Posts with «health care industry» label

FDA asks COVID-19 vaccine makers to update boosters to target new omicron variants

The Food and Drug Administration has asked COVID-19 vaccine makers to update booster shots to tackle newer omicron variants that are on the rise. It says the manufacturers should add a spike protein component to shots to target the omicron BA.4 and BA.5 variants in addition to the original strain.

An "overwhelming majority" of the FDA's advisory committee voted this week in favor of updating shots with an omicron component, in the hopes of starting to use those modified boosters in the fall. The advisory is only for booster shots and not primary inoculations.

Vaccine makers are essentially playing whack-a-mole with the various strains of COVID-19. Pfizer and Moderna have created versions of their vaccines that target BA.1, the omicron variant that caused a significant upswing in COVID-19 cases during the winter.

However, that strain isn't circulating in the US anymore, according to the Centers for Disease Control and Prevention. Earlier this week, the CDC said BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the US. That figure is expected to rise in the coming weeks.

As CNBC notes, Pfizer and Moderna released clinical trial data this week showing that the current omicron shots performed better against BA.1 than the original versions of their vaccines in terms of offering a stronger immune response. While the immune response against BA.4 and BA.5 was still said to be robust, the omicron inoculations were less effective against those strains. It's unclear how long it will take vaccine makers to develop shots that take aim at BA.4 and BA.5.

"Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an omicron BA.4/5 component," the FDA said. "Manufacturers will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves."

FDA bans sales of Juul vape products in the US

The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the US. It ordered the company to remove its wares from the market or face enforcement actions. 

Reports earlier this week suggested that an FDA ban on Juul products was imminent. After a two-year review, the FDA rejected Juul's application to keep selling tobacco- and menthol-flavored pods as well as its vape pen.

The decision doesn't apply to Juul pens and pods that are already in the possession of the company's customers. However, it'll be difficult, if not impossible, to find those products in the near future.

In 2020, the FDA began a comprehensive review of all e-cigarette products sold in the US. It weighed up the potential benefits of vaping vs. cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has permitted other manufacturers to continue selling vape products, including NJOY and Vuse parent Reynolds American. To date, the agency has authorized 23 "electronic nicotine delivery systems" (to give vape pens their formal name).

In Juul's case, though, the FDA said the company's application "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications."

The agency went on to say that it doesn't have clinical information that suggests there is "an immediate hazard" linked to Juul's pen or pods. "However, the [marketing denial orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products," the FDA said. It noted that it's not possible to grasp the possible harms of using other pods in a Juul vape pen or the company's pods in third-party devices.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

Juul can appeal the decision or challenge it in court. Engadget has contacted the company for comment. 

The company became the leader in the US e-cigarette market in 2018. However, sales have dropped following a string of controversies. Juul slipped to second place behind Vuse in terms of US market share. The vast majority of the company's revenue comes from the US, The Wall Street Journal noted this week. 

Juul had been accused by federal agencies, state attorneys general and other officials of marketing its products to teens. The company agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington state, and faced suits in several other states. 

The company halted sales of mint- and fruit-flavored vape pods in 2019 before the FDA banned most flavored variants in early 2020. According to the Centers for Disease Control and Prevention, nearly 85 percent of young people who had used e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall. In 2019, Juul revealed a new, connected version of its vape pen that can verify a user's identity in an attempt to prevent underage use. 

FDA clears Rune Labs to use the Apple Watch to monitor Parkinson's

Turns out the Apple Watch’s motion sensors can be a useful tool for Parkinson’s patients and their physicians. The FDA has granted approval to Rune Labs to use their software paired with the Apple Watch to track symptoms of Parkinson’s disease, Reutersreported today. The San Francisco-based digital health startup has created software for watchOS that can detect common Parkinson’s symptoms such as tremors, involuntary or slow movement, rigidity and poor balance. Smartphone and other remote forms of monitoring Parkinson’s have been around for a while, but this is the first software designed for the Apple Watch that the FDA has cleared for motion disorders.

