Latest news with #BloodPressure
Bloomberg
5 days ago
- Health
- Bloomberg
WHOOP CEO Says Its Blood Pressure Tool ‘Follows the Law'
00:00 What's your view that the FDA does not have authority in this moment, your wellness, not medical device? Well, thanks for having me on. You know, you've spent the last three years developing a very innovative feature called Blood Pressure Insights, and this takes our wrist worn wearable alongside a calibration with a cuff and is allowed to provide you with a daily estimate of your blood pressure. And in turn, it also then gives you insights how your blood pressure may be affecting other things in your wellness. This could be sleep, stress, nutrition, a variety of different wellness factors. And the FDA is coming forward saying that they believe that this should be regulated. Now, the 21st Century Cures Act makes it very clear that wellness intended features are not supposed to be regulated by the FDA, and the FDA is intended to actually just regulate medical devices that are diagnosing something. So there's this key question of intended use. And you can see this with other physiological metrics like heart rate monitoring, for example, where Hari monitoring has wellness applications and medical applications. The wellness applications might be things like exercise or stress monitoring or sleep monitoring. And we do all that right. And alternatively, there could be, you know, a diagnosis for AFib, and that would be an example where the say, well, well, that's what the FDA misinterpreted of. Right. But you're a smart guy and you employ lots of smart people. Why not just go through the FDA process in the first place kind of foreseeing that this might come up? Well, you have to understand, there's different use cases, right? One use case for blood pressure is around wellness. And there's other use cases that might be a medical diagnosis. And we're certainly looking at, you know, cleared products as well and a longer term horizon. But we're providing a lot of value today and we're following the law again. The 21st Century Cures Act makes it very clear if a product is intended for a wellness use case, it's not supposed to be regulated by the FDA. So then the fundamental question becomes, does blood pressure have wellness intended use cases? We believe it does, right? There's an avalanche of peer reviewed research that shows that blood pressure, not surprisingly, is influenced and influences other aspects of your well, well, why call it medical grade? Why market it that way? Well, we recently came out with the WOOP five data and the BMJ and a key distinguishing factor between the five data and the M.G. is that the M.G. has a medically cleared feature on it. Now, both of those products have a number of wellness features associated with it. The WU PMG happens to have an EKG monitor as part of that that can detect A-fib. And by the way, we spent two and a half years working with the FDA to have that be a cleared feature. So that is the distinguishing factor between those two hardware's. And I want to be very clear in the app, there's an enormous number of medical disclaimers explaining what is for wellness and what is for medical capabilities. Well, you've said this is a misunderstanding. What happens next? Will you continue to fight the FDA on or in the background? Are you trying to reach some solution? We have a lot of respect for the team and we've engaged with them on a number of different features over the years. We think in this specific case they have it wrong and so we're going to continue engaging with them on it. We've responded to their warning letter outlining how we feel about this and why we think we're following the law and we look forward to continuing to engage with them on it. Well, that must take up head space and ultimately your time. How does that impact your future product roadmap? How does more broadly, the FDA acting this way affect innovation more broadly, do you think? Ultimately, I think that, you know, innovation needs to be able to thrive in the United States. WOOP is one of the first wearables in the world that can measure blood pressure accurately from the wrist. That's a really big deal. And it's also being accepted in 50 other markets around the world. So, you know, we want to make sure that there's policies that are consistent here in the U.S. that really allow companies to innovate and to operate. It's also worth noting, you know, we have a lot of people using this every single day. And overwhelmingly, if you look at the feedback from our members, they absolutely love this feature and they talk about how accurate is and how it's helping them understand their wellness. So we feel like we're on the right side of history and we're going to continue educating the FDA on what we're doing. Well well, I'm very quickly I'm not a we use it, but I'm very conscious that in the Premier League and other international football players, it's it's very in the public conscience. I just wonder like is this a good PR moment for you to fight America's regulator? I think in the long run will be on the right side of history and that maybe in a very short period of time, too. I think that fighting for innovation, fighting for Americans access to health data is the right thing to do. And, you know, I've spent 13 years building this company. When I first started, the idea that you could measure sleep or heart rate accurately from the wrist seemed impossible. And now we're able to do blood pressure accurately from the wrist. That's a really big deal. And I think it should be celebrated as long as there's the right guidelines in place and the right education in place for members to understand how to use. And that's what we've done with this feature, and that's why we're proud of it.
