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Empatica 推出获 FDA 许可的帕金森居家监测设备 WellPD

Empatica launches WellPD, an FDA-cleared Parkinson's monitoring device for home use

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Empatica 推出面向帕金森患者的可穿戴设备及配套应用 WellPD,已获 FDA 许可和 CE 认证,可在居家环境监测震颤、运动障碍和运动迟缓等运动症状以及睡眠与活动情况。配套应用将测量结果汇总为每日摘要,并结合用药记录帮助患者识别症状波动与药效变化,便于与照护团队沟通。该产品目前在美国、加拿大、英国、澳大利亚、新西兰及部分欧洲经济区国家开放订购。

正文 · 原文

, /PRNewswire/ -- Empatica, a leader in digital biomarker development and clinical-grade wearable technology, today announced WellPD, an FDA-cleared and CE-marked wearable device and companion app for people with Parkinson's to monitor their symptoms at home.

WellPD, Empatica’s wearable device and companion app

WellPD, Empatica’s wearable device and companion app

WellPD's wrist-worn device tracks motor symptoms, including tremor, dyskinesia, and bradykinesia, as well as sleep and activity. The companion app brings these measurements together with daily summaries, helping people understand how their symptoms fluctuate, recognize changes around medication doses, and discuss these patterns with their care teams.

"Empatica was founded on the belief that technology should be friendly, caring, and more human," said Matteo Lai, CEO and co-founder of Empatica. "With WellPD, we're bringing years of work in wearable technology and Parkinson's research into a comfortable device that can be worn at home, giving people with Parkinson's and their families access to daily health information they can understand and share with their care teams."

A clearer picture of health between appointments

Parkinson's symptoms can vary from one hour to the next, including as medication takes effect or wears off. During an appointment, recalling when those changes happened, how long they lasted, and how they affected daily life can be challenging.

WellPD records movement and other body signals, which clinically validated algorithms translate into measurements of motor symptoms, sleep, and activity. Alongside medication logs, these measurements can help people recognize patterns, such as disrupted sleep or changes in movement around medication doses.

Daily summaries help people follow these changes without relying on memory or recording details in a diary. For family members and caregivers, the information can offer another way to understand and support their loved one. For clinicians, it can provide additional context about symptoms between visits.

"Parkinson's disease is one of the most common and treatable neurological disorders, yet its complexity often leads to suboptimal care" said Dr. Alessandro Di Rocco, neurologist and system director for Parkinson's and Movement Disorders at Northwell Health. "Digital wearables can transform a complex mix of symptoms into clear, accurate, and actionable data. When evaluating patients, clinicians need to understand their daily life at home—how they sleep, respond to treatment, and manage symptoms. Objective insights from wearable technology provide this vital context, complementing patient feedback to enable more informed care and tailored treatments.

Built on established Parkinson's expertise

WellPD combines Empatica's experience in medical devices with the Parkinson's expertise of PKG Health, which Empatica acquired in 2025. Empatica's PKG algorithms are supported by more than 70 peer-reviewed publications and used in more than 150 hospitals and clinical sites worldwide. The technology also supports Parkinson's research by pharmaceutical companies, universities, and teaching hospitals, including studies of disease progression, treatment response, and digital measures in clinical trials.

Availability

WellPD is now available to order in the United States, Canada, the United Kingdom, Australia, New Zealand, and the following countries in the European Economic Area: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Malta, the Netherlands, Norway, Spain, and Sweden.

To learn more, visit empatica.com/wellpd

WellPD is covered by Empatica Health Monitoring Platform for PD Monitoring - 510(k)  Clearance - K260374

About Empatica

Empatica is a leader in continuous remote health monitoring, using medical wearables and connected technology to turn health data into meaningful insights. Its FDA-cleared and CE-marked products support clinical trials, research, and care across a range of neurological and health conditions, including epilepsy and Parkinson's.

Media Contact

Madison Hamilton, [email protected]

SOURCE Empatica, Inc.

来源:PR Newswire Health · prnewswire.com

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