Following a from the Food and Drug Administration (FDA), Owlet has stopped selling its popular Smart Sock family in the US. On October 5th, the agency contacted Owlet to tell the company it was selling the wearables “without marketing approval, clearance or authorization.”
In a spotted by , Owlet says it’s complying with the FDA’s request. It has stopped selling the socks while it seeks clearance from the FDA. The company says it will offer a “new sleep monitoring solution” in the near future.
“With over one million babies monitored, we are extremely proud of the innovation and technology Owlet has delivered,” the company said. “We will continue to stay focused on our mission and cooperate with the FDA so we can continue to provide sleep monitoring products and solutions to parents and babies.”
If you own the Smart Sock 3 or one of its predecessors, Owlet notes the FDA didn’t identify any safety with the wearables. It also hasn’t asked the company to issue a recall. Owlet says it will continue to support those products while it works on a new device.
In their latest book, Patient Zero: A Curious History of the World's Worst Diseases, Dr. Lydia Kang and Nate Pedersen delve into the fascinating histories of some of humanity's deadliest diseases and the society-preserving works of the scientists who the developed cures, vaccines and treatments to counter them. In the excerpt below, we take a look at the deployment of antibiotics and antitoxins in the fight against diphtheria, anthrax, and other deadly diseases.
Aside from putting barriers between us and plagues, the next primary approach to defeating them was to attack them directly, thanks to breakthroughs in science that created and discovered antibiotics and antitoxins. Some of these medicines aren’t simply employed against microorganisms like bacteria, but act as antifungals, antivirals, and antiparasitics as well. Today, there are more than a hundred types of medicines in this group. The World Health Organization (WHO) maintains a list of medicines deemed essential for a country’s healthcare system to best care for its citizenry, and a large chunk of those essential meds battle infectious diseases.
Some might assume that penicillin was the first definitive weapon discovered in our fight against pathogens, but there were several that preceded it and broke significant ground when they were discovered.
The Prussian-born Emil von Behring was a doctor and an assistant to the famed Robert Koch at the Institute for Hygiene in Berlin. In 1888, he developed a way to treat those suffering from diphtheria and tetanus. Not a disease familiar to many these days, diphtheria is prevented by a vaccine that is usually coupled with your routine tetanus shot. In the 1800s, diphtheria was a terrible killer that inflamed a victim’s heart, inflicted paralysis, and caused a suffocating membrane to cover the throat. In Spain, the disease was so rampant in 1613 it was nicknamed El Año de los Garrotillos, or “The Year of Strangulations.”
Much of the disease caused by diphtheria is driven by the toxin created by Corynebacterium diphtheriae. Von Behring infected rats, rabbits, and guinea pigs with weakened (attenuated) forms of it, then gathered their serum—the liquid fraction of their blood, minus the red and white blood cells. That light, honey-colored liquid, which contained antibodies to the diphtheria toxin, was then injected into another set of animals that were sickened with fully virulent diphtheria bacteria.
The newly infected animals given the serum didn’t die because they gained a passive form of protection against the toxin with the donated serum. In 1891, a child’s life was saved using this new method for the first time. The serum was produced in large quantities using animals like sheep and horses. At a time when 50,000 children died annually from diphtheria, it was a miraculous treatment.
Tetanus serum was created soon after, becoming a workable treatment by 1915. Today, antitoxins are used to treat botulism, diphtheria, and anthrax. The same principles of antitoxin treatment are utilized for antivenom therapy to remedy poisonous animal bites, including those from black widow spiders, scorpions, box jellyfish, and cobras. A treatment called passive antibody therapy, in which the serum of patients recovered from an infection is given to other sick patients (also called convalescent plasma therapy), may have been helpful during the COVID-19 pandemic, though data is still forthcoming. Antibodies against infections can not only treat diseases like toxic shock syndrome, but prevent infections during exposures, such as those for hepatitis A and B and botulism. But the antibodies themselves have been employed to treat more than just bites, stings, and infections. Intravenous immunoglobulins from pooled donors treat a variety of disorders, such as ITP (immune thrombocytopenia) and severe immune deficiency diseases.
