Aktiia的无袖带血压计获FDA首个非处方许可

做的是什么生意

Aktiia, the Neuchâtel company behind the Hilo brand, sells a wristband that estimates blood pressure continuously from optical signals after monthly calibration against a standard cuff, tracking readings during the day and overnight through a companion app.

启动资金：Aktiia raised an oversubscribed $42M Series B in May 2025 co-led by Earlybird Health and Wellington Partners, bringing total funding above $100M; earlier rounds included CHF 27M in 2024, a $17.5M Series A in 2021 and $6.1M in 2020.

起因

The company spun out of Swiss research institute CSEM, where the underlying optical blood-pressure research had run for twenty years, and was founded in 2018 with a direct bet: hypertension affects over a billion people and remains the leading risk factor for cardiovascular disease, yet cuff measurements capture only isolated moments, so a wearable that tracked blood pressure continuously could be a mass-market product instead of a clinic tool.

经过

Aktiia first earned a CE mark in Europe and sold more than 120,000 devices across markets including Canada, Australia and Saudi Arabia, rebranding to Hilo in May 2025 alongside a $42M Series B co-led by Earlybird Health and Wellington Partners. A study with Mass General Brigham on patients with uncontrolled hypertension found 91% preferred the Hilo monitor to daily cuff measurements. The regulatory payoff came on 2025-07-07, when the FDA granted 510(k) clearance for over-the-counter use of the G0 system — the first time it had cleared any cuffless blood-pressure monitor for sale without a prescription.

结果

The seven-year bet cleared the gate: Aktiia holds the world's first FDA-cleared, OTC, cuffless blood-pressure solution and announced the product would reach US consumers in 2026, with the Hilo brand positioned to define the category in its largest untapped market.

可借鉴之处

消费医疗设备的成败取决于监管机构对其品类的定义：Aktiia七年1亿美元的赌注，实际上是赌在赢得无竞争对手持有的非处方标签上。