The archive · Health & Care · Strategic decision · 2018–2025
Aktiia's cuffless blood-pressure bet wins FDA's first OTC clearance
Seven years and $100M+ later, Aktiia won FDA's first OTC clearance for a cuffless blood-pressure monitor, opening the US market.
Aktiia (Hilo)
What the business is
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.
Starting capital：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.
How it started
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.
What happened
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.
How it ended up
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.
Background
Aktiia is a Swiss health-technology company, founded in 2018 out of research institute CSEM, that sells a wristband estimating blood pressure continuously from optical pulse-wave signals after monthly calibration against a standard cuff. Its bet was that hypertension — which the company says affects more than 1.3 billion people worldwide and is the leading risk factor for cardiovascular disease — could be managed better with continuous readings than with the isolated moments captured by an inflatable cuff.
The company first proved the technology in Europe, earning a CE mark and selling more than 120,000 devices, and in May 2025 rebranded to Hilo while closing an oversubscribed $42M Series B co-led by Earlybird Health and Wellington Partners that brought total funding above $100M. A study with Mass General Brigham found that 91% of patients with uncontrolled hypertension preferred the Hilo monitor to daily cuff measurements.
The payoff came on 2025-07-07, when the FDA granted 510(k) clearance for over-the-counter use of Aktiia's G0 system — the first time any cuffless blood-pressure monitor was cleared for US sale without a prescription. With that OTC label, Aktiia announced the product would reach US consumers in 2026, entering its largest market holding a category-defining regulatory position that no rival had.
What has to be true
- Continuous readings beat spot cuff checks clinically, but selling them in the US required a regulatory label — so the OTC clearance became the whole point of the company.
- Monthly cuff calibration let a wristband stay accurate across skin tones and positions, giving regulators the evidence to treat it as a consumer product rather than a prescription device.
- Europe provided the proving ground: CE-marked sales of more than 120,000 devices generated real-world data and revenue while the longer US regulatory path ran in parallel.
- Being first mattered more than being fastest to market: the FDA's first OTC clearance in the category let Aktiia define what consumers and partners expect from cuffless monitoring.
What can be applied
A consumer medical device lives or dies on the regulator's definition of its category: Aktiia's seven-year, $100M bet was really a bet on earning an OTC label no competitor held.
Aftermath
As of 2025-07-09 Aktiia was selling its CE-marked Hilo band in Europe and other cleared markets, with more than 120,000 devices sold and total funding above $100M, preparing the US launch that the FDA's July 2025 OTC clearance unlocked for 2026. Co-founder Josep Sola called the decision the start of a shift in hypertension management, breaking down barriers that had kept cuffless monitoring out of consumers' hands; co-founder Mattia Bertschi pointed to more than seven years of work since the research began at CSEM two decades earlier.
Sources
- FDA clears over-the-counter, cuffless blood pressure monitor with the Hilo bracelet
- Hilo by Aktiia Received FDA 510(k) Clearance for its Blood Pressure Monitor Wristband
- FDA Clears Hilo Band: First Cuffless BP Monitor for OTC Use
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