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The logo for the Food and Drug Administration is seen ahead of a news conference on removing synthetic dyes from America’s food supply, at the Health and Human Services Headquarters in Washington, DC on April 22, 2025.

Nathan Posner | Anadolu | Getty Images

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.

FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009. 

Jason Reed | Reuters

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.

WATCH: Watch CNBC’s full interview with FDA commissioner Dr. Marty Makary

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency’s Commissioner Marty Makary told CNBC on Friday. 

The FDA in June announced a national priority voucher plan that aims to cut drug review times to one-to-two months for companies it says are supporting “U.S. national interests.” But previous announcements on the voucher program did not explicitly mention making drugs more affordable as a criterion. 

“We are including the affordability of drugs as a national priority,” Makary told CNBC.

Lowering drug prices is a key goal of the Trump administration, which is facing a tough balancing act as it threatens to impose up to 200% tariffs on pharmaceuticals imported into the U.S. in a bid to reshore drug manufacturing.

Commissioner of the Food and Drugs Administration Marty Makary speaks at a news conference on removing synthetic dyes from America’s food supply, at the Health and Human Services Headquarters in Washington, DC on April 22, 2025.

Nathan Posner | Anadolu | Getty Images

Makary added that President Donald Trump is “very adamant that he would lower drug prices for Americans, and he doesn’t like it that Americans are getting ripped off with drugs that are two, five, 10 times higher” in the U.S. compared to other developed countries.

But it is unclear how the Trump administration will consider affordability when reviewing a drug, as prices for a product’s launch are usually determined after an approval in the U.S.

The FDA’s website currently outlines four examples of “national priorities” that will be used to determine which companies will get a voucher under the new program. That includes addressing a health crisis in the U.S., delivering “more innovative cures” to Americans, addressing unmet public health needs and “increasing domestic drug manufacturing as a national security issue.” 

Drug affordability may have been included previously, according to a Wall Street Journal report in June. 

A spokesperson for the Department of Health and Human Services confirmed that the FDA will consider drug affordability for the program, adding the criteria aren’t limited to earlier examples.

When asked to provide examples of a health crisis that companies can meet with their drugs, Makary said he wants to see a cure for Type 1 diabetes, more treatments for neurodegenerative diseases and a universal flu shot “so we don’t have to try to guess which strain is coming.” 

He also said he wants to see more treatments for stage 4 cancer, or when the disease has spread from its original site to distant parts of the body. 

“We have a committee that’s set up that will determine which products and companies will get these vouchers as part of a pilot,” Makary said. “But we’ve got to try new things. We’ve got to ask ourselves, why does it take so long to come to market? And we want to see more cures and meaningful treatments for Americans.”

The FDA will give out new vouchers this year. After a one-year pilot phase, the agency may increase the number of quick approvals it gives to companies.

Some Wall Street analysts have previously said the voucher program could be more effective than tariffs at encouraging drugmakers to bring their manufacturing to the U.S. 

But questions remain about the risks of speeding up drug reviews to as little as 30 days, which is the fastest the FDA has ever done.

Another potential concern is whether the FDA will offer vouchers to political allies of the Trump administration, which could include companies that agency staff would normally scrutinize. 

Biostatistician and epidemiologist Martin Kulldorff, MD, PhD, and Dr. Mina Zadeh, ACIP Executive Secretary, CDC, look on as people present their information to members of the Advisory Committee on Immunization Practices, as the U.S. Centers for Disease Control and Prevention’s (CDC) advisory panel for vaccines convenes, in Atlanta, Georgia, U.S. June 25, 2025.

Megan Varner | Reuters

A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.

A revamped government panel of vaccine advisors with newly appointed immunization skeptics has voted against a mercury-containing shot ingredient that the anti-vaccine movement has long targeted.

The group, called the Advisory Committee on Immunization Practices, or ACIP, voted Thursday to recommend annual single-dose flu vaccines to Americans and against influenza shots containing thimerosal – even though there is no evidence of harm from that preservative. It was the first ACIP meeting since Health and Human Services Secretary Robert F. Kennedy Jr. gutted the panel and stacked it with new members, including several well-known vaccine skeptics. 

The Centers for Disease Control and Prevention still needs to sign off on that recommendation. If the agency does, it would affect roughly 4% to 5% of the U.S. flu vaccine supply. 

The rest of the nation’s flu shots were thimerosal-free during the last season of the virus, according to CDC data. But when it comes to vaccinating an entire country, “small percentages matter,” Dr. Sean O’Leary, an infectious disease expert with the American Academy of Pediatrics, told reporters last week. 

