The FDA Says You Can't Know Your Blood Pressure Until You're Sick Enough
How America's health regulator accidentally made prevention illegal—and what could actually fix it
July 15, 2025. Will Ahmed opens an FDA warning letter that perfectly captures everything broken about American healthcare regulation.
Whoop had added blood pressure tracking to their fitness wearable. Once a day, during sleep, the device estimates BP from the same sensor that tracks heart rate. Not diagnosing anything. Not prescribing medication. Just showing trends—like it already does for heart rate variability and respiratory rate.
FDA’s response: Stop. This is an unregistered medical device. Blood pressure measurement is “inherently linked” to diagnosing hypertension. You need full medical device approval.
Here’s what makes this absurd: 664,470 Americans died from hypertension-related causes in 2023. The economic burden is $219 billion annually. Hypertension kills because people don’t know they have it until it’s too late—heart attack, stroke, kidney failure.
But when a company tries to help people track their BP before they need an ambulance? FDA says that’s too dangerous.
Meanwhile, you can buy cigarettes at any gas station.
I run a preventive health company. Our mission is helping people understand their bodies before they get sick. Here’s what the Whoop decision means for us: We receive blood pressure data from FDA-cleared devices that users connect to our app. When I see patterns that—according to published American Heart Association guidelines—suggest someone should talk to their doctor, FDA’s current stance says I should stay silent. Even if the clinical evidence is clear. Even if saying nothing means someone misses early intervention.
The message: until someone is diagnosed with disease, helping them understand health risks is too dangerous.
This isn’t about Whoop. It’s about whether we’re allowed to stay healthy—or have to wait until we’re sick before technology can help us.
What Actually Happened
Whoop built the blood pressure feature carefully—one daily reading during sleep using the same optical sensor that tracks heart rate in every fitness wearable. They positioned it as wellness: understanding how your body responds to sleep, stress, training.
FDA pointed to “evidence” of medical intent: One sentence on their website (”Elevated blood pressure can be a sign of poor sleep”). Color-coded indicators showing green, yellow, orange zones. The association itself—blood pressure is “inherently linked to diagnosis,” so any BP feature automatically becomes a medical device.
Will Ahmed’s public response: “We respectfully disagree. This is wellness, like tracking breathing rate or HRV. We’re helping people understand their bodies, not diagnosing disease.”
Here’s the paradox. Every fitness tracker measures heart rate—no FDA approval needed, even though abnormal heart rate signals cardiac problems. HRV tracking? Standard feature, no approval. Respiratory rate? Unregulated, even though breathing patterns indicate disease. Blood oxygen (SpO2)? Wellness pulse oximeters exist for athletes and pilots without FDA clearance, even though oxygen saturation directly links to lung disease.
Blood pressure trends? Stop everything. What if someone sees a red number and panics? What if they—horror of horrors—go talk to their doctor? We can’t possibly show people information about their own bodies without spending 18 months and $1.5M proving this won’t cause mass hysteria. The streets will run with anxious patients! Emergency rooms will overflow! Society will collapse!
(Or, you know, people will have a conversation with their doctor about prevention. But that’s apparently too dangerous to allow.)
The distinction isn’t based on risk or clinical evidence. It’s historical—BP has traditionally been measured in clinical settings, so any BP feature triggers the full medical device pathway. Even when all you’re doing is showing someone information about their own body.
Why This Matters (And Why Most Startups Can’t Fight Back)
Whoop Can Afford This. We Can’t.
Whoop can afford this fight—they’ve raised over $400M. Most preventive health startups? We can’t. And it’s not about the FDA filing fee ($24K, or $6K for small businesses). That’s the visible cost.
The real killer is everything else. Software validation, cybersecurity testing, usability studies, small clinical trials, quality management system setup, regulatory consultants—you’re looking at $500K to $1.5M just to get permission to launch. Timeline: 12-24 months minimum.
Speed Death (And Why Prevention Is Different)
But here’s what actually kills you: speed death. Modern software companies ship updates weekly, sometimes daily. We A/B test, iterate based on user feedback, improve algorithms as we learn. FDA approval means freezing your product for two years. No updates. No improvements. No learning from real users. You submit Version 1.0 and pray it works.
And here’s the cruel irony: preventive health technology lives or dies on behavioral change and patient engagement. 90% of users abandon health apps within the first week. We need to iterate constantly—test messaging, refine UX, personalize coaching, optimize timing—far more than any medical device ever will. A diabetic with a glucose monitor isn’t going anywhere; they need it. But someone who’s healthy? They’ll delete your app the moment it becomes annoying or irrelevant.
Freezing a preventive health product for two years isn’t just inconvenient. It’s guaranteed failure. By the time you launch, your engagement mechanisms are obsolete. You can’t adapt. You can’t improve. You’re stuck with whatever retention rate you had at submission—which, statistically, means you’ve already lost 90% of users.
