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FDA vs. Whoop, Site Neutrality, and CHOP Gets CHIPPER
July 21, 2025
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Together with
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“AI is garbage in, garbage out, gold in, gold out. Not everything is about coming up with a super nerdy algorithm.”
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OpenEvidence CEO Daniel Nadler
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The FDA fired off a warning letter to wearable company Whoop for promoting its blood pressure feature without getting clearance, which quickly reignited the debate on whether wellness claims should be regulated as medical devices.
Whoop’s wristbands pack a punch. The just-released WHOOP MG tracks everything from sleep and heart strain to AFib and Blood Pressure Insights (BPI) – the new feature that landed them in the hot seat.
- BPI delivers daily systolic and diastolic blood pressure estimates by measuring heart rate variability during sleep, allowing users to capture “medical-grade insights” related to their recovery and stress levels.
- The FDA believes that makes the WHOOP MG a medical device subject to regulatory review, because it provides “a measurement or estimation of a user’s blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension.”
Whoop respectfully disagrees. CEO Will Ahmed took to social media to argue that BPI is strictly a wellness feature because it doesn’t diagnose a condition and is clearly labeled not for medical use.
- The 21st Century Cures Act states that “functions intended to promote a healthy lifestyle – and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease – are excluded from the definition of a medical device.”
- Ahmed makes the case that BPI fits that definition, and said that Whoop won’t be backing down from “misguided” overreach that undermines innovation.
Where should regulators draw the line? The carve-out for wellness features is explicitly based on intended use, and most people seem to agree that BPI meets that standard.
- Law firm Hyman, Phelps & McNamara shared that the warning letter breaks the FDA’s precedent for intended use, and that the agency already has separate product codes for “general wellness” and “medical” versions of pulse oximeters and heart rate monitors.
- The FDA’s stance is that blood pressure estimates are high-risk because an error could have major consequences for the user, placing them firmly outside the “general wellness” bucket.
The Takeaway
The regulation versus innovation debate is the gift that keeps on giving, and Whoop’s response will make it obvious how far they’re willing to go to “not let regulatory overreach dictate how people access their own health data.”
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Kennedy Community Health Finds RPM Success With Withings
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- CMS Leans In On Site Neutrality: CMS proposed a 2.4% rate increase for hospital outpatient services and ambulatory surgical centers in 2026, as well as a range of other policies to support site neutrality. The proposal included new billing codes for remote patient monitoring and digital therapeutics, with CMS making it clear that it’s continuing the push to unite reimbursement across care settings. The AHA wasn’t thrilled with the changes, mainly because equalizing reimbursement regardless of location puts pressure on hospitals that have higher fixed costs and tighter regulatory requirements.
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- The First OTC Cuffless Monitor: Swiss blood pressure monitoring startup Aktiia received FDA 510(k) clearance for over-the-counter use of its Hilo Band wrist wearable, making it the first cuffless BP monitor to be made available without a prescription in the U.S. The G0 Blood Pressure Monitoring System will be available to American consumers in 2026, following a successful deployment in Europe where it’s already been used by over 130k patients.
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- M7 Lands $10M: M7 Health landed $10M of Series A funding to advance its end-to-end platform for nurse scheduling, staffing, and communication. The M7 platform aligns the needs of nurses with the realities of hospital operations to create balanced schedules that reduce administrative burden, and the Series A will help double down on AI-powered scheduling capabilities. M7 is already being used by 13k healthcare professionals across more than 60 hospitals, and it’s on track to double that footprint by the end of the year.
- Patients Suspicious of Doctors Using AI: A new survey in JAMA Network Open showed that patients view doctors who use AI as less competent, less trustworthy, and less empathetic. The poll of 1.3k U.S. adults assessed attitudes towards doctors who use AI across three use cases: diagnostic, administrative, and therapeutic. For diagnostic use, respondents scored physicians using AI as less competent on a five-point scale compared to doctors who didn’t (3.66 vs. 3.85). Patients were also less willing to make appointments with diagnostic AI-using physicians (3.16 vs. 3.61).
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