The device, called the Body Scan 2, will cost US$600 in the US, making it the company’s priciest smart scale yet. — Withings
Withings, the French company that pioneered the category of WiFi bathroom scales, unveiled a new top-of-the-line model that monitors signs of hypertension, the latest in a wave of consumer health gadgets attempting to help manage high blood pressure.
The device, called the Body Scan 2, will cost US$600 in the US, making it the company’s priciest smart scale yet. In addition to sending notifications about hypertension risk, the scale has a new feature designed to measure heart pumping efficiency, Withings said Sunday in a statement. It can also look for signs of glycemic dysregulation, a potential precursor toward prediabetes. Users can opt in to monitoring certain metrics, and the tracking then happens automatically when they step on the scale. The most extensive scans can take 90 seconds depending on the setup, Withings said.
It’s expected to go on sale in the second quarter, pending clearance from the US Food and Drug Administration. It will also be available in the UK, Australia and Europe. The original Body Scan, which went on sale in the US in 2023, will remain on the market for US$500.
Modern consumer health gadgets have increasingly been blurring the lines between a fitness tracker and medical tool. Hypertension, or high blood pressure, has been an especially keen area of focus for many of the hardware companies in this space, including Apple Inc and Samsung Electronics Co, both of which offer blood pressure tracking in some of their newer smartwatches.
Whoop Inc, which makes popular screenless fitness bands, offers a similar feature on its higher-end model, the MG – short for "medical grade.” The company has been locked in a standoff with the FDA, which claims the MG is operating as a medical device without proper authorization. Whoop has continued to offer the feature, despite a warning from the federal agency.
While these newer smartwatches and fitness trackers don’t require the user to wear a blood pressure cuff every time they want a reading, the companies do ask consumers to periodically use the more traditional technique to help calibrate the estimates.
Withings’ latest scale takes a different approach to blood pressure management. The device looks for signs of hypertension, the company said, and notifies users that they’re at risk of high blood pressure, rather than issuing something that could be construed as a more definitive diagnosis. Withings said the Body Scan 2 measures more than 60 biomarkers, up from 40-plus in the first-generation Body Scan.
Discussions with the FDA about the hypertension risk detection tool are "going well,” said Antoine Joussain, director of product management for Withings devices. "We might not release it exactly when the product is ready,” he said in an interview, adding that the company is confident it will be able to roll out the feature "really, really close” to the hardware’s on-sale date.
The company, which released its first smart scale in 2009, has long since expanded into metrics besides weight, such as calculations for body, muscle and bone mass. More recent additions have attempted to help consumers assess their underlying health. The first version of the Body Scan, which was announced in early 2022, introduced detection for atrial fibrillation, a type of irregular heartbeat. But that product was slow to hit shelves in the US precisely because Withings was waiting for FDA clearance for the feature.
When asked if he expects a similar delay for the Body Scan 2’s hypertension risk detection feature, Joussain pointed to a more streamlined process, saying "the FDA has been changing a bit in the way we can clear such devices.”
"I’m not saying it’s easier, but at least now there is a path that we all better understand,” he said, referring to Withings and its peers operating in the US. Other companies have been "too aggressive” in their approach to dealing with the FDA, he added, without naming Whoop.
Joussain said he expected that the original Body Scan’s electrocardiogram feature, which is also present on the new model, will receive faster clearance this time around since the technology and implementation on the Body Scan 2 aren’t new.
Withings is once again an independent company after multiple ownership changes over the past decade. It spent two years under the ownership of Finland’s Nokia Oyj, which bought the company in 2016 only to sell it to co-founder Eric Carreel in 2018. – Bloomberg
