Posts with «health care industry» label

Spotify reportedly has a very limited set of COVID content guidelines

When Spotify started removing Neil Young's playlist from its service, it defended its practices against misinformation and said that it had already pulled over 20,000 COVID-related podcast episodes. Young threatened to remove his catalog from the service over allegations that Joe Rogan is spreading COVID-19 vaccine misinformation through his podcast. Despite what Spotify said, The Joe Rogan Experience is still available on the platform, and Spotify's COVID content policy (as seen by The Verge) might be able to explain why that's the case. 

Apparently, even Spotify's employees are upset with the company's partnership with Rogan due to his views on COVID-19. Company head of global communications Dustee Jenkins reportedly addressed those concerns on Spotify's Slack and told employees that a team had already reviewed multiple controversial Joe Rogan Experience episodes and found that they "didn't meet the threshold for removal." She called members of the team who did the internal review "some of the best experts in the space" and also said that Spotify is working with third parties to help it evolve its policies. "What Spotify hasn't done is move fast enough to share these policies externally, and are working to address that as soon as possible," she added. 

While Spotify has yet to share those policies, The Verge posted a copy of the healthcare guidelines section, which prohibits:

"Content that promotes dangerous false or deceptive content about healthcare that may cause offline harm and/or pose a direct threat to public health such as:

Denying the existence of AIDS or COVID-19

Encouraging the deliberate contracting of a serious or life threatening disease or illness

Suggesting that consuming bleach can cure various illnesses and diseases

Suggesting that wearing a mask will cause the wearer imminent, life-threatening physical harm

Promoting or suggesting that the vaccines are designed to cause death"

There's a lot podcasters can get away with with such a narrow and limited set of rules. In comparison, YouTube makes it clear that any content with claims that contradict local health authorities or WHO is prohibited on its website. It's not just suggestions that wearing a mask will cause harm that's prohibited on the Google-owned service, but also claims that masking does not help prevent the contraction or transmission of COVID-19. A podcast host on Spotify can say the latter without repercussions. Spotify also doesn't have a rule prohibiting claims that ivermectin is a safe and effective treatment for the virus. 

Back in December, a group of scientists and doctors sent an open letter to Spotify, asking it to implement a misinformation policy after Rogan guested Dr. Robert Malone on his show. In the controversial episode, Malone claimed people only believe that COVID-19 vaccines are effective due to "mass formation psychosis." The group also listed several "misleading and false claims" Rogan made on his podcast throughout the pandemic, including the time he said mRNA vaccines are "gene therapy" and another when he promoted the use of ivermectin to treat COVID-19.

Moderna begins early-stage trials of mRNA-based HIV vaccine

Moderna has begun early-stage clinical trials of an HIV mRNA vaccine, the company announced this week. On Thursday, it administered the first doses of a shot it co-developed with the International AIDS Vaccine Initiative to volunteers at the George Washington University School of Medicine and Health Sciences.

Like the company’s COVID-19 vaccine, the new treatment uses messenger RNA to “trick” the human body into producing proteins that will trigger an immune response. Moderna hopes the shot will induce a specific class of white blood cells known as B-cells, which can then turn into broadly neutralizing antibodies. Those proteins are “widely considered to be the goal of HIV vaccination, and this is the first step in that process,” according to the company.

As part of the trial, Moderna plans to test both a primary vaccine and a booster shot. The Phase 1 trial will involve 56 healthy, HIV-negative adult participants. The company will give 48 of those individuals the mRNA vaccine. Thirty-two of that group will also receive the booster shot. To the final eight involved in the first trial, the company will only administer the booster shot. Moderna says it will then monitor the entire group for six months to gauge the safety of the vaccine. It also plans to examine the immune response the vaccine triggers at the molecular level to determine if it’s effective.

Messenger RNA technology could lead to treatments for a host of deadly diseases, including malaria, but a breakthrough against HIV would be particularly noteworthy. According to statistics from the US government, approximately 1.2 million Americans have the virus, which can lead to the deadly AIDS disease. While outcomes for HIV patients have improved significantly since the ‘90s thanks to the development of new treatments and medication, no HIV vaccine has successfully passed early clinical trials.

