submission and is targeting US authorization by the end of 2027, Seoul Economic Daily reported in September.
In Korea, Sky Labs signed an agreement on September 29 with the Korean Society of Hypertension to analyze about 300,000 real-world CART readings and build standards for interpreting cuffless data, including day and night patterns and changes after treatment, Korea Biomedical Review reports. On LinkedIn, Sky Labs announced a cuffless blood pressure session at the Japanese Society of Hypertension meeting on October 11, a heart failure session at the Korean Society of Cardiology meeting on October 17, and its sponsorship of a new Established Investigator Award for Clinical Hypertension at AHA Hypertension 2026.
Oura finishes a blood pressure study and earns a medical device quality certification
Oura received ISO 13485 certification for its medical device software process, per Oura's announcement. ISO 13485 certifies a quality management process. Oura says the certification doesn't apply to any specific product and doesn't guarantee future clearances.
The more interesting line is about blood pressure. Oura says it "recently completed a large-scale blood pressure study through Oura Labs" and is exploring whether its data might inform future blood pressure features, "subject to appropriate regulatory review." Oura's ring doesn't give blood pressure readings in mmHg today. This comes a week after Oura postponed its IPO.
Teladoc adds camera-based vital signs to virtual visits
Teladoc Health announced SoloVitals, which uses a patient's phone or tablet camera to measure heart rate and respiratory rate during a virtual visit, per Healthcare Dive. It reads small changes in facial skin color, a method called remote photoplethysmography. It doesn't measure blood pressure. Teladoc calls the readings "clinically validated," and its announcement doesn't mention FDA clearance. I used to work at Teladoc, and was part of the R&D in this technology going back before 2019.
SoloVitals is in private preview, with general release expected in December. Teladoc also made SoloScribe, an ambient AI note-taking tool, generally available.
NHS awards Cambridge Heartwear a £184 million tender for its ECG wearable
NHS Supply Chain awarded Cambridge Heartwear a £184 million ($243.7 million) tender to deploy its HeartSense wearable across primary and secondary care, Medical Device Network reports. HeartSense is a reusable, multi-channel ECG wearable that streams to a phone for AI analysis. It's UKCA marked, and FDA 510(k) applications are underway. It records heart rhythm and doesn't measure blood pressure.
ARPA-H funds $117 million in wearable biosensor research
ARPA-H's Delphi program will spend up to $117.4 million over 4.5 years on small "chiplet" wearable biosensors, MedTech Dive reports. Awards include up to $37.9 million to MIT for a patch tracking heart failure biomarkers and $33.2 million to Novelna for a patch that monitors inflammation after a heart attack. None of the projects measures blood pressure, and all are early research.
Policy & Regulation
Utah moves toward third-party validation for health AI
Utah's Department of Commerce was expected to name a roster of AI validation companies on October 5 to vet and monitor participants in the state's AI regulatory sandbox, Second Opinion reports. Utah told sandbox applicants in August to plan for third-party validation. Christina Farr and Ruth Reader note this revives the "assurance lab" idea from the Coalition for Health AI, which HHS rejected in October 2025.
For anyone building AI into chronic care, this is one state's answer to a federal gap. I hope other states follow if Utah's pilots produce usable data.
An ACCESS Model participant joins Mayo Clinic Platform
Ciba Health, a virtual cardiometabolic and obesity care company that uses remote monitoring, is now listed as a qualified solution on Mayo Clinic Platform, per its announcement. Ciba says it was among the first participants in Medicare's ACCESS Model, which pays for outcomes in conditions including high blood pressure. It's an early sign of ACCESS participants using the model to win other distribution.
Clinical & Research
Intensive blood pressure control helped with or without kidney disease
A meta-analysis of 27 randomized trials and 88,830 people in JAMA Cardiology found each 10 mmHg drop in systolic pressure cut major cardiovascular events by 15%, Pharmacy Times reports. The benefit was similar in people with chronic kidney disease (11%) and without it (16%), and the difference wasn't statistically significant. Absolute benefit was larger with kidney disease: 4.2 compared with 2.7 events avoided per 1,000 person-years.
Declines in kidney function were more common with intensive treatment, but kidney failure wasn't. The authors recommend intensive targets for everyone, with kidney monitoring. Lower targets mean more titration steps, and more home readings between visits.
Remote blood pressure monitoring was safe in high-risk pregnancy
An Australian multicenter randomized trial of 270 women at high risk of pre-eclampsia found remote blood pressure monitoring was non-inferior to standard office monitoring, Labroots reports on the study in the American Journal of Obstetrics and Gynecology. Pre-eclampsia occurred in 19 of 131 women monitored remotely and 23 of 138 in standard care. The remote group had fewer appointments and no extra hospital visits.
Women measured three times a week on a validated monitor that sent readings by Bluetooth to an app, and clinicians called back on out-of-range readings. The trial was unblinded, and the authors call for a larger one. Not every home cuff is validated for pregnancy, so device choice matters here.
Cellular monitors grew a pharmacist-led hypertension program
A study in the Journal of General Internal Medicine, published in April and circulated in an industry newsletter this week, followed a pharmacist-led remote monitoring program across seven primary care clinics in Columbus, Ohio, per the journal. With Bluetooth monitors that needed a smartphone, the program enrolled 140 patients in 14 months. After switching to cellular monitors that sent readings straight to the medical record, it enrolled 167 patients in 9 months.
Average reimbursement per patient rose from $96.30 to $124.17. The study doesn't report blood pressure outcomes. We use cellular cuffs to reduce the points of failure, so this matches what we'd expect, and it's useful to see it measured.
