Aktiia has received FDA clearance for over-the-counter (OTC) use of its cuffless blood pressure monitoring technology, which the company is calling a first in the U.S. Marketed under the brand Hilo, the product will be made available to U.S. consumers in 2026.
This regulatory clearance follows an oversubscribed Series B round of more than $42 million co-led earlier this year by Earlybird Venture Capital and Wellington Partners.
Aktiia said it has used billions of optical signals and hundreds of millions of blood pressure readings collected from more than 130,000 users to develop a scalable solution to address health challenges.
Although the device does not require a cuff to be worn while it use, it still requires calibration using a cuff, which it provides with the purchase.