German Bionic's connected exoskeleton helps workers lift smarter

We’re still quite a ways away from wielding proper Power Loaders but advances in exosuit technology are rapidly changing how people perform physical tasks in their daily lives — some designed to help rehabilitate spinal injury patients, others created to improve a Marine’s warfighting capabilities, and many built simply to make physically repetitive vocations less stressful for the people performing them. But German Bionic claims only one of them is intelligent enough to learn from its users’ mistaken movements: its 5th-generation Cray X.

The Cray X fits on workers like a 7kg backpack with hip-mounted actuators that move carbon fiber linkages strapped to the upper legs, allowing a person to easily lift and walk with up to 30kg (66 lbs) with both their legs and backs fully supported. Though it doesn’t actively assist the person’s shoulders and arms with the task, the Cray X does offer a Smart Safety Companion system to help mitigate common lifting injuries.

“It's a real time software application that runs in the background and can warn the worker when the ergonomic risk is getting too high,” Norma Steller, German Bionic’s Head of IoT, told Engadget. “For example, recommending a break because we know that… the repetition and the overall stress can lead to fatigue, and fatigue can lead to injuries. This is something we want to prevent.”

The SSC not only collects granular telemetry information — what load is being lifted, ergonomic risks such as twisting while lifting, and potential environmental factors — it uses a machine learning algorithm to analyze that data to adapt the exoskeleton to the worker wearing it via OTA software updates. Not only is this data displayed to the workers themselves on an attached monitor, the Cray X also transmits that data up the supervisory chain allowing managers to monitor the movements of their employees to ensure that they are not overexerting themselves.

“Since we are collecting every single step and every single lift, the data that we provide is much more accurate,” Steller noted. The data the Cray collects is gathered from real-world use, not lab tests or supervised trials where workers are on their best ergonomic behavior. “Especially in logistics, every single step, every single lift, every single trend is usually planned. But sometimes in the real world, not every plan comes to fulfillment and then we suddenly see workplace performance drop very, very quickly. And with the data we provide, you can actually do an investigation and figure out why [that drop off is occurring].”

Steller sees the Cray X as a "preventative device" designed to ensure workers don't overextend or overexert themselves. “We are a preventative device, so we are preventing injury,” Steller added. “We're not considered a medical [device manufacturer]. We consider ourselves an exoskeleton for industrial use.” As such, the Cray X is IP54 rated for dust and moisture so it can work in all but the dingiest of warehouse environments.

And though the Cray X is designed to be put on and taken off in under a minute, it can be worn for up to a full work shift without being removed thanks to the 5th generation’s new hot-swappable 40V battery system.

“We implemented the hot swapping function so that you can just drop it on the spot without having to turn off the device,” Mauris Kiss, Head of Mechanical R&D at German Bionic, told Engadget. “You can pull out the [spent battery] for a new one, place the old one on the charger — we use the Makita fast charging stations which charge the battery in like 30 to 40 minutes — and then you can just move on. You could potentially work like eight hours without having to take off the exoskeleton.”

For as useful as the current generation of exoskeletal technologies are today, the German Bionic team sees them becoming even more capable, and widespread, in the years ahead. “My feeling is that we will see much more specialized exoskeletons in the future because the technology is more available.” Steller said. “I think they will enter our world, not only in the B2B industrial sectors. We will see them basically everywhere because we have the chance to augment our body and usually humans take the chance to do that. We will see them everywhere, without any real limitation but very specialized to the use case.”

“I really see everyone on the street wearing an exoskeleton in one form or another,” Eric Eitel, German Bionic’s Head of Communications, added. “But I think that the exoskeletons that we are looking for in the future are the active ones. I see them being a lot slimmer, smarter and connected.”

And even as the technology expands to consumer uses, Eitel believes exoskeletons will likely remain a common sight in industrial settings. “There are still a lot of workspaces that cannot be automated and I think that's going to stay like that for a long time. You still have to rely on people so we don't want to replace all the humans. I really see that technology is going alongside [automation].”

“We see robots more as companions, our product is actually a companion,” added Kiss. “I think this can be just another possibility, I mean, there's still situations where automation still makes a lot of sense. When you go into dangerous environments, you should actually automate that. But why should we automate everything?”