Medscape
04-08-2025
- Health
- Medscape
Why Your Arm Shape Skews Blood Pressure Readings
Blood pressure (BP) measurement is a core component of patient assessment in clinical care. It helps guide medication dosing, supports treatment decisions, and is essential for the diagnosis of hypertension. As high BP is often asymptomatic, its accuracy is critical. Measurement errors can lead to misdiagnosis and inappropriate treatment. The Riva-Rocci-Korotkoff method, which uses a cuff sphygmomanometer to measure brachial BP, has been used in clinical practice for more than 100 years. Although BP thresholds and treatments have evolved, this method, which is now built into automated oscillometric cuff devices, remains the standard. It forms the basis of the World Health Organization recommendations and clinical hypertension guidelines. Although this technique may seem simple, it requires multiple steps to ensure accurate and consistent reading. A difference of 5 mm Hg in systolic BP could lead to the misclassification of hypertension in 84 million people worldwide. Measurement Accuracy Sex Differences Recent studies have shown sex-based differences in the accuracy of automated BP measurements compared with intra-arterial BP measurements. At the same intra-arterial BP level, systolic BP measured using an automated cuff was consistently lower in women than in men, suggesting an underestimation of cardiovascular risk in women. This discrepancy may lead to unrecognized undertreatment and could help explain why women face a higher risk for cardiovascular disease at brachial cuff BP levels similar to those of men. Anatomical Factors Anatomical differences may partially explain this variation. Individuals with a large difference between proximal and distal arm circumferences are more likely to receive inaccurate BP readings than those with a more uniform mid-arm shape. Consequently, women are more likely to experience poor fit with cylindrical cuffs that often extend beyond the elbow. Cuff Size Limited data exist on how cuff size affects the agreement between automated and manual BP readings and whether this varies by sex. A study of 3735 participants from the National Health and Nutrition Examination Survey (49% women; average age, 45 years) found that automated systolic BP readings were lower than manual readings. In women, the gap widened with larger cuffs, up to -6.4 mm Hg with extra-large cuffs. In men, underestimation occurred only with extra-large cuffs (-2.4 mm Hg). Differences in arm shape, body size, and adiposity were associated with discrepancies between automated and manual systolic BP readings in both sexes, particularly in extra-large cuffs. The agreement between the automated and manual systolic BP classifications decreased as cuff size decreased from moderate for adults and large cuffs to poor for extra-large cuffs. This pattern was similar in both women and men. Clinical Implications In women, automated systolic BP progressively underestimates manual systolic BP as cuff size increases. In men, this underestimation occurred only with extra-large cuffs. Differences between automated and manual systolic BP measurements were linked to arm size, body size, and adiposity in both sexes, particularly in extra-large cuffs. The agreement in hypertension classification between automated and manual systolic BP declined as cuff size increased, with similar patterns for women and men. The reduced accuracy of automated systolic BP measurements with larger cuffs may lead to inappropriate clinical decisions and requires further study. This story was translated from Univadis Italy.
Khaleej Times
29-05-2025
- General
- Khaleej Times
Hypertension alert: Know your blood pressure, take care of your heart
Hypertension, or high blood pressure, affects over 1.28 billion people globally and is a leading cause of heart attacks, strokes, and kidney failure. Often symptomless, it's known as the 'silent killer,' silently damaging vital organs over time. In the UAE, lifestyle factors like poor diet, stress, and physical inactivity are fuelling its rise, with nearly one in three adults affected. As we mark 20 years of World Hypertension Day, this year's theme — 'Measure Your Blood Pressure Accurately, Control It, Live Longer' — reminds us that early detection, accurate monitoring, and lifestyle changes are key to long-term heart health. 'Your plate can either protect your heart or pressure it,' says Vibha Bajpaiee, Clinical Dietician at Aster Clinic, Bur Dubai (AJMC). 'A diet low in salt, saturated fats, and processed foods, but rich in fruits, vegetables, whole grains, and potassium-rich foods, helps regulate blood pressure naturally. Avoid sugary drinks and excess caffeine. Opt for home-cooked meals with herbs instead of salt for flavour. Keep an eye on food labels — hidden sodium is common. Hydration, portion control, and mindful snacking also play key roles. Combine smart eating with regular movement, and you create a strong defence against hypertension. Remember, what you eat today can shape your heart health tomorrow.' Know your numbers: Why regular BP checks should be your daily habit Dr Heba Tag Eldin, Specialist Cardiology at Aster Clinic, Halwan (Sharjah), says: 'High blood pressure rarely shows symptoms, which is why regular monitoring is crucial.' 'Measuring your blood pressure accurately at home or in a clinic helps detect abnormalities early, often before complications develop. Aim to check at the same time each day, in a relaxed state, and use a validated device. Record your readings to spot trends. Knowing your numbers empowers you to take proactive steps — whether through lifestyle changes or medication. Don't wait for symptoms; prevention begins with awareness. Early action based on accurate readings can help you avoid long-term damage to your heart, brain, and kidneys.' From salt to stress: Blueprint for a heart-healthy lifestyle 'Managing high blood pressure begins with sustainable lifestyle changes,' says Dr Ashik Sasidharan, Specialist Cardiology at Aster Clinic, Al Qusais (Damascus St.). 