Yes, Selena, you are right. It is regulatory issue. And there is a solution to it. But first the background:

I contacted Withings after our first US users brought up this issue to me.

The reason is that the FDA (but not the EMA here in Europe) considers PWV a biomarker, which requires a medical-grade device for its measurement. The Withings scale won't be a medical device in the foreseeable future. Device registration is a very expensive process that would blow the end-user price out of the bounds of affordability.

But the scale still records the PWV. The Withings algorithm then translates it into a range of vascular age (optimal, normal, and not optimal. This range, however, is too broad and the algorithm too insensitive to be used for daily monitoring.

With our LiLo application, we pull the PWV data from the Withings server onto our own server (via API integration). We then use the raw data to translate the Withings PWV into a rate-of-aging score, the fluctuations of which we evaluate with the N-of-1 method for single-subject experiments to monitor the effects of lifestyle interventions. All that is lay-user capable for DIY lifestyle medicine.

With respect to PWV and why it is important to measure, I invite you to read my post in which I explain its foundation in greater detail (https://medium.com/illumination-curated/embrace-your-bioage-abandon-your-calendar-age-say-scientists-7430eff3830f)

So, using our LiLo application (it is a web application, accessible by mobile phone too, but not running as a native app on your mobile, hence not available in app stores).

Now, here is my invitation to you: if you want to buy the scale (Body Comp or higher), and if you want to use the LiLo application free of charge as a beta tester, let me know. You can purchase the scale at any of your preferred online stores. We are not selling it, we have no financial or other ties with Withings. I need to keep LiLo independent and unbiased.

If you want to discuss your participation as a beta-tester further, I suggest you contact me through our website’s contact form (https://www.adiphea.com/en/solutions/contact/). Your inquiry will land directly in my e-mail. Nobody else will see it.

Oh, and thanks for informing me that Australians have the same issue as Americans.