The FDA Cleared the First Cuffless Blood Pressure Wearable. Rivals Dodged Clearance by Calling It Wellness.

The Food and Drug Administration cleared Happy Health's ring on September 3, 2026, as the first wearable authorized to report blood pressure on an ongoing basis with no inflatable cuff and no separate calibration step. The clearance, filed under submission K254000, covers a ring the Austin, Texas company has sold since 2024 for tracking sleep, pulse, and blood oxygen. Blood pressure is new.

Every other wearable that reports a blood pressure number still leans on a cuff somewhere in the process. Samsung's Galaxy Watch asks users to recalibrate against an upper arm cuff every 28 days. The Hilo Band, cleared for over the counter use in July 2025, runs the same monthly cycle. Apple's Watch, cleared in September 2025, skips the cuff but also skips the number. It reads 30 days of optical pulse data and tells some users they may have hypertension, without stating what their pressure actually is.

What the validation study measured

Happy Health tested the ring against radial arterial catheterization, the invasive method cardiologists use as a reference standard, across 850 paired measurements in 85 subjects. The company reported a systolic mean error of 0.8 mmHg and a diastolic mean error of 0.1 mmHg, both well inside the 5.0 mmHg ceiling set by the ISO 81060-2 standard that FDA reviewers use to judge blood pressure devices. Eighty five subjects is also the minimum sample size that standard requires, not a number Happy Health chose on its own.

The study is Happy Health's own, run and funded by the company, and it has not yet appeared in an independent peer reviewed journal. The FDA's 510(k) pathway asks whether a device is substantially equivalent to one already on the market, not whether it outperforms every alternative, and the public clearance record lists the decision as exactly that: substantially equivalent, under product code DXN, reviewed by the agency's cardiovascular panel. How the ring performs on people with irregular heart rhythms, darker skin tones, or pregnancy related blood pressure changes is not addressed in that record.

How the competition stacks up

• Happy Health, Happy Ring: FDA cleared September 3, 2026, for continuous blood pressure with no cuff and no calibration.
• Hilo Band: FDA cleared July 2025 for over the counter use, requires monthly calibration against an upper arm cuff.
• Apple Watch: FDA cleared September 2025 for a hypertension notification only, no blood pressure number, sensitivity of about 41 percent.
• Samsung Galaxy Watch: no FDA clearance in the United States, classified as a wellness feature, requires calibration every 28 days.
• Whoop and Oura: no FDA clearance, both classified as wellness features rather than medical devices.

Samsung's feature carries no FDA clearance at all in the United States. The company positions it as a wellness feature under the FDA's January 2026 guidance for general wellness products, a category that does not require the clinical testing a medical device clearance demands. Whoop and Oura, the two best known ring and band competitors, sit in that same wellness category. Choosing that path means a faster launch and a lower bar, at the cost of not being able to call the reading a medical one.

Who built it

Happy Health's leadership includes chief executive Dustin Freckleton and co-founders David Clift-Reaves, Carlos Martinez Garcia, and Caroline Chow. The company has raised at least 135 million dollars since a 2022 Series A led by ARCH Venture Partners, including a 75 million dollar round in August 2026 backed by ARCH and OpenLoop, funding that closed a month before the new clearance came through.