After approval? Any meaningful change requires resubmission. Algorithm tweak to improve engagement? Resubmit. UI change affecting how people interpret health information? Resubmit. You become a bad product company because you can’t be a good one.
FDA’s framework was built for devices that treat diagnosed patients—people who are already motivated by disease. But prevention isn’t like that. Prevention is competing with Netflix, Instagram, and every other app on someone’s phone. Without constant iteration, you’re dead.
The ROI Black Hole
Then there’s the ROI black hole. FDA approval doesn’t guarantee revenue. Medicare doesn’t automatically cover FDA-approved devices—that’s a separate battle. The MCIT rule that was supposed to create a pathway? Repealed in 2021. Commercial insurers make their own coverage decisions. You need to negotiate with dozens of payers separately, which takes years.
So investors see: $1M+ spend, 18+ months delay, zero guarantee of market access. Why fund that when they could invest in B2B SaaS with predictable economics?
The AI Double Standard
Meanwhile—and this is what makes it maddening—FDA has been fast-tracking AI diagnostic tools. AI chatbots for clinical decisions? Getting approved. Algorithms that analyze medical images? Breakthrough device programs. These are literal black boxes—nobody can fully explain how a neural network decides—but FDA figured out how to evaluate them.
Whoop’s transparent BP algorithm based on established science? Blocked.
Why We Can’t Just Accept This
We started Welltory because people deserve to understand their bodies before they get sick. We want to help people see patterns, take action early, when lifestyle changes can still prevent chronic disease. We don’t even have a Series A—we’re bootstrapped, financed by our users. We can’t freeze our product for 18 months. We can’t spend $1.5M we don’t have on regulatory approval for showing someone information about their own body.
Here’s the thing: any startup in preventive health would do almost anything for clear market access. We want oversight. We want safety standards. We want accountability.
What FDA offers is uncertainty, massive costs, indefinite timelines, and no guarantee of market access even if you survive the process.
That’s not regulation. That’s paralysis.
The Lies We Need to Stop Believing
Before solutions, let’s kill the premises FDA’s policy is built on.
Lie #1: “Better not to scare people”
The implicit logic: people see elevated BP, they panic, unnecessary ER visits, healthcare system overwhelmed.
The actual numbers: Between 2006-2015, about 600K-900K Americans went to emergency departments primarily for elevated blood pressure. ACEP guidelines are explicit—asymptomatic elevated BP doesn’t warrant emergency treatment. Route to primary care for proper monitoring.
Despite clear guidelines, studies show 80% of these patients get diagnostic testing in the ED and over 30% receive medications. Significant overutilization. Many visits could have been handled in primary care.
Even assuming worst case—all of these are “unnecessary panic” (they’re not; some have real complications)—at $750 per visit, that’s roughly $450-675 million annually.
Compare to uncontrolled hypertension: $219 billion annually plus 664,470 deaths.
The ratio is 300:1. For every dollar spent on anxiety visits, we lose $300 to late detection and poor control.
AHA and ACEP recommend the same solution: asymptomatic elevated readings should trigger home monitoring or ambulatory BP to confirm, not panic. The answer isn’t hiding information—it’s smart navigation and education.
The real public health problem isn’t people learning about risks “too early.” It’s people learning too late, in the ICU with a stroke.
Lie #2: “Showing clinical guidelines = making a diagnosis”
The American Heart Association publishes BP guidelines publicly. Anyone can Google them. They define stages with color zones: Normal (<120/80), Elevated, Stage 1 Hypertension, Stage 2. These guidelines are everywhere.
People already use unverified AI chatbots to interpret health data. But if a legitimate wellness app references the same AHA guidelines with clear disclaimers? FDA calls it “making a diagnosis.”
Because of formatting. Because of colors.
We’re forcing people to figure out health information alone—with Google, random websites, AI that may or may not be accurate—while preventing legitimate companies from sharing verified, publicly available clinical knowledge.
Lie #3: “No proven benefit = should be banned”
FDA’s default: prove clinical benefit to exist in market.
But some health benefits take years to manifest. Mindset shifts, habit formation, lifestyle changes—these are long arcs. Preventing something that didn’t happen is invisible.
Even without clinically significant biomarker improvements, if there’s no harm and people find value, why ban it? Maybe the benefit is psychological—reduced anxiety through understanding. Maybe it’s behavioral—better doctor conversations. Maybe it’s long-term prevention that won’t show in a 6-month trial.
“We don’t know yet” isn’t the same as “this must be forbidden.”
Better approach: Prove no harm first (safety testing, monitoring). Show benefit if you can (surrogate markers, behavior change). If no harm plus user value plus reasonable mechanism, let it exist.