US surgeons implant genetically altered pig kidneys in a brain-dead patient

A group of surgeons from the University of Alabama at Birmingham has proven that it's possible to genetically alter a pig so that its kidneys can be used on human transplant patients. The doctors have transplanted kidneys from a genetically altered pig into the abdomen of a brain-dead man, and as The New York Times has reported, the procedure was described in a paper published in the American Journal of Transplantation

According to the doctors, the kidneys from the pig started producing urine as soon as 23 minutes after the procedure and continued to do so for three days. The patient's kidneys were fully removed, and his body didn't show signs of rejecting the transplanted organs. This is the latest in a series of developments wherein organs from genetically altered pigs were successfully transplanted into humans. In late 2021, NYU Langone Health doctors attached a pig kidney onto the blood vessels of a brain-dead patient's upper leg. And, just a few days ago, doctors at the University of Maryland School of Medicine transplanted a pig's heart into a live patient as part of an experimental procedure.

The UAB surgeons performed the procedure with consent from the family of the recipient, James Parsons, who wanted to be an organ donor. They're now naming this type of study after him. While the recipient was brain dead in this case, it's a big step towards a clinical trial involving live patients that they're hoping would start later this year. Dr. Jayme Locke, the team's lead surgeon, said this wasn't a one-off experiment, and that the hope is to "advance the field to help... patients." The doctor who serves as director to UAB's Incompatible Kidney Transplant Program added: "What a wonderful day it will be when I can walk into clinic and know I have a kidney for everyone waiting to see me."

Based on data from the Organ Procurement and Transplantation Network, there are currently 90,272 people on the waiting list for kidney transplant. In addition, around 3,000 new patients are added to the waiting list for the organ each month. Dr. Locke said "kidney failure is refractory, severe and impactful" and that "it needs a radical solution." She hopes to be able to offer life-saving pig kidney transplants to patients within the next five years.

Rapid COVID tests will soon be fully covered by insurance in the US

With the COVID-19 Omicron variant surging in the US and elsewhere, testing is key to allowing work, school and entertainment activities to continue. With rapid test kits in short supply, though, some retailers are making them unaffordable by gouging customers. Now, the Biden administration has announced that testing kits must be covered by private insurance, The Wall Street Journal has reported. 

People covered by private health insurance can be reimbursed for up to eight tests a month per individual. To make things simpler, the White House is encouraging insurers to partner with retailers and pharmacies so people can pick up tests without paying up front or submitting a claim. The tests are available without deductibles, coinsurance or co-payment, so a family of four on the same health plan could be reimbursed for 32 tests a month, for instance. For such programs, reimbursement would be limited to $12 per test. 

Today’s action further removes financial barriers and expands access to Covid-19 tests for millions of people.

The new policy doesn't apply to Medicare, which counts more than 60 million seniors at higher risk for COVID-19 complications. However, Medicaid for low income folks already covers at-home COVID-19 tests authorized by the FDA. The administration also plans to make tens of millions of free tests available to uninsured Americans at health clinics and other sites, according to The New York Times

Some insurers said that the administration is acting too late and that it didn't address the shortage of at-home tests. However, one national association of coverage providers said that the new plan "takes steps to mitigate the real risks of price gouging, fraud and abuse."

Having enough diagnostic tests will be key to slowing down the Omicron wave that is starting to overwhelm health systems in the US and elsewhere. It can help get infected people isolated or into treatment more quickly, reducing potential transmission and hospital workloads. 

That will become even more important given authorization for antiviral pills from Pfizer and Merck that can help high-risk patients with mild to moderate COVID symptoms — provided they're diagnosed in time. "This policy will help millions of families afford COVID tests that allow them to be in school, visit family members and live their lives," Georgetown University's Sabrina Corlette told the WSJ

Surgeons successfully transplant genetically modified pig heart into human patient

In a desperate effort to save the life of a 57-year-old man, doctors at the University of Maryland School of Medicine have accomplished a medical first. Per The Associated Press, this past Friday, surgeons successfully transplanted a pig heart into a patient as part of an experimental procedure.

In doing so, they showed a genetically modified animal organ could survive and function within the human body without immediate rejection. Three days after the procedure, David Bennett, the individual who underwent the surgery, is alive and “doing well,” according to the hospital.

