Author: books

VUNO scores government approval for at-home ECG device

Medical AI developer VUNO has received the approval of the Ministry of Food and Drug Safety (MFDS) for its at-home ECG device.

Called Hativ P30, the medical device not only provides a 6-lead heart signal measurement within 30 seconds, but it also analyses data to check for sinus rhythm, atrial fibrillation, bradycardia, and tachycardia. 

The device is VUNO’s second product release under its integrated health management brand, Hativ. Hativ Pro, its first personal ECG device, was awarded an MFDS certification in July.

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Life insurer Max Life launches analytics solution for insurance underwriting

India-based Max Life Insurance Co. has developed and launched a health analytics solution for insurance underwriting.

Called MediCheck, the application uses digital health records from diagnostics centres to detect inaccurate medical reports in real time. It can also provide health scores of insurance customers. 

The underwriting solution was developed to minimise the instance of claim repudiation and enable faster claims processing, said Max Life COO and director Manu Lavanya.

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Samsung targets to screen 150,000 Indians for eye diseases using upcycled phones

Using upcycled phones, Samsung is targeting to screen about 150,000 individuals in India for eye diseases by the end of 2023.

The global technology manufacturer has been transforming old Galaxy devices into fundus cameras through its Galaxy Upcycling programme. The EYELIKE fundus cameras use AI to detect diseases in scanned retinal images.

The company has partnered with four eye hospitals – Sitapur Eye Hospital, Aravind Eye Hospital, Guruhasti Chikitsalya, and Dr Shroff’s Charity Eye Hospital – to set up eye care camps and use the upcycled devices to screen people for eye diseases.

Noom confirmed another round of layoffs at the digital weight loss company this week, the latest in a spate of workforce reductions at health tech companies.

According to reporting by TechCrunch, Noom let go of about 500 workers, or around 10% of its staff, largely affecting its coaching team. 

This marks the second round of layoffs at the company this year. Insider first reported in April that Noom was cutting about a quarter of its coaches as part of a strategy change in its coaching model. 

“Noom has experienced extraordinary growth over the past several years, and it’s essential that we are structured in a way that enables us to continue growing over the long term. We recently made the difficult decision to reduce the number of Noom employees. We are deeply grateful for their contributions to Noom, and we wish them continued success,” a Noom spokesperson wrote to MobiHealthNews.

THE LARGER TREND

Founded in 2008, Noom raised a massive $540 million Series F round in 2021. At the time, Bloomberg reported it was valued at $3.7 billion. The company said it planned to use the cash to expand outside weight loss and later launched a stress management product dubbed Noom Mood. 

But Noom has faced pushback for its weight loss model, which some have critiqued for too-low calorie recommendations and insufficient support from coaches with high caseloads. 

Earlier this week, TripAdvisor announced the hire of Noom CFO Mike Noonan, who will take over for its retiring executive at the end of the month. The company is also looking for a new CEO to replace cofounder Saeju Jeong, who is staying in his role until Noom finds a successor. 

A number of other digital health and health tech companies have announced layoffs this year. Connected fitness giant Peloton recently laid off another 500 workers, its fourth round of reductions this year as the company executes a financial turnaround plan. 

COVID-19 testing and vaccination startup Curative announced it was laying off 109 workers last month as it shifts focus to launching a new health plan. 

Oct. 14, 2022 — Spending time in “blue spaces” — such as beaches, rivers, and lakes — as a child can have significant and lasting benefits for wellbeing throughout life, according to a new study published in the Journal of Environmental Psychology.

When exposed to blue spaces in childhood, people are more likely to revisit bodies of water in adulthood and appreciate the time spent in natural settings.

“Learning to swim and appreciate the dangers in terms of rip currents, cold temperatures, etc., is of course primary,” Mathew White, one of the study authors and a senior scientist at the University of Vienna, told The Guardian.

“But the message we are trying to get across is that to only teach children about the dangers of water settings may make them overly afraid of, and ill-equipped to benefit from, places that can also be hugely beneficial to their health and wellbeing as they grow up,” he said. “The vast majority of blue space visits — both for adults and children — do not involve getting wet, so there are also many advantages from spending time near water, not just in it.”

Researchers from the U.S. and a dozen other countries analyzed data from the BlueHealth International Survey for more than 15,000 people across 18 countries, examining the links between childhood exposure to blue spaces and adult wellbeing. 

