• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    MPO's 2023 Medical Device Industry Year in Review

    The Beat Goes On in the Cardiovascular Device Market

    Medical Manufacturers Gain Support from 3D Printing

    The Intelligent Tools Medical Device Manufacturers Already Own

    MPO's 2023 Medtech Supply Chain Survey
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    ResMed Scores Legal Wins in Patent Spat with NYU

    NeuroOne Receives FDA Clearance for Ablation System

    AdvaMed Names GE HealthCare Leader Peter J. Arduini as Chairman

    Hologic Promotes Essex D. Mitchell to COO

    Medtronic, Cosmo Pharmaceuticals Fortify AI-Driven Endoscopy Partnership
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medical Device Industry Year in Review

    The Beat Goes On in the Cardiovascular Device Market

    Medical Manufacturers Gain Support from 3D Printing

    The Intelligent Tools Medical Device Manufacturers Already Own

    MPO's 2023 Medtech Supply Chain Survey
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    A Peek Into the 2028 MPO Summit

    Retail Healthcare Disruptors and Medical Devices

    Six Developments Your Talent Strategy Should Prepare for in 2024

    The Power and Paradox of Never

    Navigating the Q-Sub Program: How Experienced Lab Partners Can Help Streamline Regulatory Submission
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    maxon

    BMP Medical

    Qosina Corp.

    Poly-Med, Inc.

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Telemedicine for Neurology: 5 Benefits of Remote Management

    Machining 101: A Review of Machining Components with a Five-Axis System

    MedTech 2024: Top 5 Trends Shaping a Dynamic Industry

    Early Warning: A Q&A with Abbott's CMO of Heart Failure

    2023 in Review: Medtech's Mega-M&A Is MIA
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    maxon

    BMP Medical

    Qosina Corp.

    Poly-Med, Inc.

    Medbio LLC
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Shimmer's Verisense Wearable Provides Biometric Data for Clinical Trials

    Verisense was designed specifically to improve data quality in clinical trials while reducing the burden on sponsors, sites, and participants.

    Shimmer
    Verisense by Shimmer IMU. Image courtesy of Shimmer.
    Rana Healthcare Solutions LLC02.19.19
    Shimmer, a developer of wearable technology for research applications, announced the launch of Verisense, its next-generation wearable sensor platform designed from the ground up to meet the needs of clinical trial sponsors, sites and participants. This new technology will be unveiled at the SCOPE Summit for Clinical Ops Executives, which will be held from Feb. 19-21 at the Hyatt Regency Orlando in Orlando, Fla.
     
    "There is a growing demand from pharmaceutical companies, regulators and payers to factor real-world data (RWD) into healthcare decision making. They want to ensure that new therapies, especially those for chronic conditions, deliver objective improvements to participants' health and quality of life. That requires access to real-world participant data and has spurred the rapid growth in wearable technologies to measure objective quality of life indicators, such as activity levels and sleep patterns," said Geoff Gill, president of Shimmer Americas.
     
    The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., stated on Dec. 6, 2018 that leveraging RWD to improve regulatory decisions is a key strategic priority for the FDA.1 He also unveiled the FDA's new strategic framework to advance use of real-world evidence (RWE) to support development of drugs and biologics. "RWD and RWE can be especially useful for postmarket monitoring of the safety of products during their use in real-world settings," said Dr. Gottlieb. He added that FDA has "new drug applications under review [in the oncology setting] where RWD and RWE are helping to inform our ongoing evaluation as one component of the total complement of information that we're evaluating."1
     
    "But an effective clinical trial solution has to meet very specific requirements, such as providing access to raw participant data and purpose-built management tools, while placing the minimum burden on sponsors, sites, and participants. This can't be done by simply repurposing consumer wearable devices or other current devices. We started by systematically understanding the needs of sponsors, sites, and participants, then designed Verisense from the ground up to meet those needs," added Gill. "The initial feedback from customers has been overwhelmingly positive. Starting in March, customers are planning to use Verisense in trials for Alzheimer's disease, Parkinson's disease, cancer-related fatigue, and stroke."
     

