• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Top News
    Alleviant's Transcatheter Tech Obtains Breakthrough Status

    Signia Appoints New President

    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

    QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner

    MedAcuity, Fathom Partner on Human Factors Engineering Services
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Medicoil

    Qosina Corp.

    FUTEK Advanced Sensor Technology Inc.

    Medbio LLC

    Spectrum Plastics Group
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    MW Life Sciences

    PTI Engineered Plastics Inc.

    Unicep

    FUTEK Advanced Sensor Technology Inc.

    Medicoil
    • 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
    • Podcasts
    • Resources
    • eBook
    • 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

    FDA Clears SonaCare Medical's Updated HIFU Prostate Tissue Ablation Device

    Over 43 U.S. physicians now offer HIFU prostate tissue ablation to their patients.

    FDA Clears SonaCare Medical
    (Credit: PRNewsFoto/SonaCare Medical, LLC)
    Related CONTENT
    • Baxter and Mayo Clinic Launch R&D Collaboration
    • FDA Grants Market Clearance to New Peripheral Artery Disease Treatment
    • EnteroMedics Acquires the Gastric Vest System
    • Biotheranostics Appoints New CEO
    • Engineering a Kidney-on-a-Chip
    PR Newswire01.11.17
    SonaCare Medical, developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its latest version of Sonablate in the United States. Sonablate was the first HIFU device to receive regulatory authorization from the Food and Drug Administration (FDA) for the focused ablation of prostate tissue.
     
    This improved version of Sonablate technology includes new and updated features such as: Tissue Change Monitoring (TCM), a tool that quantifies RF signals for changes in tissue composition following energy delivery; altered delivery sequences that, in combination with a new and more automated planning system, reduces overall procedure time by as much as 40%; and a modernized look and feel to the software interface. 
     
    "We worked diligently with the FDA to provide clinical data consistent with the requirements established in the de novo authorization SonaCare Medical received for Sonablate in 2015," commented Dr. Mark Carol, chief executive officer. "We are appreciative of the efforts of the FDA to continue to advance the delivery of care for men who may benefit from prostate tissue ablation. Based on the adoption rates of Sonablate in the U.S. in 2016, we expect the placements and acquisitions of our technology to grow dramatically in 2017, bringing this ground-breaking approach to a greater percentage of men in the U.S."
     
    Since Sonablate received FDA clearance on October 09, 2015, there have been over 40 acquisitions of Sonablate technology, including placements at top-tier academic institutions located in California, Indiana, Maryland, New York, and Texas.  Over 43 U.S. physicians now offer HIFU prostate tissue ablation to their patients, and over 700 U.S. patients have selected this minimally-invasive alternative to surgery or radiation.
    Related Searches
    • manufacturer
    • monitoring
    • dr
    • tissue
    Related Knowledge Center
    • Software & IT
    Suggested For You
    Baxter and Mayo Clinic Launch R&D Collaboration Baxter and Mayo Clinic Launch R&D Collaboration
    FDA Grants Market Clearance to New Peripheral Artery Disease Treatment FDA Grants Market Clearance to New Peripheral Artery Disease Treatment
    EnteroMedics Acquires the Gastric Vest System EnteroMedics Acquires the Gastric Vest System
    Biotheranostics Appoints New CEO Biotheranostics Appoints New CEO
    Engineering a Kidney-on-a-Chip Engineering a Kidney-on-a-Chip
    Data Reaffirms Value of LivaNova’s Aortic Valve Replacement Technology Data Reaffirms Value of LivaNova’s Aortic Valve Replacement Technology
    Implanted Biopolymer Scaffold with T Cells Rapidly Shrinks Tumors Implanted Biopolymer Scaffold with T Cells Rapidly Shrinks Tumors
    BD to Acquire Bard for $24 Billion BD to Acquire Bard for $24 Billion
    Defibtech Selects New CEO Defibtech Selects New CEO
    FDA Clears Siemens FDA Clears Siemens' Robot-Supported ARTIS Pheno Angiography System
    Tech Retrains Brain to Ignore Ringing in the Ears Tech Retrains Brain to Ignore Ringing in the Ears
    EDAP to Distribute LABORIE’s Medical Measurement Systems Urodynamic Products in Japan EDAP to Distribute LABORIE’s Medical Measurement Systems Urodynamic Products in Japan
    Intact Vascular Closes on Additional Series B Funding Intact Vascular Closes on Additional Series B Funding
    FDA Grants QT Vascular Full IDE Approval to Begin Pivotal Trial of Drug-Coated Balloon FDA Grants QT Vascular Full IDE Approval to Begin Pivotal Trial of Drug-Coated Balloon
    Harmar Announces Chief Executive Officer Harmar Announces Chief Executive Officer

    Related Breaking News

    • Digital Health | Software & IT
      Philips Buys Capsule Technologies in $635M Deal

      Philips Buys Capsule Technologies in $635M Deal

      Capsule offers vendor-neutral Medical Device Information Platform with an SaaS business model.
      GlobeNewswire 01.19.21

    • Digital Health | Software & IT
      FDA Releases Artificial Intelligence, Machine Learning Action Plan