Another antibody therapy—monoclonal antibodies—has been a game-changer in treatments over the last decade or so, the first one approved by the FDA in 1986. These specially designed antibodies are used to treat several types of cancers (melanoma, breast, and stomach, among many others) and autoimmune diseases (including Crohn’s disease, rheumatoid arthritis, and psoriasis). The antibodies themselves are Y-shaped proteins that bind to a specific protein. In doing so, they can elicit a whole range of effects: switching on or off immune system cascades, destroying cells, blocking or engaging cell activities. The antibodies only bind to a single antigen, hence “mono,” and are produced by clones of cells that churn out the antibodies in large amounts. Sometimes they can also be bound to radioactive particles, delivering radioactivity directly to a cancer cell. Others can be bound to a chemotherapy agent. Often, they work alone.
In the realm of cancer therapy, most of us have some understanding of chemotherapy. But the origin of the term chemotherapy itself actually came from the fight to treat infections, not cancer. At the turn of the twentieth century, antibiotics had yet to establish themselves as a cure for infections. That changed with a physician and scientist named Paul Ehrlich. He was born in 1854 in East Prussia (now Poland) where his father ran a lottery office. During his career, he took advantage of the burgeoning German dye industry to experiment on how cells looked stained with different chemicals. His love of color led to some notable idiosyncrasies, like carrying colored pencil stubs in his pockets. But Ehrlich’s work led to what would become the famous Ziehl-Neelsen acid-fast stain for tuberculosis. (Unfortunately, he also stained his very own TB bacteria from his sputum, though luckily survived the illness.) Later he collaborated with the aforementioned Emil von Behring, a Nobel Prize–winning physiologist, on serum therapy for tetanus and diphtheria.
But perhaps Ehrlich’s most notable discovery happened by accident as he sought a chemical cure to treat a specific disease—a “chemotherapy.” Specifically, he hoped to cure sleeping sickness, a disease caused by a microscopic parasite called Trypanosoma brucei. He had been working with a chemical called atoxyl (meaning “nontoxic”), ironically an arsenic compound. Ehrlich coined the term “magic bullet” related to his hope of finding that perfect chemical that would hopefully kill a very specific pathogen, the Trypanosoma parasite, and not the patient. He ended up testing nine hundred variations of the arsenic compounds on mice. None were particularly effective, but he revisited #606 because it seemed to have an effect on a newly discovered bacterium believed to cause syphilis. In 1910, the medicine called Salvarsan (sometimes simply called “606”) was proven to be effective—it killed the syphilis spirochete and left the guinea pigs, rabbits, and mice alive.
In the next few decades, new research would be applied to battle not just the pandemics of old, but daily infections that could upend people’s lives. A scratch or bite could kill if those Staphylococcus or Streptococcus infections spiraled out of control. A German scientist named Gerhard Domagk began working with a group of chemicals called azo dyes that had a characteristic double nitrogen bond. Azo dyes can color textiles, leather, and foods various shades of brilliant orange, red, and yellow. When an azo compound had a sulfonamide group attached (a nitrogen and sulfur link with two oxygen atoms double-bonded to the sulfur, should you need to impress friends at a party), they knew they’d found something special. The sulfonamide group inhibits a bacteria’s ability to make folate, a necessary B vitamin. Humans, on the other hand, can obtain folate through their diet. And so another magic bullet was born. The new compound seemed to work in mice infected with Streptococcus, otherwise known as strep.
Domagk used the new medicine, called KL 730 and later patented as Prontosil, on his own daughter Hildegard. Suffering from a severe strep infection, she received a shot of Prontosil and recovered, though the drug left a telltale dyed, reddish discoloration at the injection site.
