Nokia has announced that it will disable the pulse wave velocity measurement feature on its Withings’ Body Cardio scale as of January 24. The company said it is now learning the technology may require a different level of regulatory approval. However, no specific regulation is cited and the company said the FDA did not recommend or request the removal.
“There was not a specific regulatory issue we encountered,” a representative from Nokia wrote in a statement to MobiHealthNews. “Withings was the first to bring Pulse Wave Velocity (PWV) to a home scale in mid-2016, around the same time as the closing of the Withings acquisition. As a result of a routine product review we proactively made the decision to remove the feature as we evaluate the appropriate regulatory classification in the US. The US FDA has not recommended nor required that Nokia remove pulse wave velocity from the Body Cardio scale.”
Up until the announcement Body Cardio was the only Withings' scale to offer the pulse wave velocity measure, which was one of the key delineating features. Withings defined PWV as "the speed at which heartbeat-generated vibrations spread out along the arterial wall.” At the time of the launch the company also said PWV is a key predictor of hypertension.
The future of the PWV feature is still up in the air. The company told users it is yet to make a decision on if or when it will be reinstated.
The changes are not expected to impact the other scale features like weight, body composition and heart rate. The scale also connects to a tracking app. However, owners hoping to opt out of the changes are out of luck, it is not optional; come Thursday January 24th the feature will be remotely removed from all scale.
The PWV scale is being removed from every Body Cardio scale regardless of country, but the company did not cite a specific international regulation either.
“We engage with regulatory bodies in all the countries where we sell our products when and as appropriate,” a Nokia reprsentative wrote to MobiHealthNews. “We have notified the US FDA about our decision to deactivate the PWV feature from the Body Cardio scales. We will notify other relevant regulatory bodies if and when appropriate. To date, we have not.”
The scale which is listed at $179.95, is currently unavailable for purchase but the company promises to resume shipment in the first few months of the year. Nokia is offering to fully refund the product if customers return their scale or a $30 coupon if they do not.
Despite the refund, the “Ask Nokia Health” Twitter page was buffeted with complaints from users all over the world since the announcement. Several product reviews on Amazon have also complained about the PWV feature removal—many calling the product overpriced without it.
"It was a decision that wasn't taken lightly," a Nokia representative said in an email to MobiHealthNews. "Nokia places great importance on the quality and reliability of its products and compliance with the current regulations. If we feel that any product does not meet these high standards, we take prompt action. With Body Cardio, we concluded that PWV may require a different level of regulatory approval in the US; given the lack of clear guidelines on the use of PWV as a measure of general wellness at home. We are being cautious and proactive by disabling the capability on the scale."
Body Cardio was first launched in 2016 and is a fourth generation of Withings scales. Nokia Technologies spent $191 million to acquire Withings in May of 2016.
Without the PWV feature, many (including Nokia itself in a FAQ about the news) are asking how the scale now differs from other Body+ scales, which retail for around $80 less than the Body Cardio.
"Body Cardio uses advanced technology to provide accurate weight measurement, measurement of body composition and standing heart rate measurement, as well as a sleek profile, and rechargeable battery," the company wrote. The scale is 0.7 inches think and promises a one-year battery life.
“Body Cardio is the most advanced device we have ever made," CEO Cedric Hutchings said in a statement when the product first launched. "Body Cardio redefines how people use connected scales, providing them with a tool to manage their weight as well as heart health. It is like getting information from your annual physical every day.”
The move could be related to recent changes in FDA's guidance pertaining to medical devices, which dropped in December. One guidance deals with the line between consumer wellness devices and medical devices. Another deals with the regulation of clinical decision support software.
“These publications come as part of the FDA’s effort to improve its approach to digital health, to continue to work on drawing the line between digital health tools that are properly regulated as 'devices' by the FDA and those that are not,” David Harlow, an attorney and digital health expert wrote in his blog. “Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.”
One of the drafts named the Cures Act Guidance calls on the agency to clarify that its jurisdiction doesn’t apply to lifestyle apps as long as they aren’t designed for diagnosing, treating, mitigation or prevention of a disease, according to Harlow. Among the examples are weight management, physical fitness and relaxation, or stress management apps. KD VIII Elite High