The Week in Blood Pressure & Wearables — October 16-22, 2026
By Yair Lurie, Founder and CEO, Cardiowell. Published October 23, 2026.
Signal Ring, a $399 finger ring that reports blood pressure without a cuff, is now payable with FSA and HSA funds and starts shipping in the coming weeks. Its own press release says it "has not yet been reviewed or cleared by the FDA" and "is not a medical device." That's this week's deep dive.
Also this week: Congress keeps pushing CMS on its remote monitoring rule ahead of a final rule due by November 1, a kidney society commentary says everyone with high blood pressure should get a urine albumin test, a Quest study argues current screening misses half of primary aldosteronism, and a Maryland study links chronic care management to fewer hospital stays.
Deep dive: Signal Ring brings a cuffless blood pressure ring to market as a wellness product
What happened
On October 20, Vital Signals, Inc. of San Francisco announced that its Signal Ring can be bought with FSA and HSA funds, per PR Newswire. The ring costs $399 with no subscription. The company says pre-orders came from 48 states and that rings will ship "in the coming weeks."
The release doesn't explain how FSA and HSA eligibility works. The Signal Ring website names Truemed, a third-party service, as the provider for qualifying customers.
The company also named Peloton instructor Matt Wilpers as a brand ambassador. CEO Tom Moss says he has lived with high blood pressure himself.
How it measures blood pressure
Signal Ring is a titanium ring with an optical (PPG) sensor on the finger. The company says it uses a "proprietary physiological model" and signal features developed over about three years, per MDDI.
It needs no cuff for setup or ever. That's the company's main claim, and it's what sets the ring apart from cuff-calibrated optical devices like Hilo's bracelet or Sky Labs' CART BP pro. Moss told MDDI that cuff-calibrated methods can drift over time.
The ring takes background readings day and night. It also has a guided, seated reading called Zen Mode and real-time sessions that refresh every 10 seconds. Readings are processed in the cloud, so the phone needs a data connection, per Android Authority.
What it claims about accuracy
At its July launch, the company said Signal Ring's accuracy "has been validated in a 451-person clinical study across multiple sites" and that it "meets the requirements of ISO 81060-2, the international accuracy standard for blood pressure cuffs," per PR Newswire. The same release says the algorithms were "tested on thousands of subjects." It doesn't reconcile the two numbers.
I couldn't find the study published anywhere, and I found no accuracy figures, reference method, or site list in any public source.
The standard named matters. ISO 81060-2 was written for cuff devices. The European Society of Hypertension's 2023 recommendations say cuffless devices raise accuracy issues that need different validation from classic cuff monitors, per the published abstract. ESH defines six tests: static accuracy, device position, detecting a drop after treatment, awake-to-asleep changes, detecting a rise with exercise, and calibration stability over time. Not every device needs every test. For a ring that reports readings all day and night, I'd want to see the change-tracking tests most.
IEEE 1708-2025, a standard written for wearable cuffless devices, is now published. FDA's January 2026 draft guidance on cuffless devices is still a draft.
The regulatory position
The October release states: "Signal Ring has not been reviewed or cleared by the FDA and is currently investigational." It also says the product "is not a medical device" and is not intended to diagnose, treat, cure or prevent disease. The website adds that it shouldn't be used for decisions about medication or treatment.
Moss told MDDI the company is launching it as a wellness device and is "also pursuing FDA 510(k) clearance." No timeline was given.
That wellness path exists because of FDA's revised general wellness guidance, issued January 6, 2026. It allows non-invasive blood pressure estimation products to qualify as wellness products, with conditions, per Covington. A wellness product can't claim "clinical equivalence, clinical accuracy, or medical grade," can't reference diseases or diagnostic thresholds, and needs validation if it shows values that mimic clinical ones. That's a reversal from mid-2025, when the FDA's warning letter to Whoop took the position that blood pressure features are regulated devices. One FDA lawyer describes the 2026 guidance as "not a green light for blood pressure claims," per FDA Attorney.
Whether any specific marketing line fits inside those conditions is FDA's call, and I'm not going to make it here.
How this compares with Happy Health's cleared ring
Last month, FDA cleared Happy Health's ring for cuffless, calibration-free spot checks in adults 22 to 50, per the FDA database. We covered it on October 9.
The two rings look similar on paper. Both are optical finger rings, and neither needs a cuff. The difference is what each company can say and who reviewed the evidence. Happy's label is narrow: spot checks, a set age range, and the testing FDA accepted. Signal's claims are broader, all day and all night, and no regulator has reviewed them.
Cardiowell’s BT107 ‘always-connected’ blood pressure monitor is FDA 510(k) cleared. In general, a 510(k) requires a manufacturer to show 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 method under a recognized standard, with the label limited to what the data supports. When a clinician sees that clearance, they know someone outside the company checked the numbers.