“Sulfa” drugs would go on to be used in a variety of medicines, including antibiotics (trimethoprim and sulfamethoxazole, aka Bactrim), diabetes medicines (glyburide, a sulfonylurea), diuretics (furosemide, or Lasix), pain meds (celecoxib, or Celebrex), and are also used today to treat pneumonia, skin and soft tissue infections, and urinary tract infections, among others.
Domagk’s work won him the Nobel Prize in 1935. However, the Nazis, who disapproved of how the Nobel committee tried to help German pacifist Carl von Ossietzky, had their Gestapo arrest Domagk for accepting the prize and forced him to give it back. He was able to receive it later in 1947.
After offering free mental health exercises at the beginning of the pandemic, Headspace has announced that it's opening up its service for free to a particularly vulnerable group for mental stressors: teens. The company's new Headspace for Teens initiative is fairly straightforward: Kids between 13 and 18 will be able to access a selection of exercises — including things to help you reduce stress, focus on being mindful and sleep better — at no charge. The only requirement is that they sign up to be members of the youth-focused non-profits Bring Change to Mind or Peer Health Exchange. Headspace says it also plans to extend the free offering throughout the world as it partners with more non-profits.
“Through our research, we see that teens today are under a great deal of stress and experience high levels of anxiety due to the demands of school, their jobs, extracurriculars, social life, and a general uncertainty about their futures,” Alice Nathoo, Head of Social Impact at Headspace, said in a statement. “Even though many teens have an awareness of and vocabulary for mental health issues, this doesn't always translate to action."
Given just how anxiety-inducing the world can be these days, it makes sense for Headspace to give people a taste of the benefits from meditation, de-stressing and solid sleep habits. It's no replacement for a therapist — as we've explored in our guide to finding at-home mental health support during the pandemic — but Headspace's offerings still have the potential to help many people.
Last year, Alphabet’s DeepMind announced its showed it could predict how certain proteins would fold in a way that was competitive with experimental data. The news was met with enthusiasm by the scientific community, but it wasn’t clear at the time what the breakthrough would mean in practical terms. Now we have a better idea with Alphabet announcing the creation of a new subsidiary called .
The company states its goal is to “reimagine” the process of developing new drugs with an AI-first approach. “We believe that the foundational use of cutting edge computational and AI methods can help scientists take their work to the next level, and massively accelerate the drug discovery process,” Demis Hassabis, the founder and CEO of Isomorphic Labs said. Hassabis, who’s also the CEO of DeepMind, will serve as the chief executive of the startup while it builds out and hires additional employees.
Isomorphic Labs isn’t the first or only company to say it plans to streamline drug development with the help of AI. Since 2012, a startup out of the University of Toronto called has had a . They’re both trying to address the problem of skyrocketing drug development costs. A recent study found that it costs on average $1.3 billion to create a new pharmaceutical. A lot of that has to do with the process itself. As things stand today, researchers physically synthesize each and every promising compound and then test to see if it’s safe for human use. And as they have tried to develop treatments for more complicated diseases, fewer drugs are passing human trials.
Amazon has announced two new programs for centered around healthcare and retirement homes. Through , hospitals and senior living communities can run their own custom version of the voice assistant.
Retirement homes might tap into Alexa to help residents keep in contact with family and friends, stay in touch with staff, take part in activities and remain engaged with other members of the community. Staff members can use Alexa to broadcast announcements and, of course, the voice assistant can still be used for things like controlling connected devices and smart TVs.
Amazon's aim with the healthcare program is to, among other things, let staff members check in with patients without having to enter their rooms. In turn, patients can ask nurses questions, and they'll be able to respond to brief queries without having to leave their station. In addition, they can ask Alexa to play music or a podcast. As with the senior living program, care providers could use Alexa for announcements. This program builds on a at Cedars-Sinai Medical Center in Los Angeles.
A version of Alexa for healthcare providers is something that Amazon has had in the works for some time. A the company was developing hardware and software for healthcare projects, and those rumors . In 2019, Amazon rolled out the , which let providers help people manage prescriptions and provide blood glucose readings and tips to people with diabetes. It also has over the last couple of years.