    Verisense by Shimmer IMU, Base Station, and Cloud. Image courtesy of Shimmer.
    Verisense is a comprehensive and flexible solution for reliably capturing accurate and complete biometric data. Verisense is launching with the Verisense IMU sensor, a general-purpose Inertial Measurement Unit (IMU). Worn on the wrist, it can monitor activity and sleep seamlessly. In addition, it can be used for any IMU application with up to seven sensors worn on different parts of a participant's body, making it invaluable for studying complex musculoskeletal or neurological conditions, such as dystonia or epilepsy. Furthermore, researchers can draw on a wealth of published data and established metrics from more than a decade of research using Shimmer devices.
     
    "I have employed Shimmer sensors successfully in my research for many years, most recently in my work on Parkinson's disease," said Paolo Bonato, Ph.D., director of the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital in Boston, Mass. "The new Verisense platform will allow me to build upon that experience using a device that was specifically developed for remote monitoring, providing access to raw data, offering quick system setup, a robust and secure data flow, and a six-month battery life which will be a boon for patient compliance and improved data quality," he added. Dr. Bonato is also an associate professor in the Department of Physical Medicine and Rehabilitation at Harvard Medical School, and an associate faculty member at the Wyss Institute for Biologically Inspired Engineering, Harvard University.
     
    The Verisense platform provides complete clinical trial sponsor support. Sponsors gain access to all the raw participant data; they are uploaded to a secure site and can be transferred to an electronic data capture system automatically to ensure data integrity. Built-in algorithms provide validated metrics. A monitoring dashboard shows the status of all the sites at a glance and provides the ability to drill down to every sensor in the study.
     
    From the site perspective, Verisense requires just a five-minute setup to initiate data collection and participant follow up if the system alerts them to a critical issue.
     
    The Verisense platform places the minimum burden on participants. After putting the base station near their bed, or in another location that they visit every day, all they need to do is wear the sensor. It can even be worn in the shower or bath. The Verisense battery lasts for up to six months and the data transfer is completely automatic. The Verisense sensor can be inserted into a wide variety of cradles, ensuring that it meets all style and functional requirements.
     
    Reference
    1 Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's new strategic framework to advance use of real-world evidence to support development of drugs and biologics. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627760.htm
    Related Searches
    • research
    • harvard
    • quality
    • sleep
    Related Knowledge Center
    • Patient Monitoring
    Suggested For You
    Know Labs Awarded New Patent for Non-Invasive Diagnostic Tech Platform Know Labs Awarded New Patent for Non-Invasive Diagnostic Tech Platform
    Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices
    Bright Future Ahead for Renal Denervation Bright Future Ahead for Renal Denervation
    Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades
    Philip Morris International Acquires OtiTopic Philip Morris International Acquires OtiTopic
    Early Catheter Ablation of VT Outperforms Conventional Medical Therapy Early Catheter Ablation of VT Outperforms Conventional Medical Therapy
    KA Imaging Forges U.S. Distribution Deal With Alpha Imaging KA Imaging Forges U.S. Distribution Deal With Alpha Imaging
    CARMAT Celebrates First Aeson Artificial Heart Commercial Implant CARMAT Celebrates First Aeson Artificial Heart Commercial Implant
    ClearDATA, BioIntelliSense Collaborate to Enhance RPM Security and Compliance ClearDATA, BioIntelliSense Collaborate to Enhance RPM Security and Compliance
    USMI Developing First Robotic System for Cancer Surgery USMI Developing First Robotic System for Cancer Surgery
    Why is it Suddenly Difficult to Buy Plastic Components in 2021? Why is it Suddenly Difficult to Buy Plastic Components in 2021?
    Medical Device Development: Three Tips for Success Medical Device Development: Three Tips for Success
    The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology
    Medtronic Starts Construction on New Innovation Center Medtronic Starts Construction on New Innovation Center
    Expanded FDA Approval for Medtronic Expanded FDA Approval for Medtronic's Arctic Front Cryoablation Catheter

    Related Breaking News

    • Know Labs Awarded New Patent for Non-Invasive Diagnostic Tech Platform

      Know Labs Awarded New Patent for Non-Invasive Diagnostic Tech Platform

      Company has been granted 22 patents to date and has 35 more pending.
      Business Wire 09.09.21

