Aktiia

Aktiia SA, founded in May 2018 and headquartered in Neuchâtel, Switzerland, represents 20+ years of blood pressure research commercialization. Co-founders Dr. Mattia Bertschi (Board Chair) and Dr. Josep Solà (CTO) spent 15 years at the prestigious Swiss research institute CSEM developing optical blood pressure monitoring (OBPM) technology before spinning out Aktiia.

The company achieved a historic milestone in 2024 when the FDA cleared their Hilo wristband as the first over-the-counter cuffless blood pressure monitor, with U.S. launch planned for 2026. CEO Raghav (Rags) Gupta leads a team that has raised $30 million in Series A funding from Molten Ventures, Khosla Ventures, and Verve Ventures, among others.

Aktiia holds ISO 13485:2016 certification and operates additional offices in Australia (Randwick NSW) and Netherlands (Waalwijk). With over 120,000 units sold across Canada, Australia, Saudi Arabia, and Europe, the company has deployed its technology across diverse real-world populations, training AI models on 11 billion data points of blood pressure measurements.

Aktiia's breakthrough centers on calibration-free optical blood pressure monitoring (OBPM), eliminating the monthly cuff calibration required by earlier cuff-less devices. The system combines wrist-based photoplethysmography (PPG) with proprietary AI algorithms trained on unprecedented scale:

Optical Pulse Wave Analysis: PPG sensors embedded in the wrist bracelet shine light through skin to measure arterial pulsations. Unlike simple heart rate tracking, Aktiia's algorithms analyze pulse wave morphology—the detailed shape of each arterial pressure waveform—to extract blood pressure values. Changes in pulse rise time, amplitude, and dicrotic notch position correlate with systolic and diastolic pressure variations.

AI Training at Scale: The company applied generative AI to 11 billion annotated data points from their deployed user base, creating subject-independent models that eliminate personalized calibration. In March 2024, Aktiia released CALFREE technology, achieving CE mark approval for calibration-free BP measurement—a first in wearable BP monitoring. The FDA-cleared Hilo band extends this capability to over-the-counter use.

Continuous Automated Monitoring: The bracelet automatically captures blood pressure measurements up to 50+ times daily during rest periods, building comprehensive ambulatory BP profiles without user intervention. The companion smartphone app displays trends, generates reports, and flags hypertensive patterns. Accuracy has been demonstrated across diverse skin tones in clinical validation studies.

Product Evolution: The original Aktiia Bracelet (G1) received CE mark in December 2020 with monthly calibration requirement. The next-generation platform achieved calibration-free operation, culminating in the Hilo wristband's FDA OTC clearance in 2024—the first cuff-less device approved for direct consumer purchase without prescription.

FDA Over-the-Counter Clearance (2024): The Hilo wristband became the first cuffless blood pressure monitor cleared by FDA for OTC use, representing "the start of a paradigm shift" according to cardiovascular medicine experts. The device is expected to reach the U.S. market in 2026, following successful launches in Canada, Australia, and Saudi Arabia.

CE Mark (Class IIa Medical Device): Aktiia holds CE marking under EU Medical Device Regulation 2017/745 for both the original G1 bracelet (December 2020) and the calibration-free CALFREE technology (June 2024). The devices meet European standards for accuracy, safety, and clinical performance.

ISO81060-2 Extended Protocol Validation: A peer-reviewed study (published in Blood Pressure Monitoring, NCT04027777) validated the Aktiia Bracelet over 1 month using an extended ISO81060-2 protocol adapted for cuffless wrist devices. Results showed the bracelet satisfied validation criteria 1 and 2 in sitting position, with accuracy maintained throughout the 1-month period after initialization.

24-Hour Ambulatory Comparison: Published research in Hypertension Research (2023) demonstrated that Aktiia's cuffless monitor yielded equivalent daytime blood pressure measurements compared to traditional 24-hour ambulatory BP monitors. The study validated the device's utility for continuous monitoring in real-world conditions.

Multi-Position Validation: A Scientific Reports study (2021) validated the optical Aktiia bracelet's accuracy in different body positions, demonstrating persistent BP monitoring capability during daily activities. The validation encompassed sitting, standing, and supine positions across diverse patient populations.

Five Clinical Studies: Aktiia completed five clinical studies during device development and validation phases, systematically addressing accuracy, reproducibility, and real-world performance. These studies established the evidence base for regulatory approvals across multiple markets.

Aktiia occupies a unique position as the only FDA-cleared over-the-counter cuffless blood pressure monitor, bridging the gap between consumer fitness wearables and clinical-grade medical devices. The FDA OTC clearance enables direct consumer purchase without prescription, dramatically expanding addressable market compared to prescription-only alternatives.

Calibration-Free Differentiation: The CALFREE technology eliminates the monthly cuff calibration burden plaguing earlier cuffless devices (Omron HeartGuide, Samsung Galaxy Watch), removing a major adoption barrier. Competitors requiring periodic calibration face user compliance challenges that degrade accuracy over time. Aktiia's subject-independent AI models trained on 11 billion data points solve this through population-scale learning rather than individual calibration.

Regulatory Credibility: With FDA OTC clearance, CE mark (Class IIa), Health Canada approval, and MDSAP certification, Aktiia has navigated the most stringent regulatory pathways. This contrasts sharply with consumer wearables making wellness claims without medical device approval. The regulatory portfolio enables clinical adoption, insurance reimbursement pathways, and professional medical market penetration beyond direct-to-consumer sales.

Clinical Validation Evidence: Five published clinical studies, peer-reviewed validation against ISO81060-2 protocols, and equivalence to 24-hour ambulatory monitoring establish credibility with healthcare providers. This evidence base positions Aktiia for integration into hypertension management protocols, remote patient monitoring programs, and clinical research applications.

Market Traction: Over 120,000 units sold across Canada, Australia, Saudi Arabia, and Europe demonstrate commercial viability and real-world acceptance. The $30 million Series A from Khosla Ventures and other tier-1 investors validates the business model and provides runway for U.S. market entry (2026) and continued R&D. The rebrand to "Hilo" for consumer markets signals strategic positioning for mass-market appeal.

Competitive Challenges: Apple, Samsung, and Fitbit possess distribution scale, brand recognition, and ecosystem integration that dwarf Aktiia's reach. If these incumbents achieve regulatory clearance for blood pressure monitoring, Aktiia faces existential competitive pressure. Success depends on maintaining technological lead (calibration-free accuracy), building clinical adoption, and establishing first-mover advantages in regulated markets before tech giants enter.