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US FDA to limit regulation of health and fitness wearables, commissioner says

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US FDA to limit regulation of health and fitness wearables, commissioner says

Jan 6 (Reuters) – The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to clarify its regulatory approach.

The guidance, along with comments from FDA Commissioner Marty Makary, adds to existing policy that classifies low-risk wellness tools, such as fitness apps and activity trackers that encourage exercise, as non-medical devices exempt from stringent regulation, provided they do not make claims related to disease diagnosis or treatment.

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“We have to promote these products and at the same time, just guard against major safety concerns,” Makary said in an interview with Fox Business about artificial intelligence software such as ChatGPT, adding that “if people are looking up a symptom on an AI-based tool, let’s have that conversation when they come in to see their doctor or do a virtual visit.”

Shares of continuous glucose monitor manufacturers Abbott (ABT.N), opens new tab, Medtronic (MDT.N), opens new tab and Dexcom (DXCM.O), opens new tab closed between 1% and 4% higher. U.S.-listed shares of fitness smartwatch maker Garmin (GRMN.BN), opens new tab ended nearly 3% higher.

“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” Makary told Fox Business.

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“The only stipulation is if they make claims of something being medical grade … like blood pressure measurement. We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter.”

Last year, the FDA issued a warning letter to fitness band maker WHOOP, saying its blood-pressure insights feature blurred the line between wellness and medical devices by estimating systolic and diastolic values used to diagnose hypertension.

The agency also sent out a broader warning to consumers about the risks posed by unauthorized devices.

Reporting by Puyaan Singh in Bengaluru; Editing by Peter Henderson and Sherry Jacob-Phillips

Our Standards: The Thomson Reuters Trust Principles., opens new tab

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Fitness

I’m a Pilates instructor – planks are great, but this roll-up exercise improves core strength and control more efficiently

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I’m a Pilates instructor – planks are great, but this roll-up exercise improves core strength and control more efficiently

Pilates can be a game-changer for core strength, and the plank exercise is a popular exercise that many instructors include in their training. It has all the benefits for strength and stability, but if you’re anything like me, you’ll have a love/hate relationship with the move. So, imagine my delight when an instructor told me about how effective roll-ups can be in a bodyweight Pilates workout.

Pilates roll-ups involve lying on your back, slowly raising your back off the ground, and coming up to a seated position, explains Helen O’Leary, a certified Pilates instructor at Complete Pilates. She’s a big fan of the exercise as it stretches the intercostal muscles in your back while engaging your upper and lower abdominal muscles and your obliques.

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We Tested More Than A Dozen Popular Fitness Trackers—Our Favorite Is $120

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We Tested More Than A Dozen Popular Fitness Trackers—Our Favorite Is 0

After testing a dozen fitness trackers, the Fitbit Charge 6 won a gold star for its premium features at an affordable price point of $120. The price also includes a six-month membership to Fitbit Premium, which features a library of cardio and strength training workouts and a monthly analysis of 10 sleep metrics—that’s an easy sell! The Charge 2 was my first ever fitness tracker, so I have a soft spot for the Charge line. Instead of manually recording workouts, it automatically records movement such as walking, swimming, and biking, which is nice instead of fiddling around with a watch interface (although it’s a simple swipe). Speaking of swimming, the tracker can be submerged in water up to 50 meters so I never have to take it off when showering.

It has a sensor on the back of the slim rectangular watch case to track heart rate, which never disrupts my range of motion during weight lifting or mat Pilates. When comparing against higher-end models like the Garmin Vivioactive, my heart rate data matched up, which proves its lower price tag doesn’t equal lower quality. Aside from heart rate, stress levels, period, fertility insights, and sleep are also tracked.

I’m not a fan of wearing a watch to bed, but this model is so lightweight (30 grams) and thin that I barely notice it. It provides a sleep score breakdown of all your cycles and whether or not it was optimal for recovery, which is especially helpful if you’re in the process of training for a race or going hard at the gym. Your duration of sleep is also recorded, but I found it recognizes sedentary activities such as watching TV as sleeping, which got on my nerves slightly. Post-snooze, it delivers a personalized daily readiness score, which shows if you’re ready for a sweat sesh.