'Reduce salt intake to less than 5g a day, maintain a healthy weight, and exercise regularly — aim for at least 30 minutes of moderate activity most days. Limit alcohol, quit smoking, and manage stress through mindfulness, breathing exercises, or hobbies you enjoy. Sleep is equally important; poor rest can increase blood pressure. Monitor your intake of caffeine and processed foods, which can trigger spikes. Lifestyle choices may seem small, but collectively, they can significantly lower blood pressure, improve heart function, and reduce your need for long-term medication.' The kidney connection: How high blood pressure wreaks silent havoc 'Hypertension is a major contributor to chronic kidney disease, often causing silent, progressive damage over time,' says Dr Azeem Ahamed, Specialist Nephrology at Aster Clinic, Bur Dubai (AJMC), and Aster Cedars Hospital & Clinic, Jebel Ali. 'When blood pressure remains elevated, it puts extra strain on the delicate vessels in the kidneys, reducing their ability to filter waste effectively. Over time, this can lead to kidney failure. Regular kidney function tests and urine checks can help detect early damage. Managing your blood pressure through diet, lifestyle, and medication is essential to protect kidney health. Hydrate well, limit salt and processed foods, and avoid overuse of painkillers, which can worsen kidney function. Healthy blood pressure supports healthy kidneys — for life.' Pressure builds silently: Early signs you should never ignore Dr Sachin Upadhyaya, Specialist Cardiology at Aster Hospital, Mankhool, says: 'Though hypertension is often symptomless, some people may experience subtle signs like frequent headaches, nosebleeds, blurred vision, chest discomfort, or shortness of breath.' He further explains 'These should not be dismissed. If you're at risk due to family history, obesity, stress, or poor lifestyle habits, regular screening becomes even more essential. Left unmanaged, high blood pressure can silently damage arteries and vital organs. According to the latest 2024 ESC guidelines, even patients with BP above 120/70 mmHg should undergo risk evaluation and begin treatment if found high-risk. If you notice these early indicators, seek medical evaluation immediately. It's better to investigate mild symptoms than wait for a crisis. Timely detection and early intervention can prevent irreversible heart, brain, or kidney complications.' Prepping the heart: Why controlled BP is crucial before surgery Dr Anil P Kumar, Specialist Interventional Cardiology at Aster Hospital, Qusais, says: 'For patients undergoing cardiac or any major surgery, optimal blood pressure control is non-negotiable.' 'Uncontrolled hypertension increases the risk of bleeding, stroke, heart attack, and complications during anaesthesia. Before surgery, a thorough assessment — including blood pressure monitoring—is performed to stabilise the patient. Medications may need adjusting, and lifestyle changes may be recommended in the lead-up to the procedure. Preoperative control of blood pressure improves surgical outcomes, reduces ICU stays, and speeds up recovery. If you're scheduled for surgery, work closely with your healthcare provider to bring your blood pressure within target range well before your operation.' Inside the OR: How surgeons handle hypertension-compromised hearts 'Operating on a heart burdened by years of high blood pressure poses unique challenges,' says Dr Debabrata Dash, Consultant Interventional Cardiology at Aster Hospital, Mankhool. 'Chronic hypertension leads to thickened heart walls, stiff arteries, and a higher risk of bleeding during surgery. Surgeons must anticipate complications like arrhythmias or reduced heart function. Intraoperative blood pressure must be managed meticulously to avoid sudden drops or spikes. Every second in the operating room is calculated, and surgical plans are customised for hypertensive patients. Timely surgical intervention, supported by a multidisciplinary team, helps stabilise cardiac function and prevent catastrophic outcomes. Managing hypertension before and after surgery is vital to long-term recovery.' Post-op and beyond: Managing hypertension after cardiac surgery Dr Srinivasan Kandasamy, Specialist Cardiology at Aster Hospital, Qusais, says: 'Recovery from cardiac surgery doesn't end in the hospital — it extends into daily life.' 'Managing blood pressure post-surgery is essential to protect your surgical outcomes and prevent recurrence. Follow your medication schedule strictly, attend follow-up appointments, and maintain a low-sodium, heart-healthy diet. Gradually return to physical activity under medical guidance. Track your blood pressure regularly and watch for signs like swelling, fatigue, or dizziness. Mental well-being matters too — address anxiety or depression, which can affect your BP. With consistent effort, many patients achieve better blood pressure control post-surgery than before. Long-term success lies in disciplined, proactive care.' At Aster Hospitals and Clinics, we are committed to raising awareness, enabling early detection, and delivering expert care for hypertension. By prioritising accurate monitoring and heart-healthy living, we aim to empower our community to take control of their blood pressure — and their future. Your heart health starts with Aster.
