Samsung’s long-gestating effort to bring blood pressure monitoring to its Galaxy Watch wearables took a step forward today, as the company announced it has finally received clearance to make its blood pressure app available in one country — the first positive sign in a regulatory process that’s been underway for more than a year. But the potentially lifesaving feature still has some major hurdles to overcome before it sees widespread consumer use.
On a positive note, Samsung’s Health Monitor app has been cleared by the South Korean government under “software as a medical device” guidelines, which enable existing devices to add new health features through apps. This will enable South Korean users of the Galaxy Watch Active2 — and “upcoming Galaxy Watch devices” — to do partially cuffless blood pressure monitoring, at least in that country. Regulatory approval is required on a country-by-country basis for new medical features.
Blood pressure monitoring is critical in detecting hypertension, a potentially serious indicator of heart distress, and hypertensive crises, which could indicate that a stroke, heart attack, or other major organ failure is either imminent or in process. Since most people don’t wear blood pressure cuffs on their arms all day, and pneumatic cuffs noisily inflate on the bicep or wrist to take measurements, offering this functionality in a comfortable and persistently used wearable could easily save lives.
But the challenge for Samsung and others has been to make a wearable’s readings medically accurate within a much smaller, non-pneumatic form factor, and Samsung’s Health Monitor app only gets part of the way there. Users must calibrate the app using a traditional blood pressure cuff every four weeks at a minimum, enabling the watch’s pulse wave analysis system to refine its findings. Each calibration requires taking three separate cuff readings, and it’s likely that users will do so at home, which will require buying a cuff at additional ($30-$50) expense.
In other words, the Galaxy Watch won’t be able to entirely replace the need for a cuff, but it will fill in the gaps between conventional readings. Users will be asked to hit a “measure” button in the app to check their blood pressure, then wait roughly two minutes while sitting still without talking. That’s longer but nearly as simple as Apple’s ECG app for Apple Watches — a similar breakthrough that only years ago was nearly impossible to imagine on such small wearables.
Now the challenge is to actually get Health Monitor into customers’ hands. Despite receiving South Korean approval, Samsung is only planning to start offering the app in the third quarter of 2020, and hasn’t yet indicated other countries where the functionality will be available. The company began testing a similar app, My BP Lab, back in February 2019 with the University of California, San Francisco, enabling some users in Australia, Canada, Germany, Singapore, the U.K., and the U.S. to trial blood pressure monitoring in Galaxy Watch Active and Active2 watches. It’s unclear at this point whether regulators in those countries will be on board for Health Monitor’s launch later this year.