FDA clears Apple’s sleep apnea detection feature for use. Here’s how it works
Tim Cook, chief executive officer of Apple Inc., during an event at Apple Park campus in Cupertino, California, US, on Monday, Sept. 9, 2024. Apple Inc. unveiled a new version of its smartwatch with a bigger screen and the ability to detect sleep apnea, part of an event Monday that will also include the iPhone 16 smartphone. Photographer: David Paul Morris/Bloomberg via Getty Images
Bloomberg | Bloomberg | Getty Images
The U.S. Food and Drug Administration on Monday cleared Apple‘s new sleep apnea detection feature for use, which means it will come to the Apple Watch Series 9, Series 10 and Ultra 2 later this month.
Sleep apnea is a sleep disorder that causes a person’s breathing to repeatedly stop and start throughout the night. The condition affects more than 30 million people in the U.S., but only around 6 million are diagnosed, according to the American Medical Association. If it goes untreated, sleep apnea can cause fatigue and lead to more serious health issues like heart problems, hypertension and Type 2 diabetes.
“We are so excited about the incredible impact this feature can make for the millions of people living with undiagnosed sleep apnea,” Dr. Sumbul Desai, vice president of health at Apple, said in the feature’s launch video.
Apple’s sleep apnea detection feature marks the company’s latest attempt to position its wearables as a cheaper, simpler alternative to many existing health-care tests and devices. And the sleep disorder market could prove to be lucrative.
To get evaluated for sleep apnea, for instance, patients typically participate in an at-home test or an in-lab test where they’re monitored overnight. Prices vary depending on insurance coverage, but the average in-lab test costs $3,000, according to a 2022 study in the Journal of Primary Care & Community Health.
At-home tests are often less expensive, but they can still cost hundreds of dollars. The at-home sleep apnea test from Sleep Doctor costs $189, for example. Apple’s newest watch, the Series 10, starts at $399.
Apple’s sleep apnea detection feature is “potentially a game changer” for patients who have been reluctant to seek out testing, said Dr. David Kuhlmann, a physician who has treated sleep disorders for nearly two decades in Missouri. Kuhlmann also serves on the board of the American Academy of Sleep Medicine, which is a professional society for sleep medicine clinicians.
Kuhlmann said the feature could be especially helpful for patients who sleep alone, and he thinks a lot of people will be surprised to find out they’re showing signs of sleep apnea.
Even so, Kuhlmann said users should approach Apple’s sleep apnea data with some caution, as readings could be erroneous. He said it is unlikely that insurance companies will begin paying for sleep apnea therapies like CPAP machines based on Apple Watch data alone, which is why it is important for patients to follow up with their health-care providers to get an official diagnosis.
“People do need to be diagnosed in order to be treated,” Kuhlmann told CNBC in an interview.
Kuhlmann said the feature will likely cause an increase in visits to health-care providers, which could ultimately reduce costs for the U.S. health-care system overall. Ideally, if patients catch sleep apnea earlier, they can avoid paying for treatments for more serious conditions down the line.
“By finding out that they have these underlying sleep disorders and getting them treated, it could potentially actually help save expenses and help improve quality of life.”
How it works
Apple Watch Series 10 sleep apnea alert.
Apple Inc.
Apple’s sleep apnea detection feature works by analyzing a new metric that the company calls “breathing disturbances.” The Apple Watch identifies breathing disturbances by using an accelerometer to measure movements at the wrist that indicate disruptions to normal breathing patterns.
Users can view their nightly metrics in the Health app, where they’ll be classified as either “elevated” or “not elevated,” i.e., normal. Apple will analyze this breathing disturbance data once a month and notify people if they show “consistent signs” of severe or moderate sleep apnea. Users can view their data over a one-month, six-month or one-year period.
The Apple Watch Series 10 supports an 18-hour battery life, so people who are interested in using this feature will likely need to charge their device during the day.
Apple can also generate a report that users can bring to their doctors to discuss next steps. The report includes three months’ worth of breathing disturbance data as well as some additional information, the company said. Users can access educational materials within the Health app as well.
Apple said that the notification algorithm was developed with “an extensive data set of clinical-grade sleep apnea tests,” and that the feature was validated in a clinical study.
“Now I’m jonesing to get an Apple [Watch] so I can try it out on myself,” Kuhlmann said.
Anne Wojcicki attends the WSJ Magazine Style & Tech Dinner in Atherton, California, on March 15, 2023.
Kelly Sullivan | Getty Images Entertainment | Getty Images
23andMe CEO Anne Wojcicki and New Mountain Capital have submitted a proposal to take the embattled genetic testing company private, according to a Friday filing with the U.S. Securities and Exchange Commission.
Wojcicki and New Mountain have offered to acquire all of 23andMe’s outstanding shares in cash for $2.53 per share, or an equity value of approximately $74.7 million. The company’s stock closed at $2.42 on Friday with a market cap of about $65 million.
The offer comes after a turbulent year for 23andMe, with the stock losing more than 80% of its value in 2024. In January, the company announced plans to explore strategic alternatives, which could include a sale of the company or its assets, a restructuring or a business combination.
23andMe has a special committee of independent directors in place to evaluate potential paths forward. The company appointed three new independent directors to its board in October after all seven of its previous directors abruptly resigned the prior month. The special committee has to approve Wojcicki and New Mountain’s proposal.
