Why is Withings reactivating Pulse Wave Velocity (PWV) on Body Cardio?
In 2016, we launched the first personal scale on the market with a PWV measurement. With this innovative metric, consumers could see an indicator of their overall cardiovascular health simply by stepping on their scales, without changing their daily routines—empowering them to make the right choices to improve their health over time. We feel this unique at-home metric helps us go further in our mission to give people the right tools to improve their long-term health. We believe that this feature is a game-changer, which is why we’ve been working with the appropriate regulatory bodies to guarantee that when it is reactivated, no further regulatory approval is required.
We received many requests from our users asking when this innovative feature would be made available again on their scales. We are delighted to announce that the feature is available once again to all users who have bought a Body Cardio in Europe.
Why didn’t you reactivate it before?
We brought the PWV feature to a home scale for the first time with Body Cardio. Last year, we made the decision to turn off this feature, because the scale’s capabilities in the area of measurement of PWV may have required a different level of regulatory approval. Since then, we have carried out an in-depth internal audit on this measurement and its capabilities for consumers. In addition, we have worked closely with local regulatory bodies and are now in the position of guaranteeing that no further regulatory approval is required to reactivate the feature in Europe.
Why is the feature only reactivated in Europe for now?
PWV measurement requires different levels of regulatory approval depending on each country. Whereas we have completed the discussions with European regulators and can thus guarantee that no further regulatory approval is required for the EU, we are still working on getting clearance in other countries to be able to reactivate the feature, including working with the FDA in the U.S.
Will it also be reactivated to the users based in the US?
We are currently working closely with the FDA, and we aim to bring back the feature to our U.S. users in the foreseeable future.
Who have you been talking to in Europe to reintroduce Pulse Wave Velocity?
Since we first launched Body Cardio in 2016, we have been in conversations with the ANSM (Agence Nationale de la Santé et du Médicament), in order to define the right regulatory framework and adapt our communication to consumers to its non-medical use.
Will it also be reactivated to the users based in Japan?
We are currently working closely with the local Japanese authorities, and we aim to bring back the feature to our Japanese users in the foreseeable future.
Is PWV measured differently than before?
Body Cardio measures PWV the same way as before. Results on the app are displayed with a color-coded graph and come with in-app advice that can possibly help reduce the user’s PWV over time, and improve overall well-being.
How is the feature reactivated on my scale?
The feature will be automatically reactivated for users who have bought a Body Cardio in Europe via an automatic update if the scale is connected via Wi-Fi.
Users who only synchronize their scale via Bluetooth will need to weigh in and sync the data with their Health Mate app. They will then get the PWV measurement during their next weigh-in.
I have a Nokia branded Body Cardio, is the feature also reactivated on my scale?
The feature is available again on all Body Cardio devices bought in the EU, whether they are Nokia- or Withings-branded (current and new users).
Will I have access again to my previous PWV data?
Yes, previous PWV data will be available. It will be shown in your Health Mate app and in the Health Mate Online Dashboard.
Why is PWV used by the medical community?
Risk factors such as blood pressure, diabetes and cholesterol, and assessment of pulse wave velocity are used by the medical community to provide a more complete picture of overall cardiovascular health.
An elevated PWV is a sign of arterial stiffness and indicates a risk of having or developing hypertension. On the other hand, the more flexible the artery, the better your heart health.
Medical research has demonstrated a strong correlation between the stiffness of the arteries and the risk of a cardiovascular incident. Stiffer arteries indicate a greater risk of high blood pressure, stroke, or heart attack.
Why include PWV measurement function into a scale?
The medical value of PWV in assessing cardiovascular health is proven, but the complexity associated with collecting measurements means that PWV is traditionally restricted to a clinical setting. Body Cardio brings this measurement home, so consumers can see an indicator of their cardiovascular health just by stepping on their scales, helping them to make the right choices to improve health over time.
Is Body Cardio a medical device?
Body Cardio is not a medical device and doesn’t detect, prevent, monitor, or treat a disease. The scale, via PWV computation, gives you an indication of your cardiovascular health as well as tips to develop healthier habits to improve your long-term health outcomes. It is to be used as a tool to track how your positive lifestyle choices are affecting your cardiovascular health, allowing you to make better choices and enjoy better health over time.
Is Withings planning to certify Body Cardio as a medical device in the future?
We are not planning to certify Body Cardio as a medical device, as Body Cardio is not intended to detect, prevent, or treat a disease. The scale, via PWV computation, gives you an indication of your cardiovascular health as well as tips to develop healthier habits to improve your overall long-term health.
Is your PWV measurement reliable?
To assess the validity of the measurement of Body Cardio, Withings has performed validation studies in collaboration with hospitals (Brigham and Women’s Hospital, Boston / Hôpital Européen Georges Pompidou, Paris / Scripps Institute, San Diego). These studies compared the measurement of the PWV measurement made by Body Cardio to those taken with a medical device used to measure PWV. The results of the studies demonstrate that PWV measurements taken with Body Cardio yielded similar results to measurements taken using the reference medical device.
Which firmware will bring back the PWV?
The PWV feature is available with the firmware 1811.
Which app versions can display the PWV?
The PWV feature is available with Health Mate 4.4.1 for iOS and Health Mate 4.3.4 for Android.
How to explain a discrepancy between past and new data (if there is)?
Various factors can lead to variations in blood pressure and PWV, such as time of the day, coffee consumption or stress level. The best way to have an accurate indication of your cardiovascular health is to measure your PWV over time.
Will I get the feature if I purchase the scale in Europe but I live in the US? Will I get the feature if I purchase the scale in the US and live in Europe? Will I get the feature if I purchase the scale online, from a US retailer, such as amazon.com?
Will the price of Body Cardio increase?
No. We are delighted to bring back to our European consumers an innovative feature that was much awaited.