Latest news with #Aktiia
Cision Canada
7 days ago
- Business
- Cision Canada
Aktiia's Hilo Band Becomes First Cuffless Blood Pressure Monitor Cleared by FDA for Over-the-Counter Use
The FDA-cleared G0 Blood Pressure Monitoring System - marketed as Hilo Band - will bring cuffless blood pressure monitoring to U.S. consumers NEUCHTEL, Switzerland, July 9, 2025 /CNW/ -- Aktiia, a pioneer in optical blood pressure monitoring, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter (OTC) use of its cuffless blood pressure monitoring technology. This clearance, granted for Aktiia's G0 Blood Pressure Monitoring System, marks the first time the FDA has cleared a cuffless blood pressure monitor indicated for over-the-counter (OTC) use in the United States. While Aktiia's innovative blood pressure monitoring products are already CE marked and available in Europe under the brand Hilo, the product will be made available to US consumers in 2026. Trusted by over 130,000 users globally, the Hilo Band has demonstrated the impact of Aktiia's technology in real-world settings. With this FDA clearance, consumers in the U.S. will soon have access to the same clinically validated innovation behind the Hilo Band and app. With no medical prescription required, it is now the first cuffless blood pressure monitor authorized for over-the-counter use in the United States. The milestone sets a new global benchmark for how blood pressure can be effortlessly monitored through wearable, user-friendly technology. With this FDA clearance, Aktiia is now positioned to establish Hilo as the category-defining wearable for cuffless blood pressure monitoring in the U.S. and beyond. " This is not just a regulatory win: it's the start of a paradigm shift in hypertension management," said Josep Sola, Co-Founder and CTO of Aktiia. " With FDA's OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions." " This milestone is the result of more than seven years of relentless scientific, clinical, and engineering effort," said Mattia Bertschi, Co-Founder of Aktiia. " What began as a research vision in the Swiss Research Institute CSEM twenty years ago has now become the world's first cuffless, FDA-cleared, over-the-counter solution for blood pressure – and we're just getting started." This regulatory clearance follows an oversubscribed Series B round of over $42 million USD co-led earlier this year by Earlybird Venture Capital and Wellington Partners. "Aktiia's FDA clearance represents a breakthrough moment for medical-grade wearables," said Dr. Christoph Massner, Principal at Earlybird and Board Director of Aktiia. "We backed the team because they combined bold vision with scientific rigor; and today they've delivered what no one else could. The Hilo Band is poised to lead a global transformation in how we understand and manage cardiovascular health at scale." The Hilo Band is not just another wearable: it is the first of its kind blood pressure companion, marking a breakthrough moment for cardiovascular health, much like the iPhone did for mobile technology. Due to its sleek, lightweight and comfortable form factor, the Hilo Band ushers in a new class of medical wearables that empower individuals to monitor their blood pressure anytime, anywhere. Achieving this milestone reinforces Aktiia's leadership in cuffless, consumer-ready blood pressure monitoring, redefining what's possible in everyday cardiovascular care. About Aktiia Founded in 2018, Aktiia is transforming the way blood pressure is measured and managed. By harnessing one of the world's largest datasets of optical signals, its cuffless monitoring product (commercially known as the Hilo Band) provides clinically meaningful insights to both individuals and healthcare professionals, making blood pressure tracking more accessible and effortless than ever before. With billions of optical signals and hundreds of millions of blood pressure readings collected from over 130,000 users, Aktiia has developed a robust and scalable solution to address one of the world's most pressing health challenges. Hypertension affects more than 1.3 billion people globally and remains the leading risk factor for cardiovascular disease; yet most cases remain undiagnosed or poorly managed. By enabling seamless and user-friendly monitoring at home, Aktiia is poised to transform how hypertension is detected and managed worldwide. Backed by a multidisciplinary team with deep expertise in biomedical signal processing and machine learning, Aktiia's innovation is supported by more than 120 peer-reviewed publications and over 35 patents. Headquartered in Switzerland, the company is expanding internationally to make accessible, cuffless blood pressure monitoring the new standard of care in home hypertension management. Note: The Hilo Band requires calibration using a cuff, which is provided with the purchase.
