NEUCHÂTEL, Switzerland, June 12, 2024 /PRNewswire/ -- Aktiia, the Swiss startup revolutionizing Blood Pressure (BP) monitoring and management, announces it has received regulatory approval (CE mark) for its next-generation optical technology that does not require calibration with a traditional cuff.

瑞士NEUCH TEL，2024年6月12日/PRNewswire/-Aktia是瑞士一家革新血压（BP）监测和管理的初创公司，它宣布其下一代光学技术已获得监管部门的批准（CE标志），该技术不需要使用传统袖带进行校准。

The CE mark allows market access to potentially over 40 countries. The underlying groundbreaking calibration-free technology, known as CALFREE™, uses input from optical sensors commonly found in either smartwatches or the cameras of commercial smartphones. This is a crucial first step towards integrating Aktiia's CALFREE technology into various third-party devices..

CE标志允许潜在的40多个国家进入市场。底层突破性的无校准技术称为CALFREE™，它使用智能手表或商用智能手机摄像头中常见的光学传感器的输入。这是将Aktia的CALFREE技术集成到各种第三方设备中的关键的第一步。。

Since its inception in 2018, Aktiia has been an innovative pioneer of blood pressure technology, known for its scientific rigor, visionary team, and initial breakthrough product – the first continuous BP monitoring device worn on the wrist, which currently requires monthly calibration. Today's announcement represents a significant advancement in BP data collection and hypertension management, enabling the development of optical systems that do not require any calibration while meeting the stringent BP performance thresholds for regulatory approval..

自2018年成立以来，Aktia一直是血压技术的创新先驱，以其科学严谨、富有远见的团队和最初的突破性产品而闻名，这是第一款佩戴在手腕上的连续血压监测设备，目前需要每月校准。今天的宣布标志着BP数据收集和高血压管理取得了重大进展，使得不需要任何校准的光学系统的开发能够满足监管部门批准的严格BP性能阈值。。

The healthcare industry is already taking note: 'The ability to monitor blood pressure without using a cuff is a game-changer. This achievement has the potential to greatly improve hypertension care, from better patient motivation to more efficient medication regimens,' said Adrian James, former President of Omada Health..

医疗行业已经注意到：“不使用袖带监测血压的能力改变了游戏规则。Omada Health前总裁阿德里安·詹姆斯（AdrianJames）说，这一成就有可能极大地改善高血压护理，从更好的患者动机到更有效的药物治疗方案。。

Aktiia's blood pressure dataset is growing exponentially, with over 10 billion signals from more than 70,000 users worldwide, creating countless opportunities for discoveries that advance our collective understanding of blood pressure and provide predictive insights on a global scale. This extensive dataset has enabled Aktiia to create unprecedented Foundation Models of blood pressure, previously unattainable without the size and richness of this extensive dataset..

Aktia的血压数据集呈指数级增长，来自全球70000多名用户的信号超过100亿，为发现创造了无数机会，这些发现促进了我们对血压的集体理解，并在全球范围内提供了预测性见解。这个广泛的数据集使Aktia能够创建前所未有的血压基础模型，如果没有这个广泛数据集的大小和丰富性，以前是无法实现的。。

Transforming Wearables and Smartphones into Medical-Grade Devices

将可穿戴设备和智能手机转变为医疗级设备

Approval of the CALFREE technology sets the stage for Aktiia to transform BP monitoring and management by enabling the integration of a medical-grade blood pressure system into a wide range of consumer devices (smartwatches, smartbands, and smartphone cameras), dramatically changing the ease and convenience of collecting data on one of the most impactful vital signs – blood pressure..

CALFREE技术的批准为Aktia转变血压监测和管理奠定了基础，它将医疗级血压系统集成到各种消费设备（智能手表、智能波段和智能手机摄像头）中，极大地改变了收集最具影响力的生命体征之一——血压数据的便捷性。。

'This regulatory approval of Aktiia's CALFREE technology is the realization of a lifetime of work and a crucial step towards achieving our ultimate dream – to improve BP management and reduce the impact of hypertension on global health,' said Dr. Josep Sola, CTO and Co-founder of Aktiia.