Participants recalled their experiences up to age 16, noting how often they visited blue spaces, how local they were, and how comfortable their parents or guardians were about allowing them to swim and play. They also discussed their recent contact with blue spaces and green spaces during the previous four weeks, as well as their mental health status during the previous two weeks.

Researchers found that more childhood exposure to blue spaces was associated with better adult wellbeing. They noted the results were consistent across all countries and regions.

Adults also had familiarity with and confidence around coasts, rivers, and lakes, as well as higher levels of joy around bodies of water and a greater propensity to spend recreational time in nature during adulthood. In turn, this lifted their mood and wellbeing.

“We recognize that both green and blue spaces have a positive impact on people’s mental and physical health,” Valeria Vitale, one of the study authors and a doctoral candidate at Sapienza University of Rome, told The Guardian.

In recent years, a growing number of studies have noted the benefits of spending time in nature, including both blue spaces and green spaces such as forests, parks, and gardens. The natural settings can increase people’s physical activity levels, boost mood and wellbeing, and lower stress and anxiety. 

Vitale and colleagues noted that blue spaces, in particular, have unique sensory qualities such as wave sounds and light reflections that can improve mood, as well as leisure activities such as swimming, fishing, and water sports.

“We believe our findings are particularly relevant to practitioners and policymakers because of the nationally representative nature of the samples,” she said. “First, our findings reinforce the need to protect and invest in natural spaces in order to optimize the potential benefits to subjective wellbeing. Second, our research suggests that policies and initiatives encouraging greater contact with blue spaces during childhood may support better mental health in later life.”

Calif.-based virtual healthcare provider HealthTap and multinational electronics company Samsung announced a strategic partnership to bring virtual healthcare to Samsung Smart TVs in the U.S. 

HealthTap is a technology company and medical group providing virtual healthcare offerings via the web and health apps. 

The partnership extends HealthTap’s services to Samsung TV owners, who will be able to connect to HealthTap’s healthcare platform and visit with a health provider via a connected television camera.

Consumers can review a doctor’s bio and credentials, watch video interviews to designate their preferred doctor and then schedule an appointment to see the provider. 

“Developing a primary care relationship is critical for all Americans, and the ability to conveniently access telemedicine through a TV screen empowers everyone to take care into their own hands,” Sean Mehra, CEO and founder of HealthTap, said in a statement. 

THE LARGER TREND

This week, Samsung also announced its aim to screen 150,000 Indians for eye disease by the end of 2023 using upcycled phones.

The technology manufacturer is modifying old Galaxy devices into fundus cameras via its Galaxy Upcycling program. The EYELIKE fundus cameras utilize AI to detect diseases in scanned retinal images.

Research of the Week

Preliminary evidence that long COVID might be psychological in nature, and that the physical symptoms can be alleviated or even cured by therapy. Great news.

Unprocessed red meat vindicated, again.

How caffeine affects mitochondrial biogenesis.

Micronutrient deficiencies are still widespread and affect primarily children and fertile women.

Dad’s stress levels seem to affect children’s development.

New Primal Kitchen Podcasts

Primal Kitchen Podcast: The Link Between Dairy Intolerance and Dairy Genes with Alexandre Family Farm Founders Blake and Stephanie

Primal Health Coach Radio: Mindful Weight Loss with Lucia Hawley

Media, Schmedia

Top Manchester United soccer player has a familiar diet.

“Best Before” labels, of dubious utility, are responsible for a huge amount of waste.

Interesting Blog Posts

The story of the carnivore who ate potatoes.

Just what are fungi doing in tumors?

Social Notes

Nonsense.

Everything Else

10 hour eating windows work for overweight women.

Snow crab season is canceled.

Things I’m Up to and Interested In

Gee I don’t know: Why do so many health influencers talk about seed oils now?

Awesome to see: The Department of Defense grants millions to study ketones in the military.

Interesting research: Early bedtimes may lead to better metabolic health.

Nature is healing: Britain falls back in love with butter.

More circadian food timing research: Eating more calories in the morning is associated with less subjective hunger than eating more at night.

Question I’m Asking

When do you go to bed?