Amazon isn't the only major tech company with an interest in the healthcare field. Microsoft into an AI for Health program and it earlier this year to buy speech tech company Nuance for $19.7 billion to boost its AI, cloud and healthcare ambitions.
Google, meanwhile, has worked closely with some healthcare providers. It to open an office in Rochester, Minnesota this year. The Mayo Clinic is headquartered there and the two sides plan to collaborate further.
Since 2011, has made a name for itself as a weight loss app. This week, with the introduction of a new feature called Noom Mood, it’s expanding into mental wellness. If you’ve already tried the aforementioned weight loss program, you’ll have a good idea of what to expect from Noom Mood.
As you embark on the four-month program, each day the app will provide you with articles and activities centered on teaching you skills you can use to manage and regulate the stress and emotions in your life. Along the way, you’ll be asked to log your mood, and if you ever need additional help, the program includes access to a personal coach.
It’s not surprising to see Noom expand beyond weight loss. It always had a , and it must be said there’s a lot of money to be made in the health and wellness space. Over the course of the pandemic, a company like Headspace went from a relatively obscure startup to one that now has a valuation and partnerships with companies like and .
Apple's health ambitions for AirPods might extend beyond using them to boost conversations. Wall Street Journalsources claim Apple is exploring multiple ways it can use AirPods as health devices. It might use the buds as hearing aids, but it could also use the motion sensors to correct your posture. A prototype would even include a thermometer to check your core body temperature, according to leaked documents.
The features wouldn't show up in 2022 and might not be available at all, the sources said. Apple declined to comment.
Apple would face numerous hurdles to marketing AirPods as health gadgets. The company would likely require regulatory clearance for at least some features. A US Food and Drug Administration ruleset due in 2022 might make that possible, but it could still take months to approve the earbuds. Even Bose had to wait a long time before it could sell its FDA-cleared SoundControl hearing aids.
There are technical challenges, too. Right now, AirPods Pro won't last longer than 4.5 hours for listening (with noise cancelling on), and 3.5 hours for calls — that just wouldn't be practical for health wearables that might need to sit in your ears all day. They'd also need to be comfortable for long periods and adapt to varying types of hearing loss.
It's easy to see why Apple might expand the AirPods' usefulness, though. As with the Apple Watch, health could be a selling point that grow the audience beyond the enthusiast core. It might also court a relatively underserved market of people who may have mild or moderate hearing loss, but either can't afford most hearing aids or don't like the limited functionality and drab designs that often define the category.
Withings' ScanWatch has received FDA clearance, paving the way for it to be sold in the US starting in November, the company announced. The watches, available in regular and diver-style Horizon versions, have simultaneously been cleared to take electrocardiogram (ECG) and SpO2 (oxygen saturation) readings, in health and medical settings.
The original ScanWatch has been available in Europe since it came out a year ago, but FDA clearance has taken much longer. Both models use ECG readings to check for atrial fibrillation (heartbeat irregularities), and you can even download the results and mail them to your doctor as a PDF. If it notices any irregular heartbeats, it will advise you to take an ECG test.
We found the ScanWatch to be the best hybrid smartwatch out there, offering a traditional analog watch look and a small PMOLED display to display activities, heartrate, ECG, SpO2 and more. As with Withings' scales and other health devices, it works with the company's Health Mate app.
Sales will commence in early November 2021, with prices starting at $279 for the original ScanWatch 38mm model. The Rose Gold and Horizon versions will will be available in early 2022 priced from $299 and $499 respectively.
Since 2009, companies handling health records have been required to notify consumers if their data is breeched. Now, the rule has been extended to health apps that track fitness, vital statistics, sleep and more. The FTC ruled 3-2 that companies producing such apps must inform users impacted by data breaches, lest they face a financial penalty of over $43,000 per day, The Hill has reported.
