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The Verge
a day ago
- Health
- The Verge
The dangerously blurry line between wellness and medical tech
Few things scratch my brain like a good beef. Kendrick vs. Drake. Justin Baldoni vs. Blake Lively. On my beat, it's usually two companies fighting over health tech patents. So-and-so copied a feature from so-and-so. The latest dispute on my radar is all about semantics. More specifically, the exact meaning of wellness. Let me catch you up. On July 15th, the Food and Drug Administration (FDA) sent Whoop a letter. In it, the FDA declared that Whoop — maker of a niche fitness tracker favored by elite athletes — had crossed a line. Its new Blood Pressure Insights feature, the regulator said, was being marketed to customers without undergoing the proper clearance process. In response, Whoop pulled out the W word: wellness. In the world of health and wearable tech, 'wellness' is sort of like a 'get out of jail free' card. Some advanced health features, like EKGs and atrial fibrillation notifications, require regulatory clearance before consumers can use them. These features could be interpreted as diagnostic in nature or prompt a person to make a medical decision. Others, like step tracking and blood oxygen measurements, don't require FDA oversight at all. They're simply meant to make living a healthy life easier by helping you visualize certain measurable markers. Those features fall under the wellness umbrella. They're 'just for fun.' Whoop's Blood Pressure Insights feature, however, lies in murkier territory. The way Whoop's feature works is that a user takes readings with a regular blood pressure cuff for calibration. Once that process is complete, Whoop says its tracker uses metrics like 'heart rate, heart rate variability, and blood flow patterns during sleep' to give an estimate of a person's systolic and diastolic blood pressure each morning. The FDA contends that 'providing blood pressure estimation is not a low-risk function' and that a blood pressure estimate inherently implies you're diagnosing hypo- or hypertension. In a statement, Whoop says it 'respectfully disagree[s]' and that this particular feature is more akin to tracking your sleeping respiratory rate. Under the wellness umbrella, Whoop argues it's able to bring an innovative feature to the masses more quickly. Whoop and the FDA both have points. It's not a stretch to think that a user may get a few 'high' blood pressure estimates, assume they have high blood pressure, and make health decisions informed by that assumption. At the same time, it's clearly labeled as a beta feature, and similar 'diagnostic adjacent' features are available without FDA regulation. I've lost count of how many sleep trackers claim to track 'breathing disturbances.' That may not be explicitly marketed as a sleep apnea detection metric (that would require FDA clearance), but that's semantics. The obvious reason to include it is to flag when a person might want to check themselves for sleep apnea. The crux of it all is identifying high- and low-risk features for causing harm. Many cases are clear-cut. Natural Cycles, for example, is a period tracking app that claims you can use it as digital contraception using temperature data from wearables like the Oura Ring. It's obvious that a regulatory body should vet a high-stakes feature like that. On the flip side, Samsung's new Antioxidant Index feature for its Galaxy Watch 8 is a silly metric that tells you whether you've eaten enough fruits and veggies. Even if it's inaccurate as hell (I was able to fool it by scanning a Cheez-It), it's not likely to harm your health. Where the FDA's current process falls short is the increasing number of features that lie somewhere in the middle. Take the Oura Ring. A friend just asked me whether they should get one based on a TikTok video. In said video, celebrity DJ Dillon Francis says the main reason he has an Oura Ring is because it predicts when he's getting sick. This is the Symptom Radar feature, which, in simple terms, flags when you might be getting sick — and it's based on real clinical research conducted during the COVID-19 pandemic. It sounds diagnostic, which requires FDA clearance. But it's not. It's considered a wellness feature because it doesn't tell you what you're falling ill with — just that you might be showing 'early signs of a health change.' And while there's a distinct difference between a diagnosis and a heads-up, it can feel awfully similar to a layperson. Also, Whoop isn't the only company exploring blood pressure tech. Samsung has a similar feature that's unavailable in the US, as it hasn't been cleared by the FDA. According to Bloomberg, Apple has also been working on an Apple Watch feature that flags when your blood pressure spikes above your baseline, but it reportedly won't spit out direct readings like a continuous glucose monitor would — possibly to avoid FDA clearance as a 'wellness' feature. Perhaps that means it's time we acknowledge that wellness isn't an innocuous word anymore. Beyond blood pressure, Samsung and Apple are also widely rumored to be working on blood glucose monitoring features, where the stakes for diabetics could be sky-high. If or when those features do become available, it's possible that companies will adjust how they work to more broadly fit under a wellness label. For instance, instead of glucose readings, you get a trend line or score. I'm skeptical of the average person being able to discern the nuance when even seasoned tech journalists sometimes struggle with the correct verbiage. Maybe it seems silly to sound the alarm over semantics. But as politicians advocate for greater wearable adoption, the stakes have never been higher. In a better, ideal world, companies would abolish phrases like 'clinically proven' or 'medical grade' from