The Week in Blood Pressure & Wearables — October 9-15, 2026
By Yair Lurie, Founder and CEO, Cardiowell. Published October 16, 2026.
Healthstats International, the Singapore company behind the BPro wrist blood pressure monitor, has shut down. BPro was on the market for almost two decades and held regulatory approvals in the US, Europe, the UK, and Australia. Its approvals are now canceled, or in the process of being canceled, and product support ended on December 31, 2025. That's this week's deep dive.
Also this week: a Wall Street Journal test of five blood pressure wearables, a new Sky Labs outcomes study, Whoop's entry into Medicare's ACCESS Model, FDA's guidance plans for 2027, and three AHA Hypertension 2026 abstracts worth knowing about.
Deep dive: Healthstats and BPro leave the cuffless blood pressure market
What happened
Healthstats International Pte Ltd posted a "Notice of Company Closure and End of Product Support" on its website. The notice, which I checked on October 16, says the company is "in the process of winding up and closing its operations."
It says all of its medical device approvals, registrations, and listings have been canceled, withdrawn, or are being canceled. It names six regulators: FDA, CE marking in the EU, UK medical device registration, Australia's TGA, Singapore's HSA, and Malaysia's MDA. The company no longer markets, distributes, or supports any medical device anywhere, and all product support and commercial activity ended on December 31, 2025.
Public records match the notice. FDA's device identifier database lists the BPro BT Ambulatory Blood Pressure Monitoring System as "Not in Commercial Distribution," with an end date of December 31, 2025, per AccessGUDID. Australia's TGA shows the BPro registration canceled at the sponsor's request on February 11, 2026, per the TGA.
Researchers noticed. On October 6, Isabella Tan, Alberto Avolio, Mark Butlin, Sonali Gnanenthiran and Genevieve Gabb published a letter in the Journal of Human Hypertension titled "A key player in the cuffless blood pressure devices market has exited – a cautionary tale for cuffless blood pressure monitoring?" per Nature. They write that the company "quietly withdrew after almost two decades." The full letter is behind a paywall, so I've only been able to read its opening section.
What BPro was, and how it measured blood pressure
BPro looked like a watch, and it measured blood pressure differently from today's optical rings and smartwatches.
FDA cleared the original BPro system in April 2006. According to the 510(k) summary, it was "based on arterial tonometry at the radial artery of the wrist." A pressure sensor pressed against the artery at the wrist and recorded the pulse wave. Before each recording session, it was calibrated with a separate oscillometric upper-arm cuff. It was cleared for adults 18 and older, took up to 96 readings in 24 hours, was prescription-only, and did not make a diagnosis.
An updated BPro BT received a Special 510(k) in 2018, with the same tonometry method and cuff calibration, per FDA. Healthstats also built central aortic pressure products, the A-Pulse CASPro and CASPal, which combined an arm cuff with wrist tonometry, per FDA.
The Journal of Human Hypertension letter describes BPro as a cuff-calibrated wrist device that passed the European Society of Hypertension protocol and the ANSI/AAMI SP10:2002 standard. Both were written for cuff devices. BPro was approved before any validation standards for cuffless devices existed, and it was used clinically for 24-hour ambulatory blood pressure monitoring (ABPM).
Why did the company exit?
I couldn't find a source that says. The company's notice gives no reason; the visible part of the letter gives none, and I found no statement from company leadership.
Here's what the public record does show:
A 2019 Singapore High Court judgment states that Healthstats "operated at a loss annually since its inception in 2000," with accumulated losses exceeding S$44 million by 2017, according to the court record. The same judgment describes a 2017 investment that gave a new investor a majority stake, and a dispute with the founders.
In April 2026, the company's registered address moved to the office of Rivulets Investments, a Singapore-based real estate fund manager, according to company registry data and Rivulets' listing. Legacy inquiries now go to a Rivulets contact.
The Singapore registry still lists the company as live. I found no liquidator appointment and no successor medical device business.
I don't see anything that indicates a pivot to a new device. It reads like an orderly wind-down.
My view, and it is only that: four pressures probably added up. ABPM is a narrow market. Medicare covers it once a year for suspected white-coat or masked hypertension, per CMS, and the payment is small for a device that must be fitted, worn, and returned. Keeping approvals current in six jurisdictions costs money every year. The validation bar for cuffless devices rose with the 2023 ESH recommendations, IEEE 1708-2025, and the FDA's January 2026 draft guidance. A device validated under older cuff standards would likely need new studies to compete. And newer cuffless devices arrived with venture funding behind them.
