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可穿戴医疗设备行业把握:政策扶持与消费升级共振,健康监测应用加速落地:(2025.10.27—2025.10.31)
Huafu Securities· 2025-11-03 07:39
Group 1 - The wearable medical devices industry is experiencing rapid growth driven by technological advancements, product innovation, remote monitoring, home healthcare, and increased health awareness, with the global market expected to reach USD 42.74 billion in 2024 and grow to USD 168.29 billion by 2030, representing a compound annual growth rate (CAGR) of 25.53% [2][8][10] - In China, the wearable device market is the largest globally, with a year-on-year sales increase of 41.0% in January 2025, driven by the "National Subsidy" policy, which significantly boosted sales of smartwatches and wristbands by 33.7% and 68.0% respectively [9][10] - The market is benefiting from enhanced product cost-performance due to subsidies and promotions, leading to increased demand for both replacement and new users, particularly in the price segments of RMB 500-2000, which saw sales growth rates of 83.1%, 112.3%, and 77.0% respectively [9][10] Group 2 - The wearable medical devices encompass various forms such as headbands, necklaces, glasses, smartwatches, and wristbands, which monitor parameters like heart rate, sleep, and blood pressure, utilizing optical sensors for blood pressure and blood component monitoring [7][8] - Despite the rapid development, the industry faces challenges including data security, lack of unified standards, and issues with monitoring data accuracy and medical device certification [10] - The industry is entering a phase of accelerated development characterized by policy support and consumption upgrades, positioning wearable medical devices as a crucial component in health monitoring and intervention treatment [2][10]
获批FDA!全球首款无袖带血压监测系统
思宇MedTech· 2025-07-09 10:36
Core Viewpoint - Aktiia's G0 system represents a significant shift in blood pressure management from traditional cuff-based methods to a non-invasive, continuous, and wearable technology, receiving FDA approval as the first over-the-counter (OTC) blood pressure monitoring device [1][3][10] Group 1: Product Features and Innovations - The G0 system utilizes photoplethysmography (PPG) technology and the proprietary CALFREE algorithm to estimate systolic and diastolic blood pressure without the need for traditional cuff calibration [3][4] - It offers a lightweight design (approximately 22 grams) and automatic measurements every two hours, resulting in about 150 measurements per week, significantly higher than traditional devices [4][10] - The device provides real-time data visualization through the Hilo App, allowing users to track their blood pressure trends and share data with healthcare providers [4][10] Group 2: Clinical Validation and Data Support - Aktiia submitted key clinical trial data to the FDA, involving 140 patients, which demonstrated that the G0 system's measurements were within acceptable ranges compared to the gold standard of blood pressure measurement [6][7] - The results met ANSI/AAMI/ISO 81060-2:2013 standards, with mean differences for systolic and diastolic pressures being 1.3 ± 7.11 mmHg and -0.2 ± 5.46 mmHg, respectively [9][7] Group 3: Market Strategy and Financials - Aktiia plans to launch the G0 system in the U.S. market in 2026, targeting retail pharmacies, e-commerce, and medical channels, with an expected price of around $300 [1][10] - The company raised over $42 million in a Series B funding round to accelerate U.S. market entry and further optimize its algorithms [10] - Since its inception in 2018, Aktiia has accumulated over 130,000 users in Europe and collected more than 1 billion blood pressure measurements, establishing a robust database for algorithm improvement [7][10] Group 4: Competitive Landscape - While Aktiia G0 is the first OTC device approved by the FDA, it faces competition from other wearable blood pressure monitoring devices like Omron HeartGuide and LiveMetric, which have different measurement methods and user experiences [11][13][15] - Aktiia's advantages include its OTC status, continuous monitoring capability, and user engagement, but it also faces challenges such as non-waterproof design and the need for market education [11][17] Group 5: Company Overview - Founded in 2018 and headquartered in Neuchâtel, Switzerland, Aktiia focuses on developing non-invasive, continuous blood pressure monitoring technologies [18] - The company's mission is to provide daily, accurate blood pressure management solutions for hypertension patients through lightweight wearable devices and AI algorithms [18]
融资超3亿!AI血压管理公司完成B轮
思宇MedTech· 2025-05-02 13:29
报名:首届全球心血管大会 | 最新议程 合作伙伴征集:2025全球手术机器人大会 传统血压计的束缚是否无法避免? 瑞士公司 Aktiia 给出的答案是否定的。这家专注于无袖带连续血压监测的公司,2025年5月2日宣布,完成了 4 200万美元(3.05 亿人民币)B轮融资 ,并正式更名为 Hilo ,计划将其 AI 驱动的手腕可穿戴设备推向全球市场。 Hilo采用独特的光学监测与人工智能算法组合,提出一种 无需袖带、连续、便捷的血压管理路径 ,正在逐步改变临床医生和高血压患者的监测方式。 # 核心产品机制:无创、连续、可穿戴 Hilo 的产品是一款基于光电容积描记术(PPG)技术的手环设备,可 全天候、非侵入式地测量血压和心率 ,用户仅需佩戴在手腕处即可。 技术原理 使用流程 PPG传感器 :通过检测小血管中血容量变化获取原始信号; AI算法建模 :使用数十亿个光学信号和数亿次历史测量数据训练出的模型,用于实时估算收缩压与舒张压; 自动测量机制 :设备每小时自动测量一次血压,包括夜间,在用户静止约30秒时启动测量。 首次使用需校准 :通过标准袖带血压计进行一次初始校准; 每月一次再校准 :为保持精度,用户需每 ...