Recipe Corner

Time Capsule

One year ago (Oct 1 – Oct 14)

Comment of the Week

“Thank you for your comments regarding sex segregation in sports. As a father of 4 daughters who have competed at high levels in different sports and as a previous doctor for the us spseedskating programs, i would like to advise some thoughtful caution Female sports in the USA are thriving due to 40 years of mandated “equal access.” Gaps in performance between male and female in many sports are narrowing, especially endurance sports. However, testosterone (and other) intrinsic differences in hormone levels make for an uneven playing field. Female athletes and their families work just as hard, sacrifice just as much as male athletes to achieve their competition goals. We need to be very careful about eliminating fairness for the many to make it fairer for the few. Perhaps with more time and sport evolution, gender requirements can be fairly dispensed with. But not quite yet..”

-Nice comment.

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Oct. 14, 2022 — Patients with type 2 diabetes achieve much better control of their blood sugar if they participate in mind-and-body-practices such as yoga, a new study shows.

While past research has been done specifically for yoga, this study, published online recently in the Journal of Integrative and Complementary Medicine,  also looked at the benefits of other mind-and-body practices for these patients, including qi gong and meditation.

The study is “the first to show that there is a very consistent effect [on hemoglobin A1c, a marker of diabetes] regardless of which modality you use,” says one of the researchers, Richard Watanabe, PhD. 

“So I think one of the important messages … is that any sort of mind-body intervention seems to be helpful, which makes this a much more flexible tool than telling a patient that they should [just] do yoga,” says Watanabe, who is a professor of population and public health sciences at the University of Southern California’s Keck School of Medicine in Los Angeles. 

There are other options available, “and if you are a busy person and getting to yoga is not doable, you can learn about meditation and do it anywhere. So again, it [is] … a flexible tool to help their patients with blood sugar control,” he says. 

“The most surprising finding was the magnitude of the benefit these practices provide,” says the lead author, Fatimata Sanogo,  from the University of Southern California, Los Angeles, in a statement. “We expected there to be a benefit but never anticipated it would be this large.” 

But how do mind-body practices reduce A1c? It’s not totally clear, Watanabe says, noting that more research needs to be done to figure this out. 

“But I think everyone’s hypotheses is that these methods reduce stress, so the idea is that they reduce stress hormones and since these hormones do have an effect on glucose metabolism, reducing them using these modalities reduces A1c and blood sugar levels,” he explains. 

Alternatively, mind-body practices might improve insulin sensitivity. “You basically allow insulin to be more efficient at increasing glucose uptake by insulin-sensitive tissues,” Watanabe says. 

So should doctors prescribe any one of the mind-body practices looked at in the study? Maybe, Watanabe says. 

“Our results suggest that the effect you are going to see with the mind-body intervention is going to be on top of whatever standard of care patients are getting, so it definitely cannot hurt,” he says. He also notes that for patients with diabetes, constantly having to monitor their blood sugar levels and watch what they eat is very stressful. 

“That just contributes to the difficulty in controlling blood sugar,” he says. “So I think physicians need to evaluate their patients and help them pick the thing that fits best with their lifestyle and personality, so it’s really up to the physician to work with patients and help them find something that works for them.”  

A Study of Studies 

The researchers conducted what is known as a meta-analysis, where they identified 28 studies, published between 1993 and 2022, looking at the use of mindfulness practices in patients with type 2 diabetes. 

All studies excluded patients who needed insulin to control their diabetes as well as those with medical complications such as heart disease or kidney complications. The types of mind-body practices analyzed included meditation, breathing techniques, yoga, and an ancient Chinese practice known as qi gong, a type of slow-moving martial arts that’s similar to tai chi. 

Using hemoglobin A1c (HbA1c) as a test that tells patients what their average blood sugar levels have been for the last 3 months, the results showed that the overall reduction in average A1c was 0.84 percentage points. 

And reductions in A1c were seen with all types of mind-body practices. In patients who practiced mindfulness-based stress reduction, A1c was reduced by a mean of 0.48 percentage points. This practice involves focusing on one’s breath and on a particular thought, object, or activity to engender a stable emotional state and be fully present and aware of one’s surroundings. 

The practice of qi gong also reduced A1c by a larger degree of 0.66 percentage points. 

But the reduction in A1c was largest among those who practiced yoga, at 1.0 percentage points — about the same degree of reduction in A1c that’s seen with metformin, a drug widely used to treat type 2 diabetes around the world.

In fact, for every additional day of yoga practiced each week, the mean A1c differed by -0.22 percentage points over the study period. 

Fasting blood sugar also improved significantly with mind-body practices. 