None of that is documented as the reason. It's how I'd read the situation as someone who runs a hypertension business. I assume any cuffless ABPM device that is currently in market will need to be resubmitted if they don’t meet the soon to be adopted 2026 guidance.
What it means for clinics and buyers
A regulatory clearance belongs to a company. When the company winds up, the clearance can be withdrawn, the software stops getting updates, and support ends. The device on the shelf still works for a while, but nobody supports it.
For a clinic, the practical questions come before purchase:
Who holds the clearance, and is it for the exact model you're buying?
What happens to support, software, and your patients' data if the vendor exits?
Can you export the readings in a usable format today?
Is there a second device that can take over without having to start your program from scratch?
Cardiowell’s BT107 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 standard and a label limited to what the evidence supports. That clearance indicates to a clinician that the readings meet a standard. It doesn't tell them the company will be around in ten years, so we look at both.
Why this matters now
This is happening during the busiest stretch the cuffless category has had. Happy Health's ring received FDA clearance for cuffless, calibration-free spot checks in adults aged 22 to 50, per the FDA database we covered last week. Sky Labs started a UK study comparing its CART BP Pro ring with cuff-based 24-hour monitoring, aiming for inclusion on the British and Irish Hypertension Society's validated device list, per Korea Biomedical Review. Biobeat, the first cuffless 24-hour ABPM device, has been on the market for a couple of years.
BPro shows that validation and approvals are necessary but still not enough. A device also needs a business that can pay for support and keep up with new standards for years.
I'm optimistic about the category. BPro was early, and it did 24-hour wrist monitoring years before rings could. The companies coming now have better sensors, clearer validation rules to aim at, and more clinicians willing to use the data. I hope the ones that last plan for the long run from day one, and I hope buyers ask them how.
Devices & Wearables
The WSJ tested five blood pressure wearables, and each one does something different
The Wall Street Journal published a hands-on review, "Can Wearables Really Track Blood Pressure Without the Cuff? I Tested Them," covering the Oura Ring, Hilo Core, Google Pixel Watch 5, Whoop band and Apple Watch, per the WSJ. The full article is behind a paywall.
The five devices aren't the same kind of product:
Apple Watch uses its optical heart sensor over 30-day windows to flag possible hypertension. It doesn't show blood pressure numbers and recommends confirming with a cuff, per Apple. FDA cleared the notification feature in September 2025, per Cardiovascular Business. The FDA clearance covers Series 9, Ultra 2, and later, for users 22 or older who aren’t pregnant and haven’t already been diagnosed. You have to wear it at least 14 of 30 days. No flags came up during the test.
Hilo (formerly Aktiia) is an optical bracelet calibrated with an arm cuff. Its bracelet received an over-the-counter 510(k) in July 2025, per Fierce Biotech. I couldn't confirm from public sources whether the Hilo Core band sold in the US today is marketed under that clearance. It’s the only one that gives actual systolic and diastolic numbers, after four days of calibrating against a cuff. It sent 8–10 readings a day, but there were hours-long gaps during exercise because it only measures at rest. Weekend readings were noticeably lower than weekday ones, which the article ties to work stress. It costs $90 for the band plus an FDA-approved cuff, then $150 a year; the band stops working if you don’t renew, but the cuff keeps working.
Whoop estimates blood pressure after a cuff calibration and sells it as a wellness feature. FDA closed its warning letter after Whoop changed the feature, per STAT. Part of the $359-a-year “Life” plan. You take three cuff readings to establish a baseline, then it estimates a resting range based on sleep data. Its estimates were close to a cuff reading taken right after waking. The app shows green, yellow, or orange compared with your baseline.
Google Pixel Watch 5 estimates monthly blood pressure trends from pulse and motion, with no cuff or calibration. Google says the feature is "intended for general wellness purposes only" and is "not a prescreener for hypertension," per Google. Starts at $400. After at least five days and nights of wear, the Google Health app rated the trend “Not high.” The feature is reportedly coming to Fitbit Air later this year with a $99-a-year Google Health Premium subscription.
Oura doesn't show blood pressure readings in mmHg. It said last week that it finished a large blood pressure study. No numbers. It tracks how much blood pressure drops overnight and monthly trends; it costs $349 plus $6 a month. One night showed a 21% drop (typical is 10–20%), which the article links to flu and COVID shots that day. No 30-day trend alert came up.