"As many Americans turn to apps and other technologies to track diseases, diagnoses, treatment, medications, fitness, fertility, sleep, mental health, diet, and other vital areas, this Rule is more important than ever," the FTC wrote in the ruling. "Firms offering these services should take appropriate care to secure and protect consumer data."
A more fundamental problem is the commodification of sensitive health information, where companies can use this data to feed behavioral ads or power user analytics.
Recent high-profile breaches include UnderArmour's MyFitnessPal breach that affected 150 million users in 2018. A more recent data leak came about due to an exposed server that contained 61 million records related to fitness trackers and wearables that exposed Apple and Fitbit users' data online.
The rule passed along party lines, with the majority Democratic commissioners voting 3-2 in favor. However, the Republican commissioners dissented because the FTC was already working on revamping health breach notification rules. "The right way to go about it is to conclude the ongoing rulemaking process, especially when the statutory and regulatory interpretation on which the majority rely is far from clear," said commissioner Noah Phillips.
FTC Chair Lina Khan said the ruling is just the start of what's needed. "A more fundamental problem is the commodification of sensitive health information, where companies can use this data to feed behavioral ads or power user analytics," Khan said. "The Commission should be scrutinizing what data is being collected in the first place and whether particular types of business models create incentives that necessarily place users at risk."
During Crimean War, hospitals of the day weren't so much centers of healing or recovery as they were the places where injured combatants went to die slightly more slowly. Turkey's Scutari hospital was one such notorious example. Converted by the British Empire from army barracks, Scutari lacked every imaginable amenity, from basic sanitation to sufficient ventilation, this "hospital" served as a potent incubator for myriad infectious diseases — that is until Florence Nightingale and her team of volunteer nurses arrived in 1854.
Maladies of Empire by Jim Downs explores how many aspects of modern medicine are borne on the backs of humanity's most abhorrent impulses, though in the excerpt below, Downs illustrates how one woman's unyielding tenacity and fastidious record keeping helped launch the field of preventative medicine.
While in Scutari, Nightingale developed a system of record keeping that tracked a variety of factors at the Barrack Hospital and the nearby General Hospital. She took notes on everything from cleanliness to the quantity of supplies to diet to the placement of latrines and graveyards.
She also carefully examined the physical space. She took careful note of the size of the wards, the condition of the roof, and the quality, size, and placement of the windows. In her book on the health of the British army, like Thomas Trotter and others who wrote about the importance of fresh air, she pointed to the problem of improper ventilation, and she devoted an entire section to “bad ventilation.” She quoted the report of the sanitary commission, which remarked on the “defective state of the ventilation” in the Barrack Hospital. There were only “a few small openings here and there,” so that there was no way for the “hot and foul” air to escape. As an adherent of the miasma theory, she believed that diseases were spread through the air and advocated for ventilation to release the “foul air” from hospitals.
In addition to inadequate ventilation, Nightingale pointed to poor drainage and badly designed sewers and plumbing. In her testimony to the royal commission, Nightingale reported on the filthy conditions she found in the Barrack Hospital when she arrived. “The state of the privies... for several months, more than an inch deep in filth, is too horrible to describe.” She observed six dead dogs under one of the windows, and a dead horse lay in the aqueduct for weeks. The drinking water was dirty; once she saw used hospital uniforms in the water tank. Rats and insects abounded, and “the walls and ceilings were saturated with organic matter.”
In the conclusion to her report on the health of the British Army, she explained, “We have much more information on the sanitary history of the Crimean campaign than we have upon any other, but because it is a complete exam (history does not afford its equal) of an army, after failing to the lowest ebb of disease and disaster from neglects committed, rising again to the highest state of health and efficiency from remedies applied.
"It is the whole experiment on a colossal scale.” She pointed out that during the first seven months of the Crimean campaign, mortality exceeded that of the plague of 1665 as well as that of recent cholera epidemics. But during the last six months of the war, after sanitary reforms had been made, “we had... a mortality among our sick little more than that among our healthy Guards at home.”