Since the Apple Watch Series 4 was first released in 2018, the wearable has been able to detect hard falls and offer advanced activity metrics. The company that same year added a Movement Disorder API to its open-source ResearchKit, opening the door for developers to create watchOS apps to track Parkinson’s and other diseases. As Rune Lab notes, the company is the first to make use of the API for commercial purposes.

The watchOS app by Rune Labs will give physicians access to patient movement data over time, which can further supplement the information they get from an in-person physical exam. Rune Labs also notes the Apple Watch’s tools aren’t capable of giving patients a complete picture of their disorder. “Of course, there are limitations to Apple's Movement Disorder kit: tremor and dyskinesia are only two symptoms in Parkinson’s Disease, and the classifiers themselves are not yet perfect,” wrote Rune Labs founder Brian Pepin last year in a blog post.

Apple has focused a lot of time and money on expanding and updating the Watch's health and fitness tracking capabilities, with many more to come in future updates. Earlier this month the FDA also cleared watchOS's AFib History feature — which monitors irregular and extremely rapid heartbeat — and will be released in the upcoming watchOS 9 update. 

Shields Health Care hack may have exposed data for 2 million people

Shields Health Care Group, a Massachusetts-based company involved with imaging and health management services, has announced a major hack that could have exposed sensitive information for up to two million people. The company learned of the attack on March 28th, and after an investigation it found that a malicious actor had access to some of its systems between March 7th and 20th. 

Crucially, the hack included sensitive information like social security numbers, medical record information, patient IDs and insurance details. The company claims there isn't any evidence of identity theft from the incident, but there's still a chance customers could be compromised down the line. 

"Upon discovery, we took steps to secure our systems, including rebuilding certain systems, and conducted a thorough  investigation to confirm the nature and scope of the activity and to determine who may be affected," the company said in a statement. "Additionally, while we have safeguards in place to protect data in our care, we continue to review and further enhance these protections as part of our ongoing commitment to data security."

Shields says it has contacted the FBI, as well as local and state regulators, about the incident. According to the AP, the FBI isn't commenting on the attack yet. Moving forward, Shields says it will contact customers once it learns who's affected.

watchOS 9 will include improved sleep tracking and medication reminders

Apple is at last promising better sleep tracking for Apple Watch as part of watchOS 9. The Sleep app will add a sleep stage function. It will be able to detect the REM, core and deep sleep stages and track those over time. Those who participate in the Apple health research program will be able to submit their sleep stage data to researchers for a new study.

One of the more notable health features for watchOS 9 is that it will show how long a wearer is in a state of atrial fibrillation (AFib) if they have been diagnosed with the condition. The new feature will show the time of day or week that AFib is most active.

You'll receive weekly notifications to help you gain a better insight of AFib frequency. The Health app will show a detailed history, along with indicators of lifestyle factors that may impact the condition, such as exercise, sleep and alcohol intake. You'll be able to download a PDF that includes your aFib history and possible lifestyle factors to share with your healthcare professionals.

Apple Watch's electrocardiogram (ECG) tool can look for signs of an irregular heartbeat or AFib. The US Food and Drug Administration just granted Apple approval last week for an ECG history feature. 

In addition, Apple is introducing a Medications app to help users keep track of when to take their meds.

Developing...

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CVS won’t fill prescriptions for controlled substances from two telehealth companies

CVS will no longer fill prescriptions from telehealth companies Cerebral and Done Health for controlled substances. The pharmacy chain said that, following a review, it had unresolved concerns with both companies. The Wall Street Journal first reported the news.

"We are committed to making mental health services as accessible and convenient as possible. At the same time, it is important that medications are prescribed appropriately," CVS Health's executive director of corporate communications Mike DeAngelis told Engadget. 

"We recently conducted a review of certain telehealth companies that prescribe controlled substance medications. As a result of our being unable to resolve concerns we have with Cerebral and Done Health, effective May 26th, 2022, CVS Pharmacy will no longer accept prescriptions for controlled substances issued through these companies."

The startups have tens of thousands of patients between them, the Journal notes. They have prescribed stimulants such as Adderall for patients with attention-deficit hyperactivity disorder (ADHD). These stimulants are regulated and classed as schedule 2 controlled substances due to the risk of abuse.