It pairs perfectly with Android smartphones, given that Google owns Fitbit (a Google account is also required to set up). It seamlessly interacts with calendar and weather apps, plus you can receive texts, notifications, calls, and access Spotify. Fitbit Pay is built in, too, for easy access to cardless payments.

The biggest con with the Charge 6 is that the battery drains fast. Fitbit says it lasts up to a week, but I found it needs to be charged by day four. It’s not a huge deal, just make sure to carry a charger if you’re traveling. As for the warranty, it lasts one year and provides coverage in the event the hardware is defective, so make sure you don’t lose it!

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Read More: Best Workout Apps

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How Heidi Klum stays fit and strong at 52 – ‘I never exercise too much’

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How Heidi Klum stays fit and strong at 52 – ‘I never exercise too much’

Heidi Klum has been highly active throughout her career, but nowadays she prefers to rely on her lifestyle to keep her fit incidentally rather than on dedicated gym sessions.

The 52-year-old supermodel counts keeping up with her family as her primary form of movement. ‘I run around a lot, having four kids. I have a younger husband,’ she told Us Weekly. ‘I get plenty of movement from running around after two dogs and a cat,’ she added to the Daily Mail.

This kind of non-intentional or informal activity is known as Non-Exercise Activity Thermogenesis, or NEAT. It can include housework, walking, taking the stairs instead of the lift, carrying the shopping instead of using a trolley, gardening and even fidgeting.

NEAT makes up between 15 – 50% of your total daily energy expenditure (TDEE) – how many calories you burn throughout the day, says Hannah Baugh, nutritionist and sports performance nutritionist at Hannah Rose Nutrition. By contrast, formal exercise like a workout class or going for a run makes up around 5-10% (though this varies between individuals).

Calorie burning is a big benefit, but there’s considerably more to it. It can also help build cardiovascular fitness and muscle as you lift and carry things and move, and for Heidi, it’s convenient and sustainable, meaning she can stay consistent.

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‘I never over-exercise or lift heavy weights,’ she explained. ‘People often push themselves too hard. I listen to my body. I have no back or knee pain. I eat right.’

Adding that she doesn’t ‘really exercise’ that much, she said, ‘I don’t think you have to do a lot, but if you do a little bit [regularly], that’s important’.

Heidi’s low-impact exercise routine

When she does incorporate formal exercise into her day, Heidi prefers more low-impact, joint-friendly movements that she can do on the go.

At the beginning of this year, she shared a video of herself performing bicep curls with resistance bands by the pool. Generally, bands are gentler on your joints compared to dumbbells as they start with very little resistance and increase gradually as the band stretches – the weight isn’t fixed. In contrast, a dumbbell requires you to bear a fixed weight from the start of the movement. There’s also less stress on the way down (eccentric) with a band as the tension releases as you return.

‘Bands create constant tension through the full range of motion, and they’re light enough to throw in a suitcase, so ideal for someone like Heidi who is constantly travelling,’ agrees Daniel Booth, high-performance coach and consultant, and the co-founder of MyoLab Performance Concierge. ‘Anyone can do this at home to build their biceps and triceps without a lot of equipment.’

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He stressed the importance of lifelong resistance training. ‘After 40, women lose muscle faster, oestrogen drops and their metabolism shifts, meaning they gain weight easier, making training consistently like Heidi especially important.’

Heidi’s previous training routines

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Heidi’s preference for low-impact movement extends back to the covid pandemic. ‘I jump on the trampoline in the garden at my home in LA and do bodyweight exercises – including lots of squats,’ she said to Daily Mail about her routine. The one exception would be running – a high-impact activity that places stress on your bones – which she counted as her main form of cardio.

As a Victoria’s Secret Angel, Heidi was known to work out with celebrity trainer David Kirsch, whose sessions involved more conventional weight-based gym training.


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Daniel Booth is a high-performance coach and consultant, and the co-founder of MyoLab Performance Concierge, which cultivates excellence within elite performers, working on everything from strength and conditioning to injury-risk reduction and competition preparation. He previously led performance management as head coach at Warner Bros. and Watford FC Women. Find him on Instagram.

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