    • Neurological | Software & IT
      Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices

      Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices

      Algorithm may help understand which brain regions directly interact with one another.
      Mayo Clinic 09.07.21

    • Bright Future Ahead for Renal Denervation

      Bright Future Ahead for Renal Denervation

      No devices yet approved in the United States for the high blood pressure treatment.
      GlobalData 09.02.21


    • Cardiovascular
      Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades

      Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades

      Introduces advanced new mapping algorithms into the AcQMap 3D imaging and mapping system.
      Acutus Medical 08.12.21

    • Cardiovascular
      Philip Morris International Acquires OtiTopic

      Philip Morris International Acquires OtiTopic

      PMI will use the purchase to grow its pipeline of ‘Beyond Nicotine’ inhaled therapeutic products.
      Philip Morris International Inc. 08.11.21

    Loading, Please Wait..

    Breaking News
    • ResMed Scores Legal Wins in Patent Spat with NYU
    • NeuroOne Receives FDA Clearance for Ablation System
    • AdvaMed Names GE HealthCare Leader Peter J. Arduini as Chairman
    • Hologic Promotes Essex D. Mitchell to COO
    • Medtronic, Cosmo Pharmaceuticals Fortify AI-Driven Endoscopy Partnership
    View Breaking News >
    CURRENT ISSUE

    November 2023

    • MPO's 2023 Medical Device Industry Year in Review
    • The Beat Goes On in the Cardiovascular Device Market
    • Medical Manufacturers Gain Support from 3D Printing
    • The Intelligent Tools Medical Device Manufacturers Already Own
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Cognitive Health Tops Charts of Prinova’s 2024 Food/Nutrition Mega-Trends Report
    EpiCor Postbiotic Receives Health Canada Approved Immune, Gut Health Claims
    Women in Nutraceuticals Hires Executive Director Rebecca Takemoto
    Coatings World

    Latest Breaking News From Coatings World

    INEOS Completes Acquisition of Eastman's Acetic Acid Plant in Texas
    DuPont Co-Launches PVF Coating Solution with Nippon Paint
    PPG Brings PPG MOONWALK Automated Paint Mixing System to Mexico
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    NeuroOne Receives FDA Clearance for Ablation System
    AdvaMed Names GE HealthCare Leader Peter J. Arduini as Chairman
    Hologic Promotes Essex D. Mitchell to COO
    Contract Pharma

    Latest Breaking News From Contract Pharma

    RoslinCT to Manufacture CRISPR-based Gene Therapy CASGEVY
    DifGen Pharmaceuticals Acquires KriGen
    Ferring, PharmaBiome Partner on Microbiome R&D
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Bliss Partners with Crunch to Bring Self-Care Skincare to Gym Goers
    Selena Gomez’s Rare Beauty Expands into Scented Body Care Category
    Peach Fuzz is Pantone’s Color of the Year 2024
    Happi

    Latest Breaking News From Happi

    Premium Beauty & Personal Care Products Market: $780.16 Billion by 2032
    Bliss Partners With Crunch Gym
    New Kenvue Study Shows Sunscreen UV Filter Rinse-off Varies
    Ink World

    Latest Breaking News From Ink World

    INEOS Concludes Acquisition of Eastman's Acetic Acid Plant in Texas
    Solvay Concludes Syensqo Spin-off
    Weekly Recap: Siegwerk, DIC, and Müller Martini Top This Week’s Stories
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    CRG promotes Ginnie Gandy to sales manager, Release Liner
    Analyzing the Russian label market, Cartes boosts brands and more
    FLAG’s December Lunch & Learn to feature Omet
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Autoneum Offers Propylat Sustainable Acoustic Technology
    Ahlstrom Announces Change to Board
    Partners Group Acquires Velvet Care
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OssDsign Realigning its Strategy to Focus on Orthobiologics
    ODT's Most-Read Stories This Week—Dec. 9
    Fujitsu, iSurgery Launch Bone Health Promotion Project in Japan
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Zebra Earns Highest Score on CEI
    SEMI Applauds Advancement of US Chips Act Incentives
    Weekly Recap: Schreiner MediPharm, GIANCE and PragmatIC Top This Week’s Stories

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login