• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser

    Pancryos Forges License Agreement for Microencapsulation Device

    FDA Awards IDE Approval to SELUTION SLR Drug-Eluting Balloon

    Matt Rainville Joins Bigfoot Biomedical as Chief Commercial Officer

    ENDRA Life Sciences Issued 27th Patent
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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
    Concise Engineering

    Cirtec Medical

    BMP Medical

    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    ‘Right to Repair’: Separating Fact from Fiction

    Taking a Holistic Approach to Decentralized Clinical Trials (DCTs)

    Investment in Health Startups Drops

    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Concise Engineering

    Cirtec Medical

    BMP Medical

    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.
    • 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

    Retinal Imaging Platform to Support Alzheimer's Diagnosis Gains Breakthrough Status

    Optina Diagnostics' platform uses AI to analyze data-rich hyperspectral retinal images captured with a metabolic hyperspectral retinal camera during an eye test.

    Retinal Imaging Platform to Support Alzheimer
    Related CONTENT
    • Breakthrough Device Designation Granted for New Neuromodulation Platform
    • Improved Outcomes Proven With Insulet’s Omnipod 5 System
    • Vertigo Treatment Receives FDA Breakthrough Device Designation
    • Vicarious Surgical Opens New Corporate Headquarters in Massachusetts
    • CVRx Completes First Procedure With Ultrasound-Guided Implant Approach
    PR Newswire05.09.19
    Optina Diagnostics announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2). Optina Diagnostics' platform uses Artificial Intelligence (AI) to analyze the data rich hyperspectral retinal images captured with the MHRC during a simple eye scan. Optina Diagnostics' platform is intended for the detection of likely positron-emission tomography (PET) amyloid status (negative or positive), to aid in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Optina Diagnostics' platform is an adjunct to other diagnostic evaluations.
     
    Amyloid PET is the standard method for the detection of amyloid plaques in the brain, a key hallmark of Alzheimer's disease, and may be useful to confirm the diagnosis and optimize the patient management of patients being evaluated of Alzheimer's disease and other causes of cognitive decline. However, amyloid PET is an expensive technique of limited accessibility. In clinical practice, therefore, the diagnosis of Alzheimer's disease is mostly based on clinical symptoms, without evaluation of the amyloid status, which leads to incorrect diagnosis for nearly one third of the patients presenting at the memory clinic with cognitive impairment and half of those presenting with ambiguous cases.
     
    Optina Diagnostics is working towards a non-invasive and more accessible means via a simple eye imaging test to improve the diagnosis accuracy and management of patients evaluated for Alzheimer's disease or other form of cognitive decline.
     
    "We are excited to receive this Breakthrough Device Designation from the FDA as it recognizes the potential benefits the Optina Diagnostics' platform could bring to clinicians, their patients and families in the diagnosis of Alzheimer's disease and will permit to expedite its development and regulatory approval in the U.S." said David Lapointe, CEO of Optina Diagnostics. "Optina Diagnostics' technology based on data-rich hyperspectral retinal imaging combined with AI opens tremendous possibilities to have insights into the brain non-invasively and at a low cost. The Optina Diagnostics technology could also be helpful to accelerate and reduce the cost for the enrollment of participants that are really on the Alzheimer's path to conduct clinical trials for disease-modifying drugs for Alzheimer's disease."
     
    The Breakthrough Device Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversible debilitating diseases or conditions. This program is designed to expedite the development and review of these medical devices.
     
    Alzheimer's disease is the most common type of dementia, which affects the ability to think, reason and remember clearly, and is the most frequent cause of institutionalization for long-term care. This progressive degenerative brain disease is ultimately fatal, as no disease-modifying treatment currently exits to delay its progression. Nowadays, more than 50 million people are diagnosed with Alzheimer's or a related dementia. It is listed as the sixth-leading cause of death in the United States. The prediction is that by 2050, the number of people suffering from Alzheimer's disease will triple, affecting 14 million people in the US alone, due to aging population demographics. Early detection of this disease is Optina Diagnostics' principal mission.
     
    References
    1 CAPRS: Cerebral Amyloid Predictor Retina Scan
    2 MHRC: Metabolic Hyperspectral Retinal Camera
    Related Searches
    • camera
    • diagnosis
    • artificial intelligence
    • eye
    Related Knowledge Center
    • Software & IT
    • Neurological
    • Diagnostics
    Suggested For You
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Improved Outcomes Proven With Insulet’s Omnipod 5 System Improved Outcomes Proven With Insulet’s Omnipod 5 System
    Vertigo Treatment Receives FDA Breakthrough Device Designation Vertigo Treatment Receives FDA Breakthrough Device Designation
    Vicarious Surgical Opens New Corporate Headquarters in Massachusetts Vicarious Surgical Opens New Corporate Headquarters in Massachusetts
    CVRx Completes First Procedure With Ultrasound-Guided Implant Approach CVRx Completes First Procedure With Ultrasound-Guided Implant Approach
    Abiomed Abiomed's Impella ECP Heart Pump Granted Breakthrough Status
    BioFourmis BioFourmis' Digital Heart Failure Therapeutic Earns Breakthrough Status
    Endologix Launches ALTO Abdominal Stent Graft System in Canada, Argentina Endologix Launches ALTO Abdominal Stent Graft System in Canada, Argentina
    Abiomed Buys preCARDIA, a Heart Failure Tech Firm Abiomed Buys preCARDIA, a Heart Failure Tech Firm
    Varian Varian's Cardiac Radioablation System Earns Breakthrough Status
    FDA Grants Breakthrough Device Status to Epilepsy Treatment System FDA Grants Breakthrough Device Status to Epilepsy Treatment System
    Endologix Acquires PQ Bypass Endologix Acquires PQ Bypass
    Algorithm Can Predict Acute Kidney Injury Sooner Than Hospital Systems Algorithm Can Predict Acute Kidney Injury Sooner Than Hospital Systems
    Berlin Heals Berlin Heals' C-MIC Heart Failure Implant Achieves Breakthrough Device Status
    Encora Encora's Tremor Reducing Wristband Gains Breakthrough Status