“We believe that our Proposal provides compelling value and immediate liquidity to the Company’s public stockholders,” Wojcicki and Matthew Holt, managing director and president of private equity at New Mountain, wrote in a letter to the special committee on Thursday.
Wojcicki previously submitted a proposal to take the company private for 40 cents per share in July, but it was rejected by the special committee, in part because the members said it lacked committed financing and did not provide a premium to the closing price at the time.
Wojcicki and New Mountain are willing to provide secured debt financing to fund 23andMe’s operations through the transaction’s closing, the filing said. New Mountain is based in New York and has $55 billion of assets under management, according to its website.
23andMe declined to comment.
WATCH: The rise and fall of 23andMe
Hims & Hers
Shares of Hims & Hers Health tumbled more than 23% on Friday after the U.S. Food and Drug Administration announced that the shortage of semaglutide injection products has been resolved.
Semaglutide is the active ingredient in Novo Nordisk‘s blockbuster weight loss drug Wegovy and diabetes treatment Ozempic. Those medications are part of a class of drugs called GLP-1s, and demand for the treatments has exploded in recent years. As a result, digital health companies such as Hims & Hers have been prescribing compounded semaglutide as an alternative for patients who are navigating volatile supply hurdles and insurance obstacles.
Compounded drugs are custom-made alternatives to brand-name drugs designed to meet a specific patient’s needs, and compounders are allowed to produce them when brand-name treatments are in shortage. The FDA doesn’t review the safety and efficacy of compounded products.
Hims & Hers began offering compounded semaglutide to patients in May, and it owns compounding pharmacies that produce the medications.
Compounded medications are typically much cheaper than their branded counterparts. Hims & Hers sells compounded semaglutide for less than $200 per month, while Ozempic and Wegovy both cost around $1,000 per month without insurance.
The FDA said Friday that it will start taking action against compounders for violations in the next 60 to 90 days, depending on the type of facility, in order to “avoid unnecessary disruption to patient treatment.”
“Now that the FDA has determined the drug shortage for semaglutide has been resolved, we will continue to offer access to personalized treatments as allowed by law to meet patient needs,” Hims & Hers CEO Andrew Dudum posted Friday on X. “We’re also closely monitoring potential future shortages, as Novo Nordisk stated two weeks ago that it would continue to have ‘capacity limitations’ and ‘expected continued periodic supply constraints and related drug shortage notifications.'”
Him & Hers’ weight loss offerings have been a massive hit with investors. Shares of the company climbed more than 200% last year, and the stock is already up more than 100% this year despite Friday’s move.
Even before it added compounded GLP-1s to its portfolio, the company said in its 2023 fourth-quarter earnings call that it expects its weight loss program to bring in more than $100 million in revenue by the end of 2025.
Despite the turbulent regulatory landscape, Hims & Hers has showed no signs of slowing down.
On Friday, the company announced it has acquired a U.S.-based peptide facility that will “further verticalize the company’s long-term ability to deliver personalized medications.” Hims & Hers will explore advances across metabolic optimization, recovery science, biological resistances, cognitive performance and preventative health through the acquisition, the company said.
That move comes just days after Hims & Hers also bought Trybe Labs, the New Jersey-based at-home lab testing facility. Trybe Labs will allow Hims & Hers to perform at-home blood draws and more comprehensive pretreatment testing.
Hims & Hers did not disclose the terms of either deal.
Technology
Tesla recalls more than 375,000 vehicles in U.S. due to failing power-assisted steering systems
Tesla models Y and 3 are displayed at a Tesla dealership in Corte Madera, California, on Dec. 20, 2024.
Justin Sullivan | Getty Images
Tesla is voluntarily recalling 376,241vehicles in the U.S. to correct an issue with failing power-assisted steering systems, according to records posted to the website of the U.S. National Highway Traffic Safety Administration.
In a safety recall report posted on the NHTSA website, Tesla said the recall includes Model 3 and Model Y vehicles that were manufactured for sale in the U.S. from Feb. 28, 2023, to October 11, 2023, and that were equipped with a certain older software release.
The records said printed circuit boards in the steering systems in affected vehicles could become overstressed, causing the power-assist steering to fail in some cases when a Tesla vehicle rolled to a stop and then accelerated.
When electronic power-assist steering systems fail in a Tesla, drivers need to exert more force to steer their cars, which can increase the risk of a collision.
Tesla told the vehicle safety regulator that it was not aware of any crashes, injuries or deaths related to the power steering failures, and that it was offering an over-the-air software update as a remedy.
The recall follows an earlier related probe and voluntary recall in China concerning the same systems.
President Donald Trump has appointed Tesla CEO Elon Musk to lead a team that is slashing the federal government workforce, and in some cases, regulations and entire agencies. Those cuts already affected the NHTSA, an agency Musk has long seen as standing in the way of some of his ambitions at Tesla.
The regulator has been engaged in a yearslong investigation into safety defects in the systems that Tesla markets currently as its Autopilot and Full Self-Driving (Supervised) options. The features do not make Tesla cars into robotaxis. They require a human driver ready to steer or brake at any time.
The Washington Post reported on Thursday that Musk’s team has led mass firings at the NHTSA, reducing the agency’s workforce and capacity to investigate companies including Tesla by about 10%.
Tesla didn’t respond to a request for comment.
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