A clinic will get questions about all five. Apple's notification feature and Hilo's bracelet have FDA clearances, and Apple's gives an alert rather than a number. The other three are wellness features. All devices will have a hard time with an ROI based on insurance reimbursement.
Fitbit Edge will carry Google's blood pressure trends
Google announced the Fitbit Edge, a $179.99 tracker with an ECG app, SpO2 and skin temperature sensors, Fierce Healthcare reports. The blood pressure trends feature from the Pixel Watch comes to Edge through a Google Health Premium subscription. Google also announced a multiyear partnership with and investment in the women's health app Flo Health, per MobiHealthNews.
That puts a cuffless blood pressure estimate on a sub-$200 band. It's a wellness feature, so patients will bring trends to their visits, and clinicians will still need cuff readings to act on.
Sky Labs reports outcomes with its ring and presents at three meetings
A study at Korea University Anam Hospital, published in Clinical Hypertension, followed 246 patients with uncontrolled hypertension for six months, Korea Biomedical Review reports. In 67 patients, doctors adjusted medication based on 24-hour readings from Sky Labs' CART ring, and 179 received usual care.
At six months, 65.8% of the CART group had controlled blood pressure, compared with 36.3% in usual care, and 24-hour systolic pressure was 7.35 mmHg lower after adjustment. The CART group added more medication classes (0.85 vs 0.37). Patients weren't randomized; only 162 completed the six-month measurement, and the researchers call for a randomized trial. The results come from Sky Labs' announcement.
The finding I'd focus on is the extra medication. The ring gave doctors more readings, and they titrated more. That matches what we see in hypertension programs: more data helps when someone acts on it.
On LinkedIn, Sky Labs announced that Dr. Annet Kirabo is the first recipient of the AHA Established Investigator Award for Clinical Hypertension, which Sky Labs sponsors, and that it is presenting CART BP pro at the Korean Society of Cardiology meeting on October 17, including a session on cuffless monitoring in heart failure.
CART BP pro is a finger ring with an optical (PPG) sensor, calibrated with a cuff, per Korea Biomedical Review. It's approved and reimbursed in Korea, holds CE marking and UK MHRA registration, and isn't FDA authorized. Disclosure: Cardiowell has an integration relationship with Sky Labs.
Policy & Regulation
Whoop is in Medicare's ACCESS Model, and blood pressure is on its scorecard
Whoop was accepted into the ACCESS Model this year and is free to many traditional Medicare patients 65 and older, STAT reports. Patients get a band, a 12-month app subscription and access to clinicians, and Whoop serves people with high blood pressure, high cholesterol, obesity and prediabetes. To get full payment, it must show improvement or control in blood pressure, HbA1c and LDL.
Whoop's chief medical officer, Ami Bhatt, said the company has shown a 5 mmHg drop in blood pressure for people on Whoop. STAT doesn't describe the methodology.
ACCESS pays for outcomes, so every participant will need blood pressure numbers that hold up. I'd expect Whoop to rely on validated cuff readings for the outcome measure. That's my assumption; the article doesn't say.
Providers are planning around ACCESS but doubt it will pay
A NAACOS and Innovaccer survey of 116 provider and value-based care leaders found 72% say ACCESS is changing their technology strategy, but only 30% expect ACCESS payments to fund it, Medical Economics reports. Only 21% formally track which of their patients are enrolled in ACCESS. Innovaccer sells an ACCESS product.
Referring clinicians get a $30 co-management payment per track, up to three times per patient, plus a one-time $10 add-on, per the article. ACCESS started July 5 and covers hypertension in its early cardio-kidney-metabolic track, per CMS.
FDA's 2027 guidance list has no cuffless blood pressure item
FDA's device center published the guidance documents it plans to work on in fiscal 2027, per FDA. AI is the main theme, with final guidance on AI-enabled device software and a first draft on generative AI for mental health. Blythe Karow walks through the list in The Device Files, including UpDoc, the first publicly identified patient-facing LLM device, cleared through a 510(k).
Two items under construction matter for blood pressure devices: guidance on selecting a predicate device for a 510(k), and updates on how FDA evaluates substantial equivalence. The January 2026 draft guidance on cuffless blood pressure devices isn't on any list, so I wouldn't count on a final version in the next year.