WHO: only 23% of adults with hypertension have it under control
A World Health Organization feature from the Western Pacific region puts the number of adults 30 to 79 with hypertension at about 1.4 billion, with only 23% controlled, per WHO. It describes people dropping out at each step: late diagnosis, no dose adjustment, missed follow-up and access to medicine. WHO's HEARTS package, now used in more than 40 countries, calls for team-based care and getting readings back to the care team.
A Welsh pharmacy pilot found new hypertension and AFib cases
Four pharmacies in Wales screened 550 people over 40, sent those with high readings home with a monitor for a week, and had pharmacist prescribers treat confirmed cases, The Pharmaceutical Journal reports. The pilot found 51 new hypertension diagnoses and 2 previously unknown cases of atrial fibrillation. Access to GP records was the main barrier to scaling.
Also worth a glance
Apple owes Masimo $818 million. A court added $184.2 million in interest to a $634 million jury verdict over a blood oxygen patent in Apple Watch, MDDI reports. Apple plans to appeal.
Potassium-rich DASH diet looked safe on common BP medications. In a secondary analysis of 356 Black adults in Boston, potassium-rich DASH groceries didn't push serum potassium to dangerous levels in people taking ACE inhibitors, ARBs or potassium-sparing diuretics, per the American Heart Association. It's a meeting abstract and not yet peer reviewed.
A hot bath lowered blood pressure more than a bike ride. In 25 adults aged 45 to 70, 30 minutes in 40 °C water lowered blood pressure more than 30 minutes of moderate cycling, ScienceAlert reports. The authors call it a small study and suggest heat as an addition to exercise.
A brain region linked to sleep apnea and high blood pressure. Researchers in Brazil and New Zealand found that a brain region driving forceful exhalation raised blood pressure in rats, and switching it off brought pressure back to normal, ScienceAlert reports. The main findings are in animals only.
The thread this week
Most of this week's device news was measured against the cuff.
Happy Health validated against an arterial line, and FDA's draft guidance asks for a cuff comparison next time. Sky Labs is testing its ring next to a cuff-based 24-hour monitor to win a UK listing. Omron is working on a cuff that's easier to wear.
Cuffless devices are getting closer quickly. Until labels cover older patients, people on medication and readings during sleep, a validated home cuff is the reading clinicians act on. I expect that gap to keep narrowing, and I hope next year's clearances close a large part of it.
References
Premarket Notification 510(k) K254000: Happy Health Blood Pressure Monitor. U.S. Food and Drug Administration.
Happy Health becomes first company to receive FDA clearance for cuffless, calibrationless blood pressure measurement. EIN Presswire.
510(k) Summary K254000. U.S. Food and Drug Administration.
Biozen wins FDA nod for cuffless blood pressure measurement tech. MassDevice.
Cuffless Non-invasive Blood Pressure Measuring Devices: Clinical Performance Testing and Evaluation (Draft Guidance). U.S. Food and Drug Administration.
Terms of Use. Happy Sleep.
User Agreement. Happy Sleep.
Hypertension Prevalence, Awareness, Treatment, and Control Among Adults Age 18 and Older: United States, August 2021–August 2023. CDC National Center for Health Statistics.
Toward patient-centered blood pressure monitoring: first evaluation of a low-pressure and rapid oscillometric method for reducing cuff-related measurement burden. Hypertension Research.
Sky Labs begins UK validation study for CART BP Pro cuffless blood pressure monitor. Korea Biomedical Review.
Sky Labs eyes UK healthcare market with ring-type CART BP monitor. Korea Biomedical Review.
Sky Labs Targets U.S. Approval Next Year for Ring-Type Blood Pressure Monitor. Seoul Economic Daily.
Sky Labs, Korean hypertension society launch cuffless BP standardization study using 300,000 real-world records. Korea Biomedical Review.
Sky Labs Inc. on LinkedIn: JSH 2026, KSC 2026 and AHA Hypertension 2026. Sky Labs on LinkedIn.
ŌURA Earns ISO 13485 Certification for Medical Device Software. Business Wire.
Teladoc unveils remote monitoring, ambient AI features. Healthcare Dive.
Cambridge Heartwear receives $243m tender for HeartSense wearable. Medical Device Network.
ARPA-H awards more than $100M to biosensor development projects. MedTech Dive.
Assurance labs are back. Second Opinion.
Ciba Health's Precision Virtual Care Program Is Now a Qualified Solution on Leading Healthcare Platform. Business Wire via Yahoo Finance.
Intensive BP Control Cuts CV Risk Regardless of CKD Status. Pharmacy Times.
Structured Home Blood Pressure Monitoring is Safe for Pregnant Women. Labroots.
Growth and Financial Outcomes of a Remote Physiologic Monitoring Service for Hypertension in the Primary Care Setting. Journal of General Internal Medicine.
Why is hypertension so hard to get under control?. World Health Organization Western Pacific.
Hypertension pilot demonstrated pharmacy management of long-term conditions. The Pharmaceutical Journal.
Apple ordered to pay Masimo additional fees in patent infringement case. MDDI.
Potassium-rich DASH diet found safe for adults taking common blood pressure medications. American Heart Association.
A Hot Bath May Lower Your Blood Pressure More Than a 30-Minute Workout Can, Study Reveals. ScienceAlert.
Scientists Might Have Found a New Cause of High Blood Pressure, And a Way to Treat It. ScienceAlert.