The Food and Drug Administration authorized the procedure on compassionate grounds. Bennett was ineligible for a traditional heart transplant and had run out of other options. “It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice,” he said in a statement before doctors operated on him.

Scientists have tried to save humans with animal organs for decades. One of the most notable attempts occurred in 1984 when doctors grafted a baboon heart into Stephanie Fae Beauclair, an infant born with hypoplastic left heart syndrome. The congenital disorder left her body incapable of circulating blood properly. Baby Fae, as she was better known, survived for 21 days before her body eventually rejected the transplanted organ.

According to The New York Times, what makes this latest procedure different is doctors used a heart that had been genetically modified to remove four genes that encode a molecule that causes the body to reject the orphan organ. They also inserted six human genes to make the immune system more tolerable of the foreign tissue. Whether the experiment represents a breakthrough will depend on what happens next. Bennett’s body could still reject the pig heart. For the moment, however, he’s alive, and doctors are understandably excited about what this could mean for patients.

“If this works, there will be an endless supply of these organs for patients who are suffering,” Dr. Muhammad Mohiuddin, scientific director of the University of Maryland School of Medicine’s xenotransplantation program, told The Associated Press. That would be a dramatic change from the status quo. According to the Health Resources and Services Administration, more than 100,000 people are on the national transplant waiting list, and 17 individuals die every day waiting for an organ transplant.

Withings' Body Scan scale can measure the composition of different parts of your body

Over five years after the release of the Body Cardio (and one flirtation with Nokia), French company Withings has released its far most technologically advanced connected scale yet, the Body Scan. The big change over the last model is the addition of a handle with four stainless steel electrodes that allows it to measure ECG, segmented body composition (fat/water in your arms, legs and torso) and even esoteric things like nerve activity. All of these features will also make it one of the most expensive scales yet when it arrives to market. 

Withings says it's the number one US smart scale manufacturer and created the Body Scan "because users are demanding more and more medical and health data and information," Withings CEO Mathieu Letombe told Engadget in French. 

Withings

The new scale is certainly designed to deliver that. Though the design and high-strength tempered glass construction are similar to the previous Body Cardio, it's loaded with extra sensors that can tell you more than ever about your body. That includes four weight sensors, 14 ITO (Indium tin oxide) electrodes within the platform and four stainless steel electrodes on the new handle. The battery can now go for a year between charges compared to nine months before and it packs a larger, higher-resolution 3.2-inch LCD color display.

The handle allows safe, low-level electrical signals to pass through your entire body, not just your feet — much as you may have seen on some advanced gym scales. To start with, that enables a new 6-lead ECG that can detect heart arrhythmias via two sets of electrodes on each side of the handle and one within the base of the sale. That compares to a single lead on smartwatches, so the Body Scan can deliver more specific results "that can easily be ready by a cardiologist," said Letombe. 

An embedded algorithm can detect heart patterns associated with atrial fibrillation, showing the results on the display or Withings' Health Mate app. Those can be stored to show trends or "shared with medical professionals from the app," according to Withings. "Each time you weigh yourself, the scale can deliver that information, thanks to the new handle." 

In terms of your weight, Withings claims the Body Scan is accurate to within 0.1 pounds (50 grams) or double the previous model, but that's just the start of showing your body makeup. It uses multi-frequency bioelectrical impedance analysis (BIA) to measure whole-body fat and water percentage, visceral fat, muscle and bone mass and extracellular and intracellular water. It can even provide readings for individual body parts, including your torso, arms and legs. All of that allows you to spot things used by health experts and sports professionals like dangerous localized fat or muscle imbalance, Withings said. 

Working with a French company called Impeto Medical, Withings also developed a feature to assess nerve activity. It can track sweat gland activity in the feet (sudomotor function) using a small direct current via the electrodes located in the plate. Impaired function in that regard could show signs of degeneration of small nerve fibers, something that can be corrected with regular activity and a healthy diet. 

"It's a useful function, because there are a lot of chronic health issues like obesity associated with poor nerve function," Letombe told me. "Impeto creates devices used by neurologists and others doctors that can cost upwards of 10,000 euros, and the Body Scan is a consumer product that, again, does that every time you weigh yourself." At the same time, Withings will be able to collect nerve activity data from millions of users that could be useful for medical research and patient care.