Aktia首席技术官兼联合创始人约瑟夫·索拉（JosepSola）博士说：“Aktia的无钙技术获得监管部门的批准，是实现我们一生的工作，也是实现我们最终梦想的关键一步，即改善BP管理，减少高血压对全球健康的影响。”。

Addressing a Global Health Crisis

应对全球健康危机

Hypertension, often referred to as a 'silent killer,' is the leading cause of cardiovascular diseases worldwide. The World Health Organization (WHO) reports that the number of adults with hypertension has doubled from 650 million in 1990 to 1.3 billion in 2019, with projections reaching 1.5 billion by 2025.

高血压通常被称为“沉默杀手”，是全球心血管疾病的主要原因。世界卫生组织（WHO）报告称，患有高血压的成年人人数已从1990年的6.5亿增加到2019年的13亿，预计到2025年将达到15亿。

The current methods of blood pressure monitoring, still reliant on 19th Century technology,  involve cumbersome and often inaccurate cuff-based devices, and  are inadequate for the growing need for effective hypertension management in the modern age..

目前的血压监测方法仍然依赖于19世纪的技术，涉及笨重且通常不准确的基于袖带的设备，不足以满足现代对有效高血压管理日益增长的需求。。

Aktiia's CALFREE technology extends its position of offering the most accessible, comfortable, and convenient method for long-term blood pressure monitoring. Improved data collection is a cornerstone to significantly improving blood pressure management and helping reduce the economic and health burdens associated with hypertension..

Aktia的CALFREE技术扩展了其为长期血压监测提供最易获得、舒适和方便的方法的地位。改进的数据收集是显着改善血压管理并帮助减轻与高血压相关的经济和健康负担的基石。。

'Aktiia's innovative approach to data collection is transforming blood pressure management. By harnessing the power of our vast and rich dataset, predictive, precision BP care can be delivered on the scale required for impactful blood pressure management,' said Dr Jay Shah, CMO of Aktiia.

“Aktia的创新数据收集方法正在改变血压管理。Aktia首席营销官杰伊·沙阿（JayShah）博士说，通过利用我们庞大而丰富的数据集，可以按照有效血压管理所需的规模提供预测性、精确的血压护理。

About Aktiia

关于Aktia

Founded in Switzerland in May 2018, Aktiia was created out of a passion to develop the best products for diagnosing and treating hypertension. Founders Drs. Mattia Bertschi (CEO) and Josep Solà (CTO) spent 15 years at the prestigious Swiss research institute CSEM, deciphering the language of the heart to deepen our understanding of blood pressure.

Aktia于2018年5月在瑞士成立，致力于开发诊断和治疗高血压的最佳产品。创始人Mattia Bertschi博士（首席执行官）和Josep Solà（首席技术官）在著名的瑞士研究所CSEM工作了15年，破译了心脏的语言，加深了我们对血压的理解。

Today, Aktiia's diverse team of over 50 extraordinary individuals is transforming years of innovative research into a global healthcare solution, offering the most complete and intuitive blood pressure monitoring and management tools on the market..

如今，Aktia由50多名杰出人士组成的多元化团队正在将多年的创新研究转变为全球医疗保健解决方案，提供市场上最完整和直观的血压监测和管理工具。。

The company's first product, the Aktiia G1, gained CE-marking in December 2020, offering continuous blood pressure monitoring with monthly calibrations. The newly CALFREE technology represents the next generation, providing on-demand blood pressure readings without the need for calibration. This approval marks the first time a device of this kind has been recognized by regulatory authorities..

该公司的第一款产品Aktia G1于2020年12月获得CE标志，提供每月校准的连续血压监测。最新的无钙技术代表了下一代技术，可提供按需血压读数，无需校准。该批准标志着此类设备首次获得监管机构的认可。。