Aktiia's cuffless blood-pressure bet wins FDA's first OTC clearance

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.

That consumers would monitor blood pressure with a cuffless optical wearable if regulators let them buy it without a prescription, making an OTC label the moat.

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.

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.

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.

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.

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.

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.

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.