    Related Breaking News

    • Breakthrough Device Designation Granted for New Neuromodulation Platform

      Breakthrough Device Designation Granted for New Neuromodulation Platform

      In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.
      Business Wire 09.22.21

    • Improved Outcomes Proven With Insulet’s Omnipod 5 System

      Improved Outcomes Proven With Insulet’s Omnipod 5 System

      Studies show the automated insulin delivery system improved HbA1c nearly one percentage point in kids and 0.60 percent in adolescents and adults.
      Business Wire 09.16.21

    • Vertigo Treatment Receives FDA Breakthrough Device Designation

      Vertigo Treatment Receives FDA Breakthrough Device Designation

      The device's developer—Otolith Labs—closes $3.3 million in seed financing.
      Business Wire 09.13.21


    • Vicarious Surgical Opens New Corporate Headquarters in Massachusetts

      Vicarious Surgical Opens New Corporate Headquarters in Massachusetts

      The new space houses a full-scale operating room for robotics testing as well as R&D and company operations.
      Business Wire 09.09.21

    • Cardiovascular
      CVRx Completes First Procedure With Ultrasound-Guided Implant Approach

      CVRx Completes First Procedure With Ultrasound-Guided Implant Approach

      The new approach is the latest advancement in Barostim for treating heart failure symptoms.
      Globe Newswire 08.26.21

    Loading, Please Wait..

    Trending
    • Siemens Healthineers & The Ohio State University Wexner Medical Center Enter Strategic Partnership
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • ‘Right To Repair’: Separating Fact From Fiction
    • 7 Steps To Create Your Own Medical Device Marketing Plan
    Breaking News
    • OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser
    • Pancryos Forges License Agreement for Microencapsulation Device
    • FDA Awards IDE Approval to SELUTION SLR Drug-Eluting Balloon
    • Matt Rainville Joins Bigfoot Biomedical as Chief Commercial Officer
    • ENDRA Life Sciences Issued 27th Patent
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Pharmavite Expands in Ohio with $200 Million Investment
    Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company
    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products
    Coatings World

    Latest Breaking News From Coatings World

    Azelis Acquires Chemical Partners, Strengthens Leadership in Africa and Middle East
    Emmanuelle Bromet Named Arkema Sustainable Development VP
    ROSS Planetary Dual Dispersers Have Unique Processing Flexibility
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser
    Pancryos Forges License Agreement for Microencapsulation Device
    FDA Awards IDE Approval to SELUTION SLR Drug-Eluting Balloon
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bayer Opens New Research and Innovation Center at Kendall Square
    Lonza Names Maria Soler Nunez as Head, Group Operations
    Eurofins DiscoverX Opens Shanghai Office
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Dexlevo Introduces Beauty Treatment technique, ‘GOURI’
    Revision Skincare Exec Wins Ernst & Young Entrepreneur of the Year
    Latest Updates About Cosmoprof North America
    Happi

    Latest Breaking News From Happi

    Toning Collection For Zero-Brass Blondes is New at Colorproof
    Esthetician Studio Beauty Concepts Files Trademark Infringement Lawsuit Against Kim Kardashian and Coty, Inc.
    Joy Liquid Dishwash Brand Expands Into Auto Dish Market
    Ink World

    Latest Breaking News From Ink World

    Azelis Acquires Chemical Partners, Adds to Leadership in Africa and Middle East
    International Paper Publishes 2021 Sustainability Report
    Epson Now Shipping New SureColor P8570D 44-Inch Production Photo and Graphics Printer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    UPM Raflatac boosts operations in US, All4Labels returns to HP and more
    Fedrigoni Self-Adhesives to exhibit at Labelexpo Americas for first time
    CELAB Europe wins Paper Recycling award
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Glatfelter, Blue Ocean Closures Partner with Absolut
    What You’re Reading on Nonwovens-Industry.com
    Daio, Livedo Partner to Recycle Diapers
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    NuVasive Inc. Opens Singapore Experience Center
    Pedicle Screw Systems Market to Top $3B in 2027
    3Spine Completes First U.S. Surgeries in IDE Pivotal Clinical Trial
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Epishine is Building a New Solar Cell Factory in Linköping, Sweden
    Toppan Establishes CVC Fund and Investment Management Company in the US
    EU-Consortium FlexFunction2Sustain Creates World’s First OPV Cell on Recycled Material

    Copyright © 2022 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