Utah lets AI renew blood pressure prescriptions, with a physician checking every one
Utah added five pilots to its health AI sandbox and named six independent evaluators, including the Coalition for Health AI and Stanford's Clinical Excellence Research Center, Second Opinion reports. One pilot lets August AI renew low-risk chronic medications, including frontline blood pressure drugs, for $4 per refill, Becker's reports.
A Utah-licensed clinician reviews every decision at launch. The plan is to step down to spot-checks of 5%, with each step validated by an evaluator and approved by the state. New prescriptions and dose changes are excluded. That's the right boundary for now. A refill is the easy part, and titration is where most of the work is.
CMS is suspending payments to some care management startups
Some companies billing Medicare monthly for chronic care management and navigation services face payment suspensions as part of a federal fraud crackdown, Second Opinion reports. The article says only a small subset of codes is being exploited and not every company is a bad actor. The details are behind a paywall.
Clinical & Research
Masked hypertension was linked to more falls in people over 78
In 758 adults aged 78 to 98 from the ARIC cohort, those with masked hypertension — normal blood pressure in the office but high at home — had a 70% higher risk of falls than those with high readings in both places, per the American Heart Association. About 15% of participants had masked hypertension, and 82% were on blood pressure medication.
It's a meeting abstract from Hypertension 2026 and isn't peer-reviewed yet. It's one more reason home readings matter in older patients, since an office reading alone missed this group.
Better blood pressure control could prevent about 518,000 deaths a year in 20 countries
A Johns Hopkins modeling study of 20 middle-income countries found that raising blood pressure control to about 80% coverage would prevent 518,476 cardiovascular deaths a year, more than statins (340,682) or glucose control (309,520), per the American Heart Association. About 1 in 5 adults with hypertension in these countries has it under control. It's also a meeting abstract.
AI chatbots got home blood pressure monitor validation right about two-thirds of the time
Researchers in Montreal asked Gemini, ChatGPT, Copilot, and Perplexity whether 324 home monitors were validated, per the American Heart Association. Gemini was right 86% to 91% of the time, and the others ranged from about 63% to 83%. All four did worse at recognizing validated devices, and answers changed on retest.
Patients are asking chatbots which monitor to buy. Clinicians can point them to the US Validated Device Listing instead.
Two vendors published remote monitoring results for hypertension
Prevounce analyzed patients with stage 1 or 2 hypertension enrolled in its remote patient monitoring (RPM) program with cellular cuffs, per Prevounce. Systolic pressure fell by 5.5% at three months in 655 patients and by 6.3% at nine months in 324 patients, with larger drops in stage 2. There's no control group; the analysis is by company staff, and half the patients didn't have nine-month data.
CareTrack and Tanner Health in Georgia reported that patients starting above 140 systolic who stayed in their RPM program saw their average systolic pressure drop from 151.6 to 143.2 mmHg, per their announcement. The release doesn't give sample sizes.
Both point the same way as other real-world data. Neither is a trial, and the same caveats apply to anyone's vendor data, including ours.
Also worth a glance
RingConn's smart ring received 510(k) clearance for blood oxygen monitoring. The clearance, K260490, covers SpO2 measurement, per BioPharma APAC. It doesn't cover blood pressure.
The thread this week
Most of this week focused on what happens after a device is approved.
BPro had approvals in six jurisdictions and still left the market. Whoop and others in ACCESS will be paid based on blood pressure outcomes, so their readings must hold up for a year. Sky Labs is publishing outcome data, and two RPM vendors have published theirs. FDA's next round of guidance focuses on AI and 510(k) predicates, with cuffless blood pressure still in draft.
A clearance gets a device to market; staying there requires support and outcome data. I expect the cuffless field to keep growing, and I hope the companies in it, and the clinics buying from them, plan for the long term.
This column is also published on the Cardiowell blog: [ARTICLE URL — cardiowell.com, not yet published]
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References
Healthstats International | Ambulatory Blood Pressure Monitoring. Healthstats International.
AccessGUDID: BPro BT Ambulatory Blood Pressure Monitoring System. U.S. National Library of Medicine and FDA.
Sponsor regulatory activities: HealthSTATS Australia. Therapeutic Goods Administration.
A key player in the cuffless blood pressure devices market has exited – a cautionary tale for cuffless blood pressure monitoring?. Journal of Human Hypertension.
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510(k) Summary K173028: BPro BT with BProSoft BT. U.S. Food and Drug Administration.
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