• 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
    Paragonix Reveals Nationwide Organ Procurement Network

    Covalon Technologies Appoints Interim CEO

    GE HealthCare's Pneumothorax Algorithm Earns FDA Nod

    Viz.ai Accelerating Clinical Trial Recruitment for Heart Failure

    Apyx Welcomes Matthew Hill as Finance Chief
    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
    Providence Enterprise USA Inc.

    JBC Technologies

    BMP Medical

    Johari Digital Healthcare Ltd.

    Qosina Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Early Warning: A Q&A with Abbott's CMO of Heart Failure

    2023 in Review: Medtech's Mega-M&A Is MIA

    2023 in Review: Philips Breathes No Easier in Respiratory Recall

    2023 in Review: The Legacy of Elizabeth Holmes

    2023 in Review: A Clean Start for EtO
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Providence Enterprise USA Inc.

    JBC Technologies

    BMP Medical

    Johari Digital Healthcare Ltd.

    Qosina Corp.
    • 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

    inui Health Announces the First Clinical Grade Diagnostics Test Accessible From a Smartphone

    The platform immediately displays various diagnostic tests results and has been validated in multiple clinical studies.

    inui Health Announces the First Clinical Grade Diagnostics Test Accessible From a Smartphone
    inui Health delivers a cost-effective, clinically accurate healthcare diagnostics test in a less expensive, more convenient manner than traditional urine analysis methods. Image courtesy of inui Health.
    Business Wire10.22.18
    inui Health, a Silicon Valley digital health company, has announced the launch of its flagship diagnostics in-home urine analysis platform. The diagnostic platform, which includes a disposable test and smartphone app (iOS and Android), has received 510(k) clearance and a Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA), plus a CE Mark certification. The tests have been used in multiple clinical studies in the United States and Africa and were also validated in Europe and the Middle East, where inui has brought modern lab testing directly to patients in remote villages far from the nearest hospital.
     
    inui Health delivers a cost-effective, clinically accurate healthcare diagnostics test in a less expensive, far more convenient manner than traditional urine analysis methods. To immediately view the results of inui’s diagnostic test, users simply dip and use the phone guided app to conduct the test. The inui diagnostic system measures protein, glucose, leukocytes, nitrites and ketones in urine and it can be used to monitor general health, kidney function, metabolic disorders (e.g. diabetes mellitus) and screen for urinary tract infections (UTI).
     
    “We see an unprecedented opportunity in bringing powerful diagnostic tests currently only available at labs or clinics to the hands of consumers,” said Jaime Tenedorio, CEO of inui Health. “We are enabling individuals to perform these tests anywhere in the world, from Manhattan to sub-Saharan Africa, empowering individuals to know more and worry less about their health. At inui, we are excited to bring the diagnostic lab to areas with no laboratories or limited medical facilities.”
     
    inui Health allows users to:
    • Be empowered to take their healthcare into their own hands.
    • Conduct clinical-grade urine analysis testing anywhere in the world; these tests were previously available only at a lab or a clinical setting.
    • Receive personalized health data when it matters most—inui works across 12 mobile platforms and test results are interpreted and displayed within one minute.
    • Share their results via a HIPPA compliant system with healthcare providers remotely and stage timely interventions.
    • Be confident in the quality of the results, which have been validated through rigorous trials during the FDA and CE Mark approval processes.
     
    inui Health’s vision is to bring diagnostic capabilities to consumers’ hands in order to provide them with medical-grade information. Urine testing is a non-invasive, medically rich diagnostic test that can yield powerful information about someone’s health. The clearance of inui by the FDA represents a major milestone in achieving the company’s bold vision. The inui urine analysis platform will soon be able to deliver an even broader range of diagnostic results.

    “We are entering a market that has a few competitors with limited offerings, but none of them have received the type of FDA approval to deliver such a wide range of diagnostic results to both patient and physician simultaneously with our convenience and low cost,” said Reza Kazemipour, chief revenue officer at inui. “We are ensuring that our generation will be the last to know so little about our health.”
     
    inui Health, headquartered in Silicon Valley, with offices in Boston, Mass., and Dubai, UAE, is a consumer medical devices company with the vision of providing consumers with universally accessible, medical-grade information anytime, anywhere. Venture backed by world class investors which include: Relay Ventures, Redmile Group, Laboratory Corporation of America (Lab Corp.), Tencent Holdings Limited, Fosun Pharma, iGlobe Partners and Three Leaf Ventures. inui is building a suite of products that help consumers detect complications early, monitor their health, share their health information with their healthcare providers to stage timely interventions and know more and worry less about their health.
    Related Searches
    • first
    • ct
    • ceo
    • clearance
    Related Knowledge Center
    • Digital Health
    • Diagnostics
    Suggested For You
    MedAutonomic Implants Brain Neuromodulation Device Through Endoscopic Procedure MedAutonomic Implants Brain Neuromodulation Device Through Endoscopic Procedure
    FDA Approves New DNA-Based Test to Determine Blood Compatibility FDA Approves New DNA-Based Test to Determine Blood Compatibility
    Embolx Earns CE Mark Certification for Sniper Balloon Occlusion Microcatheters Embolx Earns CE Mark Certification for Sniper Balloon Occlusion Microcatheters
    FDA Clears Surgical Innovation Associates FDA Clears Surgical Innovation Associates' Bioabsorbable Mesh for Reconstructive & Cosmetic Surgery
    Hebron Technology Collaborating With Two U.S. Companies on Medical Device Projects Hebron Technology Collaborating With Two U.S. Companies on Medical Device Projects
    17. Alcon (Novartis AG) 17. Alcon (Novartis AG)
    Asahi Intecc Buys RetroVascular Asahi Intecc Buys RetroVascular
    Embolx Signs Agreement With U.S. Government for Sniper Balloon Occlusion Microcatheter Embolx Signs Agreement With U.S. Government for Sniper Balloon Occlusion Microcatheter
    FDA Approves Medtronic FDA Approves Medtronic's 200 & 250mm IN.PACT Admiral Drug Coated Balloons
    Senseonics and Beta Bionics Partner to Develop the Bionic Pancreas System Senseonics and Beta Bionics Partner to Develop the Bionic Pancreas System
    Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry Top 5 of the Past 15: Moments that Shifted, Shaped, or Shook the Medical Device Industry
    Neural Response Panel to Identify Opioid Dependency Risk Wins FDA Breakthrough Designation Neural Response Panel to Identify Opioid Dependency Risk Wins FDA Breakthrough Designation
    FDA Green Lights First Ever Artificial Iris FDA Green Lights First Ever Artificial Iris
    FDA Initiates Device Development Challenge to Help Combat Opioid Crisis FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
    3 Critical Considerations for U.S. Medical Device Commercialization 3 Critical Considerations for U.S. Medical Device Commercialization

