FDA Backs Off: WHOOP Tweaks Blood Pressure Feature and Stays in the Clear

When WHOOP launched its blood pressure measurement feature straight from the band last year, the FDA wasn't thrilled. The US regulator had concerns—and made them known. Now, after WHOOP made some adjustments, the FDA has dropped its enforcement action. STAT News reported it on June 23, 2025, and it's worth digging into what this actually means. Especially for those of us wearing WHOOP daily and wondering where health tracking is headed.

What Actually Happened

WHOOP rolled out a blood pressure estimation feature as part of WHOOP Body—wearable clothing with embedded sensors. The catch? Blood pressure measurement is a regulated area in the US. The FDA classifies these kinds of features as medical devices that need approval, similar to how the EKG works on Apple Watch.

WHOOP launched the feature without full FDA clearance. The regulator started pushing back. WHOOP responded pragmatically: they changed how the feature is presented and what language they use to describe it. Specifically, they shifted from calling it "blood pressure measurement" to a softer description that doesn't sound like a diagnostic tool. After those tweaks, FDA enforcement ended.

So it's not exactly "FDA approval." It's more like WHOOP took a step back on the marketing side, and FDA said: "Okay, we can live with that."

Why This Matters for Wearables

This decision sets an interesting precedent. It shows where the line sits between a wellness feature and a medical device—and that line is heavily about how you talk about it, not just the technology itself.

For the broader wearables market, this signals:

• Manufacturers can offer advanced health metrics as long as they don't market them as clinical diagnostics.
• FDA doesn't necessarily want to block innovation—but they insist users aren't misled about accuracy or purpose.
• Other companies (Garmin, Apple, Samsung) are watching this closely and will adjust their own blood pressure strategies accordingly.

It's partly a game of semantics. But in regulation, words are everything.

What It Means for US Users

Directly? Not much changes right now. The blood pressure feature is tied to WHOOP Body, which isn't widely available in the US market yet. And even if it were, the real question is what comes next.

This ruling matters more as a signal. WHOOP just proved it can offer blood pressure data—with careful framing. That increases the odds the feature survives and evolves. And it shows other wearable makers what's possible.

Indirectly, the impact is real:

• WHOOP validated that it can ship blood pressure data with the right messaging. That raises the ceiling for what the company can build next.
• Heart Screener and other health features in WHOOP 5.0 show the direction the company is heading. FDA approval (or at least, FDA non-enforcement) in the US is critical because that's where the biggest market is.
• If WHOOP can navigate these regulatory waters smoothly, expect more advanced health metrics to roll out—not just for WHOOP, but for the whole industry.

My Take: Cautiously Optimistic

I've been following wearables regulation for about a year and a half. Not because I love bureaucracy, but because it directly affects what features land on my wrist.

I read the FDA's move on WHOOP as a positive signal. Not because WHOOP "won"—more because FDA showed a willingness to be pragmatic. They didn't say "we're banning this." They said "rebrand it so it doesn't look like a clinical device." WHOOP complied. Done.

That said, I'm slightly uneasy about how much hinges on wording. The technology is the same—the sensor measures what it measures. The difference is just how it's labeled in the app. For us users, that's a bit absurd. But I get why it matters. When your watch tells you "your blood pressure is high," that hits different than "your BP trend estimate moved up." The first can trigger panic or false reassurance. The second is more honest.

What to Watch

• Whether WHOOP pursues broader FDA clearance for blood pressure in the future.
• How Apple and Samsung respond—both have blood pressure in their roadmaps and now they see how far FDA will let wearables go without full clearance.
• Whether WHOOP adjusts how it frames Heart Screener based on this precedent.

Wearables regulation is moving faster than ever. And for those of us wearing WHOOP every day, it's ultimately good news—it means companies are pushing the boundaries of what they can offer us.