Two tiers: Green (proven benefit = mandatory coverage). Yellow (no demonstrated harm = allowed in market, optional coverage).
Lie #4: “Personalization can’t be tested”
FDA wants proof things “work for everyone.” But personalized medicine means interventions work differently for different people based on genetics, environment, psychology, preferences. That’s the point.
“Show me your one-size-fits-all clinical trial” is the wrong question for personalized prevention.
Right questions: Does it fail catastrophically for any populations? Can you monitor real-world outcomes? Does performance degrade for specific groups? Are there adverse events?
You can’t predict every scenario for adaptive systems. Stop pretending you can. Test safety on edge cases and monitor continuously in real life.
These lies share a foundation: FDA treats “health” as synonymous with “disease.” If you’re tracking metrics related to diagnosed conditions, you’re doing medicine. If you’re helping people understand their bodies before diagnosis, you’re in regulatory limbo.
This is backwards. Health doesn’t begin when disease is diagnosed. Health is everything that happens before you get sick—and technology that helps people stay healthy isn’t medicine.
It’s prevention. And prevention should be a right, not a regulatory nightmare.
A System That Actually Works
Let’s try to find a solution without compromise.
Startups need fast market access, clear path to coverage, ability to iterate. FDA needs safety assurance and accountability. Payers need cost-effectiveness proof without funding unproven tech. Patients need access to innovation plus protection from harm. Doctors need reliable tools with no liability risk.
Current system gives none of them what they need. FDA gets false safety by blocking useful prevention. Payers get chaos with no standardized evidence. Startups die. Patients develop preventable disease.
Here’s a system that actually works. And honestly? There are no unsolvable problems here. Just lack of will.
Think pipeline, not wall. Current FDA is binary—either “approved medical device” or “unregulated wellness.” Instead, products should flow through stages: Classification → Safety Clearance → Market Access → Evidence Generation → Mandatory Coverage → Continuous Monitoring.
The classification piece: Not all health claims carry the same risk. Showing someone their blood pressure trend with AHA guidelines isn’t the same as diagnosing hypertension or prescribing medication. Create five levels from pure information (lowest risk, fastest approval) to actual diagnosis and treatment (highest risk, full FDA pathway). Whoop’s BP trends would be Information or Behavioral Coaching level. Quick safety tests, clear disclaimers, no million-dollar approval process.
The safety piece: Stop requiring custom clinical trials for each product. FDA publishes standard test scenarios—like crash tests for cars. Sensor accuracy across skin tones? Check. Interface clarity? Check. Works for edge cases? Check. Companies run tests, submit results, FDA spot-checks. Updates yearly based on real failures. This is cheaper, standardized, focused on actual safety risks instead of hypothetical ones.
The market access piece: Create a voluntary public insurance option—Innovation Medicare—that auto-covers preventive tech passing safety clearance. The key: representative sampling as core principle. Not just healthy early adopters. Statistical algorithm ensures diverse enrollment across geography, demographics, health status. Members consent to data sharing. Goal: 1-2M representative group.
For startups, this IS your evidence pipeline. Real users, real data, immediate revenue. No negotiating with 50 insurers before you have proof. Technology enables this now—FHIR APIs, remote monitoring, standardized outcomes, machine learning for analysis.
The accountability piece: Build a transparency registry. When any product tells someone “go see a doctor,” it automatically pings a public database with de-identified data. Follow-up tracking shows whether referrals were appropriate. Calculate positive predictive value, false alarm rate, demographic equity for each product. Public scorecard after 6 months. Green score (high accuracy, low false alarms) versus Red (poor performance, under review).
This isn’t about hiding information. It’s about making quality visible. Good products prove themselves. Bad products get exposed fast. Doctors know which alerts to trust. Patients get transparency.
The coverage piece: Two tiers. Yellow tier (market access): pass safety clearance, allowed to sell, Innovation Medicare covers at 50%, private payers can choose. Green tier (mandatory coverage): after 12-24 months showing demonstrated benefit, cost-effectiveness, good registry scores, all payers must cover at standard rate.
Clear path: deliver value, earn mandatory coverage. Don’t deliver, market filters you out.
How it works together: Startup classifies product by claim level, gets safety clearance in weeks to months for $10-150K depending on level, launches immediately via Innovation Medicare, generates real-world evidence while iterating freely within same level, earns Green tier with proven value after 1-2 years, gets mandatory coverage everywhere.
For Whoop’s BP tool: classify as Behavioral/Navigation level, 8-12 weeks safety testing costing ~$100K, launch immediately, iterate based on user engagement (because prevention requires it), show reduced uncontrolled hypertension after 18 months, earn mandatory coverage. Total: ~2 years, ~$500K versus current $1.5M+ with no guarantee.