Cision Canada
02-05-2025
- Business
- Cision Canada
Aktiia secures $42 million in Series B funding round and rebrands to Hilo
With fresh funding round, the health tech pioneer continues to work toward managing the world's blood pressure. LONDON, May 2, 2025 /CNW/ -- Aktiia, a blood pressure intelligence platform, announces an oversubscribed $42 million (over CHF 34 million) Series B funding round, co-led by Earlybird Health and Wellington Partners, with new investors Kfund and naturalX Health Ventures, and participation from existing investors redalpine, Khosla Ventures, Molten Ventures, Translink Capital and Verve Ventures. The investment, which has brought the total financing to date above $100 million, will accelerate the company's mission to manage the world's blood pressure. The latest investment builds on a period of significant momentum for the company during which it has achieved several major milestones, including securing CE marking for its innovative mobile phone camera blood pressure monitoring technology, securing regulatory approvals in Canada, Australia and Saudi Arabia, achieving 76% compounded annual revenue growth, and completing a pivotal clinical trial ahead of its U.S. FDA application submission. This Series B funding will fuel continued product innovation, expansion into new markets and the build out of its blood pressure intelligence platform to support enterprise use cases. Alongside this funding, Aktiia is introducing its new brand identity: Hilo - a rebrand which reflects the company's global ambition to make cuffless, clinically validated blood pressure monitoring universally accessible and effortless. The transition to Hilo marks an important milestone in the company's journey, aligning with its vision of healthier blood pressure for all, while continuing to deliver the trusted technology and reports that have been central to its platform. With more than 120,000 devices sold, Hilo has already established itself as a stand-out in the health tech space. The company has developed a foundation Machine Learning model specifically designed for blood pressure. The model has been trained on tens of billions of optical signals from real-world users and further refined with hundreds of millions of calibration points, strengthening its position as the leader in the emerging cuffless blood pressure monitoring (CBPM) category. Raghav "Rags" Gupta, CEO of Hilo, commented: "This funding round is a testament to the confidence our investors have in Hilo's groundbreaking technology and our mission to manage the world's blood pressure via more frequent, convenient and accurate measurements. With billions worldwide suffering from hypertension, only 20% of whom are in control of their blood pressure, the need for innovative, accessible blood pressure monitoring solutions has never been greater. Our rebrand to Hilo represents more than just a name change, it's a commitment to empowering users around the world with smarter tools to optimise their health. We are grateful to early Aktiia customers for their support and to our investors, new and existing, for their faith." Christoph Massner, Principal at Earlybird Health, who will join Hilo's Board of Directors, commented: "Hilo stands at the intersection of medical-grade precision and consumer-centric accessibility. By building on a validated medical device platform and an intuitive, user-friendly design, they bridge the gap between clinical reliability and everyday usability. It's a rare combination that empowers users to take meaningful control of their health with minimal effort. This is especially critical given the enormous medical need: uncontrolled high blood pressure remains one of the leading risk factors for death worldwide." Johannes Fischer, Managing Partner at Wellington Partners, commented: "We are excited to co-lead this financing and to be backing Hilo's innovative technology, which provides groundbreaking advancements to the billions of people with elevated blood pressure today. We believe that real-time and continuous access to blood pressure information will change the way we think about the monitoring and management of one of the most common risk factors to human health." About Hilo Aktiia, now trading under Hilo, was established in 2018 to transform how blood pressure is measured and therefore managed. By integrating advanced AI algorithms with extensive datasets, Hilo's cuffless blood pressure monitoring (CBPM) products offer convenient, valuable reports to give both individuals and healthcare professionals a useful picture of their blood pressure. The company's foundation model for blood pressure has been trained on billions of optical signals and hundreds of millions of readings across more than 120,000 users, underscoring its leadership in the CPBM category. The company's multidisciplinary team, composed of experts with extensive experience in biomedical signal processing, has contributed to over 120 peer-reviewed publications and holds more than 35 patents. Headquartered in Switzerland, Hilo continues to expand its global presence, transforming how blood pressure is understood and managed.