marketing. The FDA would figure out a clearer framework for the design of a wellness feature versus a medical one. But we don't live in an ideal world — and that means it's up to the consumer to know the difference. Frankly, that's not going so well. Perhaps that means it's time we acknowledge that wellness isn't an innocuous word anymore. Posts from this author will be added to your daily email digest and your homepage feed. See All by Victoria Song Posts from this topic will be added to your daily email digest and your homepage feed. See All Analysis Posts from this topic will be added to your daily email digest and your homepage feed. See All Features Posts from this topic will be added to your daily email digest and your homepage feed. See All Fitness Posts from this topic will be added to your daily email digest and your homepage feed. See All Gadgets Posts from this topic will be added to your daily email digest and your homepage feed. 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CNBC
15-07-2025
- Health
- CNBC
Whoop says FDA is 'overstepping its authority' with warning about blood pressure feature
The U.S. Food and Drug Administration on Tuesday published a warning letter addressed to the wrist wearable company Whoop, alleging it is marketing a new blood pressure feature without proper approvals. The letter centers around Whoop's Blood Pressure Insights (BPI) feature, which the company introduced alongside its latest hardware launch in May. Whoop said its BPI feature uses blood pressure information to offer performance and wellness insights that inform consumers and improve athletic performance. But the FDA said Tuesday that Whoop's BPI feature is intended to diagnose, cure, treat or prevent disease — a key distinction that would reclassify the wellness tracker as a "medical device" that has to undergo a rigorous testing and approval processes. "Providing blood pressure estimation is not a low-risk function," the FDA said in the letter. "An erroneously low or high blood pressure reading can have significant consequences for the user." A Whoop spokesperson said the company's system offers only a single daily estimated range and midpoint, which distinguishes it from medical blood pressure devices used for diagnosis or management of high blood pressure. Whoop users who purchase the $359 "Whoop Life" subscription tier can use the BPI feature to get daily insights about their blood pressure, including estimated systolic and diastolic ranges, according to the company. Whoop also requires users to log three traditional cuff-readings to act as a baseline in order to unlock the BPI feature. Additionally, the spokesperson said the BPI data is not unlike other wellness metrics that the company deals with. Just as heart rate variability and respiratory rate can have medical uses, the spokesperson said, they are permitted in a wellness context too. "We believe the agency is overstepping its authority in this case by attempting to regulate a non-medical wellness feature as a medical device," the Whoop spokesperson said. High blood pressure, also called hypertension, is the number one risk factor for heart attacks, strokes and other types of cardiovascular disease, according to Dr. Ian Kronish, an internist and co-director of Columbia University's Hypertension Center. Kronish told CNBC that wearables like Whoop are a big emerging topic of conversation among hypertension experts, in part because there's "concern that these devices are not yet proven to be accurate." If patients don't get accurate blood pressure readings, they can't make informed decisions about the care they need. At the same time, Kronish said wearables like Whoop present a "big opportunity" for patients to take more control over their health, and that many professionals are excited to work with these tools. Understandably, it can be confusing for consumers to navigate. Kronish encouraged patients to talk with their doctor about how they should use wearables like Whoop. "It's really great to hear that the FDA is getting more involved around informing consumers," Kronish said. Whoop is not the only wearable manufacturer that's exploring blood pressure monitoring. Omron and Garmin both offer medical blood pressure monitoring with on-demand readings that fall under FDA regulation. Samsung also offers blood-pressure-reading technology, but it is not available in the U.S. market. Apple has also been teasing a blood pressure sensor for its watches, but has not been able to deliver. In 2024, the tech giant received FDA approval for its sleep apnea detection feature. Whoop has previously received FDA clearance for its ECG feature, which is used to record and analyze a heart's electrical activity to detect potential irregularities in rhythm. But when it comes to blood pressure, Whoop believes the FDA's perspective is antiquated. "We do not believe blood pressure should be considered any more or less sensitive than other physiological metrics like heart rate and respiratory rate," a spokesperson said. "It appears that the FDA's concerns may stem from outdated assumptions about blood pressure being strictly a clinical domain and inherently associated with a medical diagnosis." The FDA said Whoop could be subject to regulatory actions like seizure, injunction, and civil money penalties if it fails to address the violations that the agency identified in its letter. Whoop has 15 business days to respond with steps the company has taken to address the violations, as well as how it will prevent similar issues from happening again. "Even accounting for BPI's disclaimers, they do not change this conclusion, because they are insufficient to outweigh the fact that the product is, by design, intended to provide a blood pressure estimation that is inherently associated with the diagnosis of a disease or condition," the FDA said.
