• 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 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    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
    3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution

    Zeus Introduces Absorv XSE Oriented Tubing

    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access

    Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz

    Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Back to School for Medical Device Cybersecurity Training

    Driving Clinical Trial Excellence to Help Study Teams Run a Faster Relay Race

    Medtech’s Supply Chain: From Disruption to Opportunity

    Are Medtech’s Mega-Deals Gone For Good?

    Will a Skilling Gap Hinder Organizational Readiness for Medtech’s New Age of AI?
    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
    JBC Technologies

    Halkey-Roberts Corporation

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The

    Johari Digital Healthcare Ltd.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Wearables Are Changing the Way We Collect Real-World Data in Clinical Trials

    Could Medtech Ever Stop a Hospital Killer in Their Tracks?

    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    Halkey-Roberts Corporation

    LEMO USA Inc.

    Arthur G. Russell Co. Inc., The

    Johari Digital Healthcare Ltd.
    • 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

    Subtle Medical's SubtlePET Gains FDA Clearance & CE Mark

    SubtlePET is the first AI product cleared for medical imaging enhancement.

    Subtle Medical
    Image courtesy of PRNewsfoto/Subtle Medical Inc.
    PR Newswire12.05.18
    Subtle Medical, a privately-held medical device company focused on improving medical imaging efficiency and patient experience with innovative deep learning imaging technologies, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtlePET. Subtle Medical also recently secured approval to affix the CE mark on SubtlePET to begin marketing in the European Economic Area without restrictions.
     
    SubtlePET's artificial intelligence (AI)-powered technology allows hospitals and imaging centers to enhance images from faster scans leading to an improved patient experience during imaging procedures while boosting exam throughput and provider profitability. SubtlePET is currently in pilot clinical use in multiple university hospitals and imaging centers in the U.S. and abroad.
     
    "Focusing Subtle Medical's SubtlePET AI platform on faster image acquisition, we have been able to dramatically increase PET scan efficiency and provide a superior patient experience. SubtlePET technology allows us to scan a patient four times faster than normal, yet maintain equal image quality, not otherwise impacting workflow," said Michael Brant-Zawadzki, M.D., FACR, Hoag Hospital, Newport Beach, Calif. "This creates immediate ROI benefit for our hospital and a compelling value proposition. I'm looking forward to seeing more groundbreaking technology from the Subtle team."
     
    Subtle Medical's AI solution enables completion of more exams in a day compared to conventional PET imaging without the need for capital expenditures. It reduces patient time in the scanner and helps hospitals and imaging centers enhance their bottom line in today's competitive healthcare environment. The company's technology utilizes deep learning algorithms that integrate seamlessly with any OEM scanner and PACS system to enhance images during acquisition without any interruption or alteration in the imaging specialists' workflow. SubtlePET delivers a significant improvement in the image quality of noisy images resulting from shorter scans, which is particularly beneficial for children and those undergoing repeat PET exams.
     
    SubtlePET is the first product in Subtle Medical's growing portfolio of new AI technologies to receive FDA clearance. "This FDA clearance is a key milestone in Subtle Medical's mission to bring novel and empathetic deep learning to improve patient satisfaction," said Enhao Gong, Ph.D., founder and CEO of Subtle Medical. "The accomplishment of having the first AI cleared for use in nuclear medicine applications validates our team's strength and the commitment of our collaborators. Our focus on image acquisition and workflow differentiates us from other AI companies that are working on post-processing and computer-aided diagnosis products. We are not replacing radiologists--we are addressing the tremendous cost to U.S. healthcare by leveraging deep learning in imaging at the infrastructure level to enable better and higher quality care."
     
    Subtle Medical is developing additional products to be submitted for FDA clearance. A second product currently undergoing clinical evaluation is SubtleMR, which allows imaging centers to significantly accelerate MRI scans using the company's AI solutions. SubtleGAD is also being developed to reduce gadolinium dosage during imaging procedures.
     
    In March 2018, Subtle Medical received the NVIDIA Inception Award for Top Healthcare+AI Startup Globally selected from over 3,000 AI contenders. The company was also selected as the first AI+healthcare startup for Bessemer Venture Partners' Deep Health Seed Program. Most recently, it was named as a 2018 Minnies Award semi-finalist for Best New Radiology Vendor by AuntMinnie.com.
    Related Searches
    • medical
    • it
    • first
    • clearance
    Related Knowledge Center
    • Patient Monitoring
    • Diagnostics
    • Software & IT
    Suggested For You
    Canon Medical Systems, Zebra Medical Vision Collaborate on AI Offerings Canon Medical Systems, Zebra Medical Vision Collaborate on AI Offerings
    GE Healthcare Unveils Voluson SWIFT AI-Enhanced Women’s Health Ultrasound GE Healthcare Unveils Voluson SWIFT AI-Enhanced Women’s Health Ultrasound
    Abbott Abbott's FreeStyle Libre 3 Receives CE Mark
    Endologix Receives CE Mark for ALTO Abdominal Stent Graft System Endologix Receives CE Mark for ALTO Abdominal Stent Graft System
    AI Could Expand Healing with Bioscaffolds AI Could Expand Healing with Bioscaffolds
    Abbott’s MitraClip G4 Receives CE Mark Abbott’s MitraClip G4 Receives CE Mark
    Varex Imaging Welcomes New Finance Chief Varex Imaging Welcomes New Finance Chief
    Smartphone-Controlled Wearable for Migraines Gains CE Mark Smartphone-Controlled Wearable for Migraines Gains CE Mark
    FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector
    Former EOS Imaging CEO Appointed to EDAP TMS Board Former EOS Imaging CEO Appointed to EDAP TMS Board
    Guided Therapeutics LuViva Advanced Cervical Scan Wins New CE Mark With Expanded Claims Guided Therapeutics LuViva Advanced Cervical Scan Wins New CE Mark With Expanded Claims
    CorTechs Labs, Subtle Medical Forge Distribution Partnership CorTechs Labs, Subtle Medical Forge Distribution Partnership
    FDA Clears Siemens Healthineers AI-Based Software FDA Clears Siemens Healthineers AI-Based Software
    RadNet, Hologic Collaborate on AI for Breast Health RadNet, Hologic Collaborate on AI for Breast Health
    Eyenuk Eyenuk's Autonomous AI for Diabetic Retinopathy Screening Wins FDA Nod