If the few thimerosal-containing flu shots were removed from the market, 

“that would inevitably lead to fewer people being vaccinated, at least in the short term, perhaps longer term, and subsequently more hospitalizations and deaths,” O’Leary said. 

The recommendation also reinforces longstanding, unfounded fears that the substance can lead to developmental disabilities, such as autism. Kennedy’s vaccine skepticism comes full circle with the panel’s vote: A decade before stepping into his current role, he published a book that called for the removal of thimerosal from shots and linked it to developmental disorders. 

“A very common anti-vaccine talking point is around thimerosal, so that’s a very clear strategy to sow distrust in vaccines,” O’Leary said. 

Susana Sanchez, a Nurse Practitioner, administers a flu vaccination to Loisy Barrera at a CVS pharmacy and MinuteClinic on September 10, 2021 in Miami, Florida.

Joe Raedle | Getty Images

Here’s why thimerosal is important. It has been widely used for decades as a preservative to prevent the growth of harmful bacteria in several medicines and vaccines with multiple doses. More than 40 studies over many decades have found no link between thimerosal and developmental delays.

But its use in approved vaccines has dropped sharply as manufacturers have shifted to single-dose packaging for their shots, which doesn’t require preservatives. The Food and Drug Administration around 25 years ago asked manufacturers to remove the substance from childhood vaccines out of an abundance of caution, not because of evidence of harm, according to the CDC. 

“The thought was, well, mercury is a scary sounding word, and let’s just get it out, let’s just make this a non-issue,” O’Learly said. He added that “many studies have shown that it is entirely safe, is not associated with any neurodevelopmental disorders or any other adverse effects.”

Some multi-dose forms of flu vaccines for adults still contain thimerosal, including Sanofi’s Fluzone and two shots from biotech company CSL Seqirus. 

One member of the panel, Dr. Cody Meissner, a professor of pediatrics at the Dartmouth Geisel School of Medicine, said he was worried that discouraging the use of multidose vials could increase the cost of vaccination and limit access for some groups. He also expressed concerns about the message the recommendation would send to other countries where the use of multi-dose flu vaccines is more common.

“That might limit the availability of the influenza vaccine for some people,” he said during the meeting after he voted against restricting thimerosal flu vaccines. 

Before the votes at the meeting, Lyn Redwood, a nurse practitioner who has been involved with anti-vaccine organizations, presented on thimerosal in flu vaccines. Redwood is among the “mercury moms” who pushed for Kennedy to get involved with mercury and children’s health. She has also served for years as president of Children’s Health Defense, the anti-vaccine organization founded by Kennedy.

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

Latest in health-care tech: Arcadia acquired by private equity firm Nordic Capital

Health-care data platform Arcadia has been acquired by the private equity firm Nordic Capital, the companies announced on Tuesday. 

Arcadia turns health-care data into predictive insights that payers and providers can use to help improve care for patients, reduce costs and increase revenue. The company characterized the deal with Nordic Capital as a “strategic partnership” where the firm will become the “majority owner” of Arcadia, according to a release. 

Michael Meucci, Arcadia’s CEO, said working with Nordic Capital will allow Arcadia to continue to improve its customer experience, expand on its artificial intelligence capabilities, explore new M&A opportunities and drive growth in its core segments, including value-based care. 

“It’s hugely validating,” Meucci told CNBC in an interview. “It’s validating that there are large-cap institutional investors who are as committed to transforming us (U.S.?) health care and global health care as we have been.”  

Arcadia and Nordic Capital did not disclose the terms of the acquisition. The deal is expected to close in the second half of the year, though it’s still subject to regulatory approvals. 

Meucci said he’s known the Nordic Capital team for a couple years, and that the firm had been watching Arcadia’s progress as a business. Arcadia is profitable and carried out a successful acquisition last year. Meucci said these milestones helped Nordic Capital feel confident that the company was ready for its next stage of growth. 

Arcadia last raised outside funding in 2023, when it announced $125 million in financing from Vista Credit Partners. Nordic Capital’s acquisition serves as an exit for earlier investors, Arcadia said.

“This partnership aligns seamlessly with Nordic Capital’s investment strategy and Nordic Capital is excited to support Arcadia in its next phase of growth,” Daniel Berglund, partner and co-head of health care at Nordic Capital, said in a statement.

TripleTree served as Nordic Capital’s financial advisor for the transaction, and Lazard advised Arcadia.

“This is just a further reinforcement of our mission, that we have to change the cost of health care,” Meucci said. 

Read the full release here.

Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.