      FDA Releases Artificial Intelligence, Machine Learning Action Plan

      Outlines FDA’s next steps toward furthering oversight for AI/ML-based "software as a medical device."
      U.S. Food and Drug Administration 01.13.21

    • Software & IT
      Censis Technologies, Cantel Medical Partner on Endoscope Reprocessing Software Solution

      Censis Technologies, Cantel Medical Partner on Endoscope Reprocessing Software Solution

      Companies developing an enhanced integrated workflow solution designed to provide superior infection prevention and practice optimization.
      Business Wire 01.07.21


    • Patient Monitoring | Software & IT
      AI Metrics

      AI Metrics' Liver Imaging Software Earns FDA Nod

      Early-stage startup approved for low-cost, low-risk, non-invasive procedures for chronic liver disease patients.
      University of Alabama at Birmingham 12.09.20

    • Diagnostics | Software & IT
      FDA OKs Hologic

      FDA OKs Hologic's Genius AI Breast Cancer Detection Software

      New deep-learning algorithm helps radiologists detect breast cancers in their early stages.
      Business Wire 12.01.20

    • Diagnostics | Software & IT
      RSNA News: Royal Philips Introduces IntelliSpace Portal 12

      RSNA News: Royal Philips Introduces IntelliSpace Portal 12

      A next-gen Advanced Visualization Workspace with AI capabilities.
      Royal Philips 11.30.20


    • Software & IT
      GE Healthcare Launches X-ray AI for COVID-19 Patients

      GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement

      A necessary and important step when ventilating critically ill COVID-19 patients.
      Business Wire 11.23.20

    • Software & IT
      BD Acquires CUBEX

      BD Acquires CUBEX's Medical Business

      Broadens automated dispensing portfolio across care continuum.
      PR Newswire 11.12.20

    • Digital Health | Software & IT
      GE Healthcare Introduces Edison HealthLink

      GE Healthcare Introduces Edison HealthLink

      New edge technology is designed to give clinicians rapid access to critical data.
      PR Newswire 10.14.20


    • Software & IT | Surgical
      iotaMotion Completes First Cochlear Implant Surgeries Using iotaSOFT System

      iotaMotion Completes First Cochlear Implant Surgeries Using iotaSOFT System

      Gathers clinical evidence in support of the safety & performance of its investigational surgical tool.
      PRNewswire 09.29.20

    • Software & IT
      FDA OKs Varian

      FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software

      Integration of Dual Energy CT images in planning process reduces range uncertainty and helps clinicians spare healthy tissue.
      PR Newswire 09.16.20

    • Diagnostics | Digital Health | Software & IT
      QIAGEN Expands Integrated NGS Software Solutions to Speed COVID-19 Research

      QIAGEN Expands Integrated NGS Software Solutions to Speed COVID-19 Research

      QIAseq SARS-CoV-2 Primer Panel converts viral RNA samples into libraries ready for sequencing.
      QIAGEN 08.19.20


    • Cardiovascular | Diagnostics | Neurological | Software & IT
      RapidAI

      RapidAI's RapidLVO Earns FDA Nod to Spot Large Vessel Occlusions

      Rapid LVO helps physicians speed up triage or transfer decision-making.
      Business Wire 08.14.20

    • Chronic Disease | Diagnostics | Software & IT
      Eyenuk

      Eyenuk's Autonomous AI for Diabetic Retinopathy Screening Wins FDA Nod

      First FDA cleared AI technology for autonomous detection of both more than mild and vision-threatening diabetic retinopathy.
      Business Wire 08.07.20

    • Software & IT
      DELMIAworks Appoints New CEO

      DELMIAworks Appoints New CEO

      Cheri Williams brings nearly 30 years of experience.
      DelmiaWorks 07.30.20


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    Breaking News
    • Alleviant's Transcatheter Tech Obtains Breakthrough Status
    • Signia Appoints New President
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    • MedAcuity, Fathom Partner on Human Factors Engineering Services
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    NIH Study Compares Low-Fat, Plant-Based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    APV Engineered Coatings Reflects on 2020
    LINE-X Launches Dealer Program with International Truck
    Mankiewicz Announces Leadership Change in Aviation Division
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Alleviant's Transcatheter Tech Obtains Breakthrough Status
    Signia Appoints New President
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia
    Humanigen, Emergent Enter Covid-19 Partnership
    Samsung Bioepis Opens New Headquarters
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    e.l.f. Cosmetics Unveils Mint Melt Collection
    Estée Lauder Companies Updates Supply Chain Leadership
    Weekly Recap: JLo Beauty Launches, Unilever Partners with Alibaba, Estée Lauder Appoints SVP & More
    Happi

    Latest Breaking News From Happi

    Degree Launches Bath and Shower Range
    Estée Lauder Companies Updates Supply Chain Leadership
    Clorox Reaches Renewable Electricity Marker
    Ink World

    Latest Breaking News From Ink World

    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    VPF launches deep-freeze adhesive
    ProMach strengthens flexible packaging business
    Gallus planning virtual event for March
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System
    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    Osram in Top 25 of World’s 100 Most Sustainable Companies
    Graphene Flagship Study Predicts Increased Market Penetration by 2025

    Copyright © 2021 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