    Related Breaking News

    • Canon Medical Systems, Zebra Medical Vision Collaborate on AI Offerings

      Canon Medical Systems, Zebra Medical Vision Collaborate on AI Offerings

      Integration marks the introduction of Zebra-Medical’s solution into the modality space.
      Business Wire 09.30.20

    • Patient Monitoring
      GE Healthcare Unveils Voluson SWIFT AI-Enhanced Women’s Health Ultrasound

      GE Healthcare Unveils Voluson SWIFT AI-Enhanced Women’s Health Ultrasound

      Industry-first auto recognition tools help improve efficiency.
      GE Healthcare 09.30.20

    • Chronic Disease
      Abbott

      Abbott's FreeStyle Libre 3 Receives CE Mark

      Features world's smallest, thinnest sensor with best-in-class performance at the same low cost for people with diabetes.
      PR Newswire 09.28.20


    • Endologix Receives CE Mark for ALTO Abdominal Stent Graft System

      Endologix Receives CE Mark for ALTO Abdominal Stent Graft System

      Product provides patients and physicians with an endograft capable of treating the highest proportion of patients within its indications for use.
      Business Wire 09.25.20

    • 3D/Additive Manufacturing | Materials
      AI Could Expand Healing with Bioscaffolds

      AI Could Expand Healing with Bioscaffolds

      Rice engineers use machine learning to speed bioscaffold development.
      Mike Williams, Rice University 09.24.20

    Loading, Please Wait..

    Trending
    • Cardiosense Begins SEISMIC-HF I Heart Failure Trial
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • Exo Introduces The Exo Iris To Market
    • A New Approach To Post-Market Surveillance
    • Varian Buys Aspekt Solutions To Bolster Advanced Oncology Biz
    Breaking News
    • 3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
    • Zeus Introduces Absorv XSE Oriented Tubing
    • Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
    • Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz
    • Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
    View Breaking News >
    CURRENT ISSUE

    October 2023

    • MPO's 2023 Medtech Supply Chain Survey
    • Exceeding Medical Device Extrusion Expectations
    • Medical Device Micromolders Discuss the 'Minor Details'
    • 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

    PLT Health Solutions Granted Claims for Botanical Ingredient in Canada
    CRN Files Petition with FTC For Clarity on Health Products Compliance Guidance
    Vitafoods Europe Relocates to Barcelona Starting 2025
    Coatings World

    Latest Breaking News From Coatings World

    Arkema Will Decarbonize Acrylics Production at its Carling, France Site
    PPG to Announce Third-Quarter 2023 Results October 18
    IGL Coatings Partners with DHL Express
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
    Zeus Introduces Absorv XSE Oriented Tubing
    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ono, Admid Partner on Novel Antibody Drugs in Oncology
    Theradaptive Awarded DOD Clinical Trial Award of up to $7.4M
    Ginkgo Bioworks, Pfizer Enter Multi-Target RNA Discovery Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    NYX Professional Makeup Partners with the New York Liberty
    BASF and StitchCrew Introduce Educational Bootcamp for Indigenous Beauty Brands
    Top 10 Most Popular Fashion Designer Makeup Brands—According to Landys Chemist
    Happi

    Latest Breaking News From Happi

    Evoke the Beauty of Spring with Epopack
    Micro Powders Appoints IMCD US New Regional Distributor for Personal Care Products
    American Cleaning Institute Praises Draft Proposal on Cleaning Product Ingredient Transparency
    Ink World

    Latest Breaking News From Ink World

    Arkema Will Decarbonize Acrylics Production at Carling, France Site
    Micro Powders Showcases New Natural, PTFE Alternative Additives at 2023 WCS
    Roland DG Direct-To-Film Printer Ink, Powder Receive ECO PASSPORT Certification
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    INX brings inkjet and sustainable packaging to PRINTING United Expo
    Schreiner MediPharm introduces Freeze-Light-Protect syringe label
    Kodak launches PRINERGY 10.0
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    ExxonMobil Works with JL Goor to Help Drive Growth in Ireland and U.K. Healthcare Sector
    Lee C. Stewart Resigns from Glatfelter Board
    Ana Fraisse Joins The American Cleaning Institute
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    CTL Amedica Granted ECAT Approval from Defense Logistics Agency
    Intech Acquires Lenkbar LLC
    ONWARD Completes First-in-Human for ARC-IM to Restore Upper Extremity Function
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Wiliot to Show Enhanced Version of Wiliot Cloud, IoT Pixels, at MWC Las Vegas 2023
    Fraunhofer FEP Integrable Solution for 2D Inline Process Monitoring
    Jabil Announces Definitive Agreement to Divest Mobility Business for $2.2B

    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