FDA approves Orthofix’s mobile app for bone growth stimulators

FDA 批准 Orthofix 用于骨生长刺激器的移动应用程序

2020-02-14 05:40:14 Mass Device


Orthofix Medical  announced today that it won FDA approval for its STIM onTrack mobile app version 2.1 for use with its bone growth stimulators. STIM onTrack is designed to work with Orthofix’s bone growth therapy devices as an accessory to help users adhere to prescriptions and improve clinical out comes. It is supposed to augment treatment with Orthofix’s CervicalStim, SpinalStim and PhysioStim bone growth stimulators. The latest version (2.1) of the app, which was initially released in 2017, hosts patient-reported outcome measure (PROM) questionnaires to enable users to remotely share the status of their quality of life and well-being with their physician, according to a news release. The app also offers daily treatment reminders and a device usage calendar to allow physicians to remotely view patient data to monitor their treatment. Lewisville, Texas-based Orthofix offers the app for free on iOS and Android device platforms. “We are proud to be the first in the bone growth stimulation market to be able to deliver tools to support physician remote patient monitoring endeavors to aid in a joint vision of improving patient outcomes,” Orthofix global president Kevin Kenny said in the news release. “We know that patients who take an active role in their follow-up care have an overall better recovery experience and outcomes,” added Yale University School of Medicine associate professor of orthopedics and rehabilitation Dr. Peter Whang. “The STIM onTrack mobile app version 2.1 is very beneficial for tracking adherence to their treatment plan, and the addition of the PROM questionnaire feature provides us with even more insights on how the patient is responding in their home setting, not just when they visit our office.”
Orthofix 医疗公司今天宣布,其 STIM 在 Track 移动应用程序版本2.1中获得 FDA 批准,用于骨生长刺激器。 STIMonTrack 的设计是将 Orthofix 的骨骼生长治疗设备作为辅助设备,帮助用户坚持处方和改善临床结果。它应该通过矫形外科的颈椎刺激器、脊柱刺激器和生理刺骨生长刺激器来加强治疗。 这款应用的最新版本(2.1)最初于2017年发布,它承载着患者报告的结果测量( PROM )问卷,使用户能够与医生远程分享他们的生活质量和幸福状况。 该应用程序还提供每日治疗提醒和设备使用日历,允许医生远程查看患者数据以监控他们的治疗。位于得克萨斯州路易斯维尔的 Orthofix 提供了应用程序免费在 iOS 和 Android 设备平台。 Orthofix 全球总裁凯文•肯尼( Kevin Kenny )在新闻稿中表示:“我们很自豪能够成为骨生长刺激市场的第一个能够提供工具,支持医生远程患者监测工作,帮助实现改善患者预后的共同愿景。” “我们知道,在后续护理中发挥积极作用的患者总体上有更好的康复经验和结果,”耶鲁大学医学院骨科和康复副教授 Peter Whang 博士说。“ STIM onTrack 移动应用程序版本2.1非常有利于跟踪患者对治疗计划的遵守情况, PROM 问卷功能的增加为我们提供了更多关于患者在家庭环境中如何反应的信息,而不仅仅是在他们访问我们的办公室时。”