What it means for clinics
Patients will bring Signal Ring readings to visits, and some will have paid for the ring with pre-tax health dollars. FSA and HSA eligibility is a tax question. FDA review is a separate one.
For now, a clinic can treat these readings as the company's disclaimer does: as context, with medication decisions left to validated measurements. A high trend is a reason to confirm with a validated home cuff or 24-hour ambulatory monitoring.
My view: calibration-free cuffless measurement is the hardest problem in this category, and a company that solves it will change hypertension care. Happy Health's clearance shows it can be done for a defined use. I'd like to see Signal's 451-person study published with the reference method and error figures, and tested against the ESH cuffless protocol. I hope the 510(k) moves quickly. If the data holds up, clinicians get one more way to see blood pressure outside the office.
Devices & Wearables
Sky Labs brings cuffless monitoring to the International Society of Hypertension meeting
Sky Labs is exhibiting at ISH-ECS 2026 in Dubai, October 22-25, and scheduled its first ISH lunch symposium on cuffless monitoring in hypertension care for October 22, Sky Labs announced on LinkedIn. Professors Kazuomi Kario and Sang-Hyun Ihm were listed as chairs, with talks by Professors Alta Schutte and Hae-Young Lee.
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. I found no change to that status this week. Disclosure: Cardiowell has an integration relationship with Sky Labs.
Wellysis gets a 510(k) for AI analysis of its ECG patch
Wellysis, a Samsung SDS spin-off, received FDA 510(k) clearance for S-Patch CardioAI, software that analyzes ECG data from its already-cleared S-Patch wearable for arrhythmias, MobiHealthNews reports. It's built to plug into apps used by remote patient monitoring (RPM) providers and diagnostic testing facilities.
This is ECG software. I expect more RPM vendors to offer rhythm data alongside blood pressure.
Policy & Regulation
The RPM rule fight continues, with a final rule due by November 1
CMS's CY 2027 Physician Fee Schedule proposal would pay for remote physiologic monitoring only when the billing practice's own employed clinical staff do the work, require an initiating visit, and revalue the device supply codes by tying them to the self-measured blood pressure codes, per Prevounce. We covered the proposal on September 25.
The pushback grew this month. Thirty-two House members, led by Reps. David Kustoff and Troy Balderson, asked CMS Administrator Mehmet Oz to withdraw the staffing restriction, Fierce Healthcare reports. Sens. Mark Warner and Marsha Blackburn sent their own letter in September. A National Association of Rural Health Clinics survey found nearly 70% of rural clinics offering RPM rely on outside partners. On October 22, the Washington Examiner reported that critics expect rural seniors and rural hospitals to be hit hardest.
Current billing rules stay in place through December 31. The final rule is expected by November 1, so next week's edition may have the answer.
For hypertension programs, the staffing question decides who reviews the readings and gets paid for it. I hope CMS keeps the fraud controls and finds a way for small and rural practices to keep using partners.
Baba raises $40 million and qualifies for all four ACCESS tracks
Baba, an AI-assisted care navigation company, raised a $40 million Series A, per HLTH. It says it qualified for all four clinical tracks of CMS's ACCESS Model, including early cardio-kidney-metabolic conditions such as hypertension. Baba pairs care coordinators and social workers with AI agents for referrals, discharge coordination, and insurance disputes.
ACCESS keeps drawing funded companies. Each one will be paid on measured outcomes, and for the hypertension track that means blood pressure readings that hold up.
A simple way to sort healthcare AI by risk
In The Device Files, Blythe Karow sorts AI health products with two questions: is the work clerical or clinical, and is it physician-facing or patient-facing? Clinical and patient-facing is where FDA attention, liability and opportunity are highest. She places UpDoc, the first cleared patient-facing LLM device, at the careful edge of that quadrant, because its dosing logic comes from parameters a physician sets.
That framing is useful for anyone building patient-facing AI for blood pressure, including us with BP Buddy. The closer an AI gets to telling a patient what to do about a reading, the more evidence it needs.
Clinical & Research
Kidney experts say every patient with high blood pressure should get a urine albumin test
The National Kidney Foundation published a KDOQI commentary on the 2025 AHA/ACC high blood pressure guideline, focused on people with or at risk for chronic kidney disease, per NKF. The guideline recommends a urine albumin-to-creatinine ratio (uACR) test for all patients with hypertension. NKF says fewer than 10% of patients with high blood pressure alone get one.
The commentary supports a target below 130/80 mmHg with individualized care, endorses the PREVENT risk calculator, and calls for correct cuff size, positioning, rest, and repeated readings.
Current screening may miss half of primary aldosteronism
A Quest Diagnostics study of more than 60,000 patients, published in Hypertension, compared the 2025 Endocrine Society screening criteria with looser criteria, per Quest. The looser criteria flagged 26.2% of patients compared with 13.0%. Most of the extra patients had aldosterone between 5 and 7.5 ng/dL.