Using mortality data that she had collected during the war, along with domestic mortality statistics, Nightingale showed that between 1839 and 1853, mortality among soldiers was much higher than among civilian men: “of 10,000 soldiers [at the age of 20], 7,077 live to the age of 39, out of whom 135 die in the next year of age; whereas out of 10,000 civilians at the age of 20, 8,253 attain the age of 39, and of those 106 die in the year of age following.” Nearly all mortality among soldiers was the result of disease; “actual losses in battle form a very small part of the calamities of a long war.” Nightingale classified the causes of death as “zymotic diseases” (which in the nineteenth century referred to infectious diseases such as fevers, measles, and cholera), “chest and tubercular diseases,” and “all other diseases (including violent deaths).” Nightingale was critical of the army’s classification system for diseases. At the bottom of a chart, she notes, “Bronchitis and influenza have no place in the Army nomenclature. The chronic catarrh of the Army Returns is believed to be really phthisis, in the great majority of cases; acute catarrh comprehends both epidemic catarrh, or influenza and bronchitis.”
Nightingale presented statistics using charts, tables, and diagrams, which were just beginning to appear in research reports, to make it easier for readers to visualize the comparison she was making. She developed a new kind of graphic, called a “rose chart,” also known as a coxcomb chart or polar area diagram, to present mortality data from the Crimean War. Each chart, which is laid out like a pie, shows data from one year, with the slices representing months. Each slice is divided into colored segments whose area is proportional to the number of deaths.
One segment is for deaths from wounds, a second for “preventable or mitigable zymotic diseases,” and a third for all other causes. A quick glance at the charts of deaths from April 1854 to March 1855 and April 1855 to March 1856 is enough to show that many more deaths were caused by disease than by combat, and that overall mortality decreased in the second year.
To further make visible the dangers of unsanitary hospitals, Nightingale gathered mortality data for matrons, nuns, and nurses working in fifteen London hospitals who died of the “zymotic diseases” of fever and cholera. She presented tables, which she notes William Farr compiled for her, showing that the mortality rate of the nursing staff was much higher than that of the female population in London; in addition, women working in hospitals were more likely to die of zymotic diseases than were other women. She used these figures to argue for the “very great importance” of hygiene in hospitals. “The loss of a well-trained nurse by preventible [sic] disease,” she wrote, “is a greater loss than is that of a good soldier from the same cause. Money cannot replace either, but a good nurse is more difficult to find than a good soldier.”
In her book Notes on Hospitals, she retold the story of the British prisoners of war who died in a crowded jail cell in India in 1756: “Shut up 150 people in a Black hole of Calcutta, and in twenty-four hours an infection is produced so intense that it will, in that time, have destroyed nearly the whole of the inmates.” Nightingale’s reference to the case is evidence for its status as the prototypical illustration of the need for ventilation. And the fact that it took place in India shows how British medical authorities used information from around the empire.
As a result of her work with large numbers of patients in the Crimean War, Nightingale framed her analysis like an epidemiologist, in terms of populations. She focused on how disease spread within a group. She devoted her energies not to changing bedpans or dressing wounds but to studying the structure of hospitals, analyzing statistics, and figuring out how to increase ventilation.
The war provided her the opportunity to compare mortality rates in varied settings: crowded hospitals, shabby tents, and wooden huts. It also underscored to her the importance of preventive measures, which constitutes one of the major tenets of modern epidemiology. By publishing her observations, her insights, and guidelines for hospitals to follow, she hoped to provide a set of rules and guidelines for physicians to follow to prevent the spread of disease. While efforts to ensure proper hygiene as a way to guard against illness can be traced to Mesopotamian civilization and Sanskrit writings from 2000 BCE, Nightingale’s warnings, in particular, and sanitary reform, more generally, sparked a critical turning point in the middle of the nineteenth century that gave rise to preventive medicine. This transformed military medicine from an enterprise that largely focused on treatment and surgery to one that began to engage epidemiological questions and issues.