Some other pharmacies, such as Walmart and Truepill, previously delayed or declined to fill prescriptions from the two startups. They reportedly had concerns that clinicians at Cerebral and Done were writing too many stimulant prescriptions.

It recently emerged that Cerebral is under investigation by the Department of Justice and the Drug Enforcement Administration. Following that news, the company put prescriptions for ADHD meds for new patients on hold. Cerebral said last week it would stop prescribing most controlled substances for all patients by October. Just two days after that, its board replaced CEO Kyle Robertson.

Along with ADHD, Cerebral says it treats depression, PTSD, anxiety disorders and serious mental illnesses through therapy, counseling and, in some cases, prescriptions. Done focuses on ADHD treatment. 

Before the onset of the COVID-19 pandemic, clinicians were banned from prescribing stimulants without an in-person visit with patients. Those federal rules were loosened in March 2020 for schedule 2 substances, which enabled Cerebral and Done to start offering prescriptions after virtual consultations.

Engadget has contacted Cerebral and Done for comment.

Massive DNA study of human cancers offers new clues about their causes

A team of UK scientists has analyzed the complete genetic makeup of 12,000 tumors from NHS patients and discovered 58 new mutations that provide clues about their potential causes. The team, comprised of scientists from Cambridge University Hospitals and the University of Cambridge, used data from the 100,000 Genomes Project. That's a British initiative to sequence the whole genomes of patients with cancers and rare diseases. 

Team leader Professor Serena Nik-Zainal said this is the largest study of its kind and that the vast amount of data her team worked with allowed them to detect patterns in the genetic alterations or "mutational signatures" found in the tumors. By comparing their results with other studies, they were able to confirm that 58 of the mutational signatures they found were previously unknown. Some of them are pretty common, while some are rare.

"The reason it is important to identify mutational signatures is because they are like fingerprints at a crime scene — they help to pinpoint cancer culprits," Nik-Zainal explained. Some signatures could show that past exposure to environmental causes such as smoking or UV light had triggered the cancer, while others could have treatment implications. They could, for instance, pinpoint genetic abnormalities that could be targeted by specific drugs. 

Professor Matt Brown, chief scientific officer of Genomics England said: "Mutational signatures are an example of using the full potential of [whole genome sequencing]. We hope to use the mutational clues seen in this study and apply them back into our patient population, with the ultimate aim of improving diagnosis and management of cancer patients."

In addition to conducting DNA analysis and publishing its results in Science, the team also developed an algorithm called FitMS that will give clinicians easy access to the new information they discovered. FitMS looks for both common and rare signatures in the results of a patient's whole genome sequencing test. Doctors can use the algorithm to find out if their patients exhibit any of the newly discovered mutations for a more accurate diagnosis and for personalized treatments. 

MIT engineers built a robot for emergency stroke surgeries

Remote robotic-assisted surgery is far from new, with various educational and research institutions developing machines doctors can control from other locations over the years. There hasn't been a lot of movement on that front when it comes to endovascular treatments for stroke patients, which is why a team of MIT engineers has been developing a telerobotic system surgeons can use over the past few years. The team, which has published its paper in Science Robotics, has now presented a robotic arm that doctors can control remotely using a modified joystick to treat stroke patients.

That arm has a magnet attached to its wrist, and surgeons can adjust its orientation to guide a magnetic wire through the patient's arteries and vessels in order to remove blood clots in their brain. Similar to in-person procedures, surgeons will have to rely on live imaging to get to the blood clot, except the machine will allow them to treat patients not physically in the room with them. 

There's a critical window of time after a stroke's onset during which endovascular treatment should be administered to save a patient's life or to preserve their brain function. Problem is, the procedure is quite complex and takes years to master. It involves guiding a thin wire through vessels and arteries without damaging any of them, after all. Neurosurgeons trained in the procedure are usually found in major hospitals, and patients in remote locations that have to be transported to these larger centers might miss that critical time window. With this machine, surgeons can be anywhere and still perform the procedure. Another upside? It minimizes the doctos' exposure to radiation from X-ray imaging.