It's retrospective, with no confirmatory testing, and Quest ran it. Primary aldosteronism is a treatable cause of hard-to-control blood pressure, so anyone running a hypertension program should watch where the thresholds land.
Chronic care management was linked to fewer hospital stays in Maryland
In 2,370 matched high-risk primary care patients in the Maryland Primary Care Program, those engaged in nurse-led chronic care management had 0.22 fewer hospitalizations and 0.20 fewer ER visits per person over six months, and $3,008 lower acute care spending, per a summary of the Journal of General Internal Medicine study. Thirty-day readmissions didn't change.
It's observational, and the participants started with much higher acute care use. Still, it's useful evidence as CMS questions how care management codes are being billed.
Also worth a glance
Telmisartan and amlodipine recall. Viatris recalled 21,620 bottles of 40 mg/5 mg tablets in a Class III recall because telmisartan content may exceed specifications, per NTD.
A twice-yearly shot for blood pressure. Duke investigators presented an exploratory KARDIA-3 subgroup analysis of zilebesiran, an investigational RNA therapy, per Duke. The post-hoc finding can't establish who responds best.
Measure before your morning water. A Seoul Economic Daily piece reviews studies showing drinking water right after waking can raise readings, and repeats the advice to measure within an hour of waking, before breakfast and medication, per Seoul Economic Daily.
Wearable HRV accuracy. A 23-person study in Sensors found a Garmin Forerunner 955 reliable for resting heart rate against ECG, but said its HRV "lacks the absolute accuracy required," per Forbes. Garmin noted the watch uses older hardware.
Digital health funding. Startups raised $3.7 billion across 114 deals in Q3, with $11.1 billion year to date, according to Rock Health's Q3 update, per Second Opinion.
The thread this week
Most of this week was about who checks the numbers.
Signal Ring is shipping blood pressure readings that no regulator has reviewed. The kidney commentary reminds clinicians that cuff size and positioning still decide whether a reading is right. Quest's study questions the thresholds used to find one cause of high blood pressure. And CMS is deciding who can review RPM readings and get paid for it.
The devices are getting better fast. I expect more cuffless rings and more AI reading the data. I hope the evidence keeps pace, and I hope clinics keep asking to see it.
References
Signal Ring Now FSA and HSA Eligible with Shipping to Begin in October. PR Newswire.
Signal Ring. Vital Signals, Inc.
Can the new Signal Ring do what Oura, Whoop, and Apple wearables can't?. MDDI.
This new smart ring wants to change how you track blood pressure. Android Authority.
Signal Ring Unveils World's First Truly Cuffless Blood Pressure Tracker for Everyday Wear. PR Newswire.
European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices. Macquarie University.
IEEE 1708-2025: IEEE Standard for Wearable, Cuffless Blood Pressure Measuring Devices. ANSI Webstore.
FDA Issues Revised Guidance on General Wellness Products. Covington & Burling.
FDA General Wellness Guidance 2026: What Wearable And Digital Health Companies Can And Can't Do Now. FDA Attorney.
Premarket Notification 510(k) K254000: Happy Health Blood Pressure Monitor. U.S. Food and Drug Administration.
Sky Labs Inc. on LinkedIn: We're exhibiting at ISH-ECS 2026 in Dubai!. Sky Labs on LinkedIn.
Sky Labs eyes UK healthcare market with ring-type CART BP monitor. Korea Biomedical Review.
510(k) for ECG AI, Chinese smart ring and more briefs. MobiHealthNews.
The Pushback on CMS's Proposed 2027 Changes to RPM. Prevounce.
Lawmakers press CMS to roll back proposed restrictions on remote patient monitoring. Fierce Healthcare.
New Medicare rule threatens telemedicine access for rural seniors. Washington Examiner.
Baba Secures $40M to Expand AI-Powered Medicare Care Navigation and Launches BabaBench. HLTH.
Who's in the Driver's Seat?. The Device Files (Blythe Karow).
National Kidney Foundation Highlights New Blood Pressure Guidance Putting Kidney Health at the Forefront. National Kidney Foundation via PR Newswire.
Current Screening Thresholds May Miss Half of Patients with Primary Aldosteronism, a Leading Cause of Severe High Blood Pressure, Finds Study in Hypertension. Quest Diagnostics.
Observational Maryland study links chronic care management to lower acute care use. Bioengineer.org.
Blood pressure medication recalled nationwide over superpotent drug. NTD.
Twice-yearly shot could transform blood pressure treatment. Duke University School of Medicine.
Morning glass of water can skew blood pressure readings. Seoul Economic Daily.
Garmin Forerunner Watch Accuracy Issue Highlighted In Study. Forbes.
Who pays for AI oversight?. Second Opinion.