This is MORE accountability than current system—continuous monitoring, public scorecards, rapid removal of bad products. This is MORE evidence-based—real outcomes in representative populations over time. This is SMARTER risk management—proportional oversight, focus on actual harms, quick problem identification.
Each piece enables the others. Remove one, system weakens. Together, they create a functioning ecosystem where good products win, bad products fail, startups have predictable pathways, payers fund what works, patients get safe prevention access.
Who wins: Startups delivering value. Patients getting prevention. Payers funding what works. FDA achieving real safety.
Who loses: Startups not delivering (good). Incumbents hiding behind barriers (also good).
That’s how policy should work.
Why the System Stays Broken (And Who Could Fix It)
Short-term incentives beat long-term value. Incumbent medical device companies benefit from barriers that protect market position. Fee-for-service healthcare profits from treatment, not prevention. Pharma makes money from chronic disease management.
Meanwhile patients develop preventable disease, startups can’t compete, payers watch long-term costs explode, employers deal with sick workforces.
Here’s the irony: payers actually want prevention—it saves money long-term. Employers want healthy workers. Patients want to avoid getting sick. The misalignment is temporal. Quarterly profits versus lifetime health.
Forcing functions that could change this: Medicare Advantage plans required to demonstrate prevention metrics. Employers demanding preventive tech coverage in insurance contracts. State Medicaid experiments. Value-based care contracts that penalize poor prevention outcomes.
The Innovation Medicare Plan solves the temporal mismatch by aligning multi-year evidence collection with long-term value creation.
The FDA Could Actually Lead This
This isn’t fantasy. FDA has precedent.
21st Century Cures Act (2016) carved out low-risk clinical decision support software. Created pathway for real-world evidence in drug approvals. Breakthrough Devices Program fast-tracks high-value innovations with flexible evidence requirements. Patient-Reported Outcomes already used in approvals—acknowledging patient experience matters beyond clinical measurements.
When evidence showed pulse oximeters were less accurate on darker skin, FDA tightened requirements: diverse testing populations, better labeling, stricter performance standards. This is good regulation—targeted, evidence-based, addresses real demonstrated harm.
Apply same thinking to preventive wearables: Don’t ban BP trends because “someone might panic.” Do require accuracy standards, demographic testing, clear disclaimers. Monitor real-world harms, adjust based on data.
The tools exist. The precedents exist. What’s needed is will.
Pressure building: Former FDA Commissioner Scott Gottlieb publicly criticizing current approach (”Recent FDA policy puts a ceiling on functionality of new AI tools and forces developers to gut product capabilities”). Industry pushback from Whoop going public. International competition—Europe’s DiGA program, UK’s NICE pathways, China moving faster. Bipartisan political interest in prevention and innovation.
The ask: Implement risk-based classification. Launch transparency registry. Partner with CMS on Innovation Medicare. Develop standard safety test suites.
Not “deregulate everything.” Smart, risk-based, evidence-driven prevention policy.
The Choice
Without change, here’s what continues: Innovation moves to Europe, UK, China—countries with clearer pathways. American companies develop overseas first. Chronic disease burden grows while prevention tech that could help stays locked out. Wealthy people pay out-of-pocket for prevention. Everyone else waits until they’re sick enough for insurance to cover treatment. Health equity becomes a class divide.
Only companies that can afford multi-million-dollar approvals survive. The Googles and Apples, not the startups that need to move fast. Regulatory capture deepens.
Here’s my provocation: If we applied FDA’s Whoop logic consistently, bathroom scales would be medical devices (weight linked to obesity). Thermometers would need approval (fever indicates infection). Fitness trackers couldn’t show steps (sedentary lifestyle causes disease).
Obviously absurd. So why is blood pressure different?
It isn’t. The distinction is historical, arbitrary, and harmful.
I spent one evening thinking through this problem. One evening. Not claiming I’ve designed the perfect system—I haven’t. But that evening convinced me of something important: real solutions exist.
Not compromises. Life taught me compromises always produce shit. Half-measures that sort of work for nobody. What we need—and what’s actually possible—is a real solution that accounts for everyone’s legitimate interests. Money’s interests. People’s interests. Innovation’s interests. Safety’s interests.
They’re not incompatible. They just require actually thinking about the problem instead of defending the status quo.
FDA could lead this. They have precedent (Cures Act, RWE frameworks, Breakthrough Devices). They have tools. They have pressure building from all sides. They could make prevention innovation possible in America.
Or not. Either way, those of us working on helping people stay healthy aren’t stopping. We’ll navigate the gray zones, find creative positioning, iterate until we figure it out. The mission is too important to abandon because regulation is hard.
But here’s what I know for sure: prevention shouldn’t require regulatory gymnastics. It shouldn’t be reserved for companies rich enough to fight. It should be the foundation of healthcare.
Fingers crossed!