A cuffless blood pressure band was cleared for sale without a prescription
In July 2025 the FDA cleared Aktiia's wrist-worn Hilo band, days before warning Whoop over a similar feature it had not reviewed.
Kivorent News desk, published , 1 min read
$42Mraised by Aktiia two months before clearance
This is a look back at an event from . We wrote it on November 11, 2026, from the sources listed at the end.
The Food and Drug Administration cleared a wrist-worn blood pressure monitor for sale without a prescription, the Swiss company Aktiia announced on July 8, 2025. The device is sold in Europe as the Hilo band.
How it works
An optical sensor on the wrist records the shape of each pulse. Software estimates blood pressure from that signal. It takes readings through the day, but only while the wearer is at rest, HLTH reported.
Aktiia had raised $42 million two months earlier and said it expected to sell the device in the United States in 2026.
Why it mattered
Six days later the FDA warned Whoop for offering blood pressure estimates without clearance. The two events showed the same rule from both sides. A wearable could estimate blood pressure in 2025, as long as it went through review first.
This article is general information about how technology works. It is not medical advice. Talk to a clinician about your own health.
Sources
- Aktiia gets FDA clearance for OTC cuffless blood pressure monitor, HLTH, July 8, 2025
FDA and health regulationHeart health techWearables
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