During their tests, the MIT engineers only had to train a group of neurosurgeons for an hour to use the machine. By the end of that hour, the surgeons were able to successfully use the machine to remove the fake blood clots in a transparent model with life-size vessels replicating the complex arteries of the brain.

MIT professor and team member Xuanhe Zhao said:

"We imagine, instead of transporting a patient from a rural area to a large city, they could go to a local hospital where nurses could set up this system. A neurosurgeon at a major medical center could watch live imaging of the patient and use the robot to operate in that golden hour. That’s our future dream."

You can watch a demo of the machine below:

Yelp expands its restaurant health-grading initiative

Yelp today announced it would further expand its health grades information on restaurant listings. While the reviews platform developed its own digital standard for restaurant hygiene (called "Local Inspector Value-entry Specification" or LIVES) alongside the "the technology departments of the cities of San Francisco and New York" in 2013, it's now broadening its partnership with firm Hazel Analytics. Yelp and Hazel teamed up last year, and together the LIVES metric now incorporates "data from health departments across 48 U.S. states" as well as Toronto and Vancouver.

“The expansion of Yelp's health scores program comes at a time when people are returning to indoor dining as COVID-19 restrictions continue to lift, health inspections are restarting from the early pandemic pause, and restaurants are embracing more diner safety measures like contactless payments and virtual menus,” wrote Yelp in a blog post.

There’s a chance you’ve seen health scores on your city’s Yelp restaurant pages already. But in recent years, Yelp became even more proactive in grading restaurants, going so far as to estimate scores in cases where a city might not issue a letter grade or numerical score. Yelp listings for restaurants in Los Angeles and Chicago also include a rundown of health code violations.

Still, some in the restaurant industry have criticized Yelp’s efforts. Cities and states vary widely in their food inspection scoring, with some assigning a letter grade or numerical score, and others opting for a pass/fail system. Restaurants have complained about inaccurate or out-of-date scores on their listings. The Mercury News reported that restaurants in Bay Area counties that use a pass/fail system were taken aback when Yelp’s algorithm generated its own health inspection score for their businesses.

Yelp calculates health inspection scores using three methods: directly using a score provided by a city’s health department, generating a score from raw health data or using an estimated health score generated by Hazel’s algorithm. The third option — which Hazel defaults to in cases where cities don’t publish health inspection scores — leaves a great deal of room for misinterpretation. And as The Mercury News points out, restaurants that, deservedly or not, show low LIVES-generated scores on Yelp might see their business dry up significantly.

Google seeks FDA approval for Fitbit's passive heart rate monitoring tech

Following a large-scale virtual health study, Google has submitted Fitbit's passive heart rate monitoring algorithm for review by the US Food and Drug Administration. Approval would allow Google to market the Fitbit as a medical device in the States.

The study, which went live in May 2020, was open to all US Fitbit users over the age of 22, and it was designed to test how accurately the device could detect atrial fibrillation, or irregular heart rhythm. The system used photoplethysmography to track the blood flow in a user's wrist and determine if there are any concerning irregularities. Google said its algorithm correctly identified undiagnosed AFib 98 percent of the time in this study, and the company presented its results to the American Heart Association at its most recent meeting.

Fitbit's Sense Smartwatch was approved by the FDA in 2020 for its ability to assess AFib using built-in electrocardiogram technology.

In addition to the Fitbit FDA news, Google is rolling out a few other healthcare-related tools. Google Search in the US will soon show available appointment slots with local doctors and clinics when looking for care, with an emphasis on the CVS MinuteClinic.

"While we’re still in the early stages of rolling this feature out, we’re working with partners, including MinuteClinic at CVS and other scheduling solution providers," Google chief health officer Dr. Karen DeSalvo said. "We hope to expand features, functionality and our network of partners so we can make it easier for people to get the care they need."

Google is also rolling out "health source information panels" and "health content shelves" on YouTube videos in Japan, Brazil and India this week, in an effort to highlight credible information from legitimate sources.