    Related Breaking News

    • MedAutonomic Implants Brain Neuromodulation Device Through Endoscopic Procedure

      MedAutonomic Implants Brain Neuromodulation Device Through Endoscopic Procedure

      The Phoenix is implanted with a digestive endoscope, and power is generated without a battery.
      Business Wire 10.19.18

    • Diagnostics
      FDA Approves New DNA-Based Test to Determine Blood Compatibility

      FDA Approves New DNA-Based Test to Determine Blood Compatibility

      ID CORE XT Test streamlines blood compatibility testing, provides an additional alternative to testing blood with antisera.
      U.S. Food and Drug Administration 10.16.18

    • Embolx Earns CE Mark Certification for Sniper Balloon Occlusion Microcatheters

      Embolx Earns CE Mark Certification for Sniper Balloon Occlusion Microcatheters

      Product is designed for pressure-directed treatment of tumors, enlarged prostate, and fibroids.
      Business Wire 10.05.18


    • Surgical
      FDA Clears Surgical Innovation Associates

      FDA Clears Surgical Innovation Associates' Bioabsorbable Mesh for Reconstructive & Cosmetic Surgery

      Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue.
      Business Wire 09.07.18

    • Hebron Technology Collaborating With Two U.S. Companies on Medical Device Projects

      Hebron Technology Collaborating With Two U.S. Companies on Medical Device Projects

      Hebron pursuing technologies in hearing aids, diagnostic medical equipment.
      Globe Newswire 08.31.18

    Loading, Please Wait..

    Breaking News
    • Paragonix Reveals Nationwide Organ Procurement Network
    • Covalon Technologies Appoints Interim CEO
    • GE HealthCare's Pneumothorax Algorithm Earns FDA Nod
    • Viz.ai Accelerating Clinical Trial Recruitment for Heart Failure
    • Apyx Welcomes Matthew Hill as Finance Chief
    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

    IFT, Seeding the Future Foundation Announce Grants and Awards
    Bioriginal Acquires Softgel Co. to Expand Nutrition Product Line
    Beauty Brand Genaura to Launch Product Line Featuring Gencor’s Levagen+
    Coatings World

    Latest Breaking News From Coatings World

    Advancion Launches Multi-Functional Etheramie for Waterborne Industrial Coatings
    Acme-Hardesty Achieves EcoVadis Silver Medal
    Early Bird Registration for Waterborne Symposium Ends December 2
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Paragonix Reveals Nationwide Organ Procurement Network
    Covalon Technologies Appoints Interim CEO
    GE HealthCare's Pneumothorax Algorithm Earns FDA Nod
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Schreiner MediPharm Introduces New Smart Blister Wallet
    Charles River, GC4K Enter Gene Therapy Mfg. Pact
    RSSL Opens State-of-the-Art Analytical Testing Facility
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    WGSN Unveils Top Beauty Trends for 2024 and Beyond
    Huda Kattan Calls Out the Beauty Industry as Sexist
    L’Occitane H1 Sales Up 19%, Driven by Sol de Janeiro and Elemis
    Happi

    Latest Breaking News From Happi

    BASF Launches New Biodegradable, Anti-Redeposition Polymer
    Net Sales Grow 19% For L’Occitane International SA Per FY2024 Interim Results
    Henkel Recognizes Female Researchers with Martha Schwarzkopf Award for Women in Science
    Ink World

    Latest Breaking News From Ink World

    Flexo Ink Market is Anticipated to Reach $7.7B by 2031: TMR
    Acme-Hardesty Earns EcoVadis Silver Medal
    Flint Group, All4Labels Partner with EkoCure Dual Cure Inks
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Flexcon Global adds James Slaughter to team
    Independent II boosts packaging capabilities with Domino
    Avery Dennison announces atma.io updates
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Natureworks Names New CEO
    Gessner Offers Craneglas for the Battery Market
    UAE Baby Care Brand PureBorn Inks Distribution Deal with Laboratoire Naturel
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Spinal Elements Rolls Out Ventana 3D-Printed Interbodies
    Massimo Calafiore Named Orthofix President and CEO
    Exactech Study Shows Fairness, Accuracy of Predict+ for Shoulder Surgery
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    LG to Present Innovative Solutions for a Better Life at CES 2024
    BOE Technology Group, Universal Display Sign Long-Term OLED Agreements
    Linxens, PalmSens Partner on Reproducible Gold Electrode

    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