Overall, the average reduction in A1c and fasting blood sugar “was clinically significant, suggesting that mind and body practices may be an effective, complementary nonpharmacological intervention for type 2 diabetes,” the study authors said. 

In late September, the FDA released its final report on the Software Precertification (Pre-Cert) Pilot Program, which it launched in 2017 to explore different regulatory approaches for digital health tools.

By 2022, the agency determined a new regulatory framework would be useful for software as a medical device, but it couldn’t do that alone.

“We are not fully capitalizing on these capabilities and approaches for software in the current statutory and regulatory framework for medical devices,” the FDA wrote in its report. “Based on these observations from the pilot, FDA has found that rapidly evolving technologies in the modern medical device landscape could benefit from a new regulatory paradigm, which would require a legislative change.”

David Rosen, a partner and public policy lawyer at Foley & Lardner, notes there have been big changes in the digital health space in the past five years, including advances in consumer wearables and tools that aim to guide clinician decisionmaking. He sat down with MobiHealthNews to discuss the pilot program and how digital health companies should approach the regulatory process.

MobiHealthNews: What were some of your big takeaways from the Pre-Cert pilot?

David Rosen: The whole idea behind the Pre-Cert program was to look at different regulatory approaches to try to assist companies in developing software for use as a medical device. And it was predicated on companies making sure that they have a robust quality organization and organizational excellence, and that they do some real-world monitoring of the software as it’s being used. 

In general, I think that’s a very appropriate goal and a good goal for the FDA to consider, because this is the evolution of how healthcare is being delivered. The model is evolving, and we have this new paradigm, and I think the FDA has to be open to shifting how they regulate things outside of the normal scope of traditional medical devices that they typically see. 

You saw the report from Sept. 22, and there were a few limitations. There were only a few devices available for consideration. There were nine participants. But the FDA didn’t want to have a significant number of products going through the De Novo process, because they didn’t know how that process was going to work. So that was kind of a very interesting little situation for the FDA to evaluate. 

Again, the whole idea behind the pilot Pre-Cert program was to help companies and help the FDA better understand the design and development and management of digital health products. So I think that the Pre-Cert program did help with that. But I think the bottom line is that the FDA decided that the current regulatory paradigm isn’t going to work for this, and that they need a different FDA regulatory pathway and review process to deal with software as a medical device.

MHN: So what do you think digital health and health tech companies should take from this program and these results?

Rosen: First, they need to watch what the FDA is going to be doing in the future. This culture of quality and organizational excellence though, in terms of verification and validation of software, is really, really important. 

I’ve worked on a lot of these products, and you see companies have different approaches in how they want to verify and validate the usefulness of the data. And I think that we have to be very circumspect, and the companies have to be very circumspect, and they need to work and educate the FDA on how their program works and why the metrics are appropriately valid to come up with some sort of treatment decision. It needs to be a cooperative approach between the industry and FDA to move this whole situation forward to help bring new products into the marketplace.

MHN: You previously worked at the FDA. What are some of the big challenges that you see when it comes to regulating software?

Rosen: The whole pandemic situation has really made it very difficult, because CDRH [Center for Devices and Radiological Health] has been really inundated with COVID-19, in-vitro diagnostic tools and things like that. It was a lot better when we could do things in person. We could have a meeting, and we could do a demonstration, and we could have more interactive dialogue with the FDA. I think those are the kinds of things that really help both the FDA understand what industry is doing, and then help the industry understand and appreciate FDA expectations as to how to develop these products.

MHN: I also wanted to ask about the FDA’s recent guidance on clinical decision support software qualifying as medical devices. What do you think this signals about the FDA’s process right now?

Rosen: Anytime that the FDA is issuing guidance, we look at what the motivation was for issuing those guidances, how much experience that the agency has had, and the regulatory process at this stage. 

I think they’ve seen a number of people coming out with clinical decision support software. I think it’s important to level-set the expectations associated with that software and to ensure that it’s helpful to the industry, to say “Hey, this is what FDA is thinking, this is what the expectations are.” It doesn’t necessarily mean to set out a rigid approach to what you have to do. But it certainly sets forth what FDA is thinking about.

I think it’s a very positive situation when you see the agency moving forward, issuing these types of guidances. They’re thinking about these things, and we will have a better regulatory understanding and regulatory scheme in the future for these types of innovations in healthcare, which I think is really important at this stage.