Withings

Along with the scale, Withings is also introducing (yep) a subscription service, with the price yet to be announced. It will "allow users to connect with medical specialists for advice and consultation while providing clinical teams with data in real-time," Withings said. It'll also offer personalized health plans, videos and more covering topics like nutrition, sleep, exercise and stress management to help users with their health goals. 

With the Body Scan, Withings will be offering consumers one of the more advanced health, sports and medical home devices out there — at a price. It's expected to cost $300 when it arrives to the US and Europe in the second half of 2022 following FDA clearance, or $100 more than the Body Scan's launch price. That will include three free months of the subscription service, but it's still big chunk of change for a scale. 

A lot will depend on whether it delivers on all the promised features with reasonable accuracy and if it receives its FDA clearance in a timely manner. That's not necessarily a given, as it took Withings well over a year to get its ScanWatch cleared by the FDA after it was first released. The company also had issues with its Pulse Wave Velocity (PVW) heart health feature, and pulled it in some regions over regulatory concerns. 

Given all that, it's fairly bold on Withings' part to introduce a scale with even more advanced medical and health functionality. "We think that's how we can advance a user's health, not by asking an extra effort, but delivering more targeted information on a product they use every day," said Letombe.

Follow all of the latest news from CES 2022 right here!

Merck's COVID-19 antiviral pill is the second authorized by the FDA

Pfizer's COVID-19 antiviral pill will already have some competition in the US. As the Associated Pressreports, the Food and Drug Administration has given emergency use authorization for Merck's Molnupiravir pill. The treatment limits replication of SARS-CoV-2 by inserting "errors" in the virus' genetic code while an infection is relatively young, ideally preventing mild or moderate cases from becoming severe in high-risk patients.

The medicine might not get as much use as Pfizer's Paxlovid, however. Merck's offering will only be available to those 18 years or older versus 12 years for Pfizer's, as there are concerns it might affect bone and cartilage development in younger patients. There are also warnings against using it during pregnancy or while attempting to conceive — the FDA said people should use birth control both during and after treatment, with women waiting days and men waiting three months.

Molnupiravir also doesn't appear to be as effective as Paxlovid. While Pfizer's solution reduced hospitalization and death by as much as 90 percent, Merck's only managed 30 percent. This pill may become the secondary option, particularly in situations where Paxlovid isn't available. Both companies' products are expected to remain effective against the virus' Omicron variant as they don't target mutating spike proteins.

Still, this might become another useful tool for minimizing COVID-19 hospitalizations and deaths. Pfizer's pill will be the most readily available when the US is ordering enough to treat 10 million patients, but there will be enough of Merck's drug to address 3.1 million. Even if the effectiveness is limited, that could spare hundreds of thousands of people from the worst the disease has to offer.

FDA authorizes Pfizer's Covid antiviral pill for people 12 and older

The FDA has issued an emergency authorization Pfizer's antiviral pill Paxlovid, making it the first oral method for treating mild to moderate cases of COVID-19. The treatment is meant for high-risk people 12 and older who could progress to a more serious COVID infection. The best part? The FDA says it could be available to use within a few days, making it another tool as we face the Omicron variant wave.

Paxlovid is available by prescription only, and it's meant to be taken within five days of first noticing COVID symptoms. According to Pfizer's tests, it can prevent hospitalization or death by 88 percent in high-risk patients. The treatment, which can be prescribed to both vaccinated and unvaccinated people, consists of 30 pills taken over five days. It includes the protein inhibitor nirmatrelvir and rotinavir, which keeps that inhibitor from breaking down in your body. Side effects include an impaired sense of taste, high blood pressure, diarrhea and muscle aches. 

“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19," Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

So far, the US has ordered enough pills to treat 10 million people, the New York Times reports. The company plans to deliver enough pills to cover 65,000 Americans within a week. And after that, production is expect to ramp up, with 150,000 courses delivered in January and 150,000 in February. It also won't be the only antiviral pill around: Merck's competing treatment is expected to be approved soon, and it'll likely be more readily available than Pfizer's. Merck's option is far less effective, though—tests show it can only prevent hospitalization or death by 30 percent. (Still, that's better than having no treatment.) 

Owlet stops selling infant monitoring sock after FDA order

Following a warning letter 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 response spotted by Deseret News, 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.