Yahoo
17-05-2025
- Health
- Yahoo
Innovations in High Blood Pressure Intervention Benefit Patients with Resistant Hypertension
World Hypertension Day's focus on High Blood Pressure Awareness, Management and Control highlights Importance of New Therapies, like Ultrasound Renal Denervation from Recor Medical PALO ALTO, Calif., FRANKFURT, Germany, May 17, 2025 /PRNewswire/ -- May 17, 2025, is World Hypertension Day, a day dedicated to raising awareness about high blood pressure, also known as the "silent killer" because many people do not know they have it and, over time, it can lead to serious health issues. The theme of World Hypertension Day, "Measure Your Blood Pressure Accurately, Control It, Live Longer!" highlights the importance of not only awareness but also accurate monitoring, diagnosis, and treatment of hypertension. According to a report from the World Health Organization, the number of adults with hypertension doubled between 1990 and 2019 from 650 million to 1.3 billion. The report also states that only 54 percent of adults with hypertension are diagnosed and only 42 percent receive treatment. And recent studies1,2 have suggested that BP assessment in the clinical setting can often get a hypertension diagnosis wrong or miss it completely. Left undetected or uncontrolled, hypertension is a leading contributor to serious health risks, including heart attack, stroke and kidney disease, making accurate diagnosis, monitoring and treatment of the condition critical. About one-third of the patients who are treated for hypertension remain uncontrolled despite making healthy lifestyle changes and taking more than three medications. For these patients, innovation and investment in new solutions are vital to achieve blood pressure control and realize a healthier future. From pharmaceutical treatments to technology, patients need new therapies that can provide life-changing results. This includes medical device-based therapies, like the Paradise™ Ultrasound Renal Denervation (uRDN) system, an additional treatment option for patients who remain uncontrolled and at elevated cardiovascular risk despite standard lifestyle changes and treatment with oral medications. The Paradise uRDN system is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves.* The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall. This minimally invasive procedure is supported by many medical societies including the American Heart Association, the American College of Cardiology, the European Society of Cardiology and others. "Taking a risk-based approach to hypertension makes sense and this is why the medical societies are increasingly behind it," said Prof. Andrew Sharp, University College Dublin and The Mater Misericordiae Hospital, Dublin, Ireland. "Blood pressure reductions of just 5 to 10mmHg can have a significant impact on the risk of cardiovascular complications, such as stroke and heart attack, but gain is greatest in those who are most at risk, such as patients who also have other risk factors for cardiovascular health such as diabetes. Early blood pressure control may also limit the vascular aging process and yet over half of patients worldwide are not even at the basic standard of control of 140/90mmHg. With guidelines now suggesting lower BP targets of 130/80 for many, new treatments in this space are welcome. Renal denervation is a recently approved tool to safely aid in blood pressure lowering throughout the 24-hour cycle and is independent of patient adherence to medication. The procedure shows an excellent safety profile and typically takes under an hour to perform, with lasting BP reductions demonstrated." Recor Medical – the manufacturer of the Paradise System - has been focused on developing and testing uRDN for the treatment of hypertension since 2009, and completed three independently powered, sham-controlled, randomized clinical trials, all which demonstrate the efficacy and safety of the Paradise System. Recor has also initiated the US Global Paradise System (GPS) Post-Approval Study to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension in the United States. The Paradise uRDN system is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. A physician will make a medical assessment to determine if a patient is a candidate for ultrasound renal denervation. The most common risks include pain, vascular access site complications and vasospasm. Full important risk information can be viewed here. *Anatomies vary. See Paradise IFU for treatment strategies. Liu H et al.: Arm Position and Blood Pressure Readings. The ARMS Crossover Randomized Clinical Trial. JAMA Intern Med. 2024;184(12):1436-1442. doi:10.1001/jamainternmed.2024.5213 About Recor Medical, Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise uRDN system is an investigational device in Japan, is FDA approved in the United States, and bears the CE mark. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise uRDN system in patients with mild-to-moderate and resistant hypertension. In addition, Recor is conducting the Global Paradise System ("GPS") Registry in the European Union and the UK, and has initiated the US GPS post-approval study in the United About Otsuka Medical Devices Co., Medical Devices Co., Ltd. engages in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. ( a global healthcare company listed on the Tokyo Stock Exchange (JP 4578). Photo: View original content to download multimedia: SOURCE Recor Medical Inc.
