FDA Closes WHOOP Case: What Changed With Blood Pressure Tracking

A few months back, the FDA sent WHOOP a warning letter over its blood pressure measurement feature. Now the case is closed—the FDA withdrew the letter. But not because the regulator waved it off. WHOOP had to redesign the feature. Here's what technically changed, why this isn't just a "PR win," and what it means if you're wearing WHOOP in the US.

What Was the Problem?

When WHOOP launched its Blood Pressure Insights feature last year, the FDA classified it as an unregistered medical device. The issue wasn't that the band measures pulse waves—plenty of wearables do that. The problem was how WHOOP presented the results to users.

The original version showed specific systolic and diastolic blood pressure values. The FDA classifies that as diagnostic output, which requires approval (clearance) as a Class II medical device. WHOOP didn't have that clearance.

The warning letter from fall 2025 was straightforward: either go through the regulatory process or redesign the feature so it doesn't fall under the medical device category.

What Exactly Did WHOOP Change?

WHOOP chose the second path—redesigning the feature. According to available information, there were three key changes:

1. No specific mmHg values. Instead of "128/82," users now see trend categories—whether their readings fall in normal, elevated, or high ranges. It's similar to how WHOOP displays recovery: not a raw HRV number, but a contextualized view.

2. Explicit disclaimers. The feature now clearly states it's not a clinical measurement and shouldn't replace a doctor's visit. That sounds obvious, but the original version didn't make this prominent enough.

3. Function renamed. "Blood Pressure Insights" became the more general "cardiovascular trend"—which the FDA treats differently than something with "blood pressure" in the name.

Result: The FDA agreed the redesigned feature no longer falls under medical device regulation, and closed the warning letter.

Why This Isn't Just a Paperwork Win

This case is interesting for the entire wearables market. It shows exactly where the line sits between "wellness device" and "medical device"—and that line is thinner than most people think.

It's not about the hardware. WHOOP's wrist sensor didn't change. The optical PPG sensor still measures the same pulse wave. What changed was the software and how data is presented. And that was enough to move the product from one regulatory category to another.

For WHOOP, this has practical implications: they didn't have to go through the 510(k) clearance process, which takes months to years and costs hundreds of thousands of dollars. But they also gave up the ability to show users specific blood pressure numbers.

What This Means for US Users

If you're wearing WHOOP in the US, this story affects you in two ways.

First: the blood pressure feature gets here faster. If WHOOP had to go through full FDA approval (and then similar processes in other regions), we'd be waiting until 2028 or later. As a wellness feature with no diagnostic claims, it can roll out globally much sooner. WHOOP hasn't announced an exact US timeline yet, but the regulatory barrier is now significantly lower.

Second: you won't get specific numbers. If you were hoping WHOOP would replace your blood pressure cuff, that's not happening. You'll see trends and ranges, not values. For most of us—amateur athletes who want to know if something major is shifting—that's enough. If you have diagnosed hypertension, a $30 home blood pressure monitor is still your tool. And honestly, it should be.

Heart Screener and What's Next

This FDA decision sets a precedent for other features too. WHOOP plans to expand Heart Screener—its atrial fibrillation detection feature—to more regions. That one already has FDA clearance (unlike blood pressure, where WHOOP sidestepped approval by changing how it presents data).

For Heart Screener in the EU, stricter MDR (Medical Device Regulation) rules apply. WHOOP will need to work with a notified body, a process independent of what happens in the US. But the fact that the company found a quick compromise with the FDA without litigation is a good sign. It shows WHOOP takes regulation seriously and can adapt—not just fight.

My Take

I've been following this case since the first warning letter, and I have to say—WHOOP handled it pragmatically. Not ideally, but pragmatically. We lost specific numbers, we gained a feature that will actually reach your wrist. And honestly, a trend-based view of blood pressure from an optical sensor on your wrist is probably more useful than a pseudo-precise number I couldn't fully trust anyway.

Once the feature shows up in my app, I'll test it against my home blood pressure monitor and write about how those trends hold up in practice. For now, it's a solid step in the right direction.