• 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
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    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
    The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer

    Coloplast Launches New Catheter in the U.S.

    Josh Ghaim and Sachin Jain Join Cue Health Board of Directors

    NAMSA Relaunches Medtech Outsourcing Solution

    Rollomatic Inc. Welcomes Joe Kane as CEO
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    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
    Paragon Medical

    Medbio LLC

    Arthur G. Russell Co. Inc., The

    Forefront Medical Technology

    LEMO USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Paragon Medical

    Medbio LLC

    Arthur G. Russell Co. Inc., The

    Forefront Medical Technology

    LEMO USA 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

    Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance

    Bruin Biometrics' SEM Scanner directs clinicians to heels and sacrums at risk of developing pressure ulcers, even before the damage is visible.

    Related CONTENT
    • Aziyo Biologics Begins De Novo CanGaroo Clinical Study
    • Memic Innovative Surgery Raises $96 Million
    • FDA Grants De Novo Clearance to Medtronic’s GI Genius Model
    • FDA OKs Baxter's AK 98 Hemodialysis Machine
    • Memic Receives FDA Marketing Authorization for Hominis
    PR Newswire01.03.19
    Bruin Biometrics, LLC ("BBI") has been granted U.S. Food and Drug Administration (FDA) marketing authorization for the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who are at increased risk for pressure ulcers.
     
    The SEM Scanner is the world's first FDA-authorized device to objectively alert clinicians to specific anatomical areas of a patient's body at increased risk for developing pressure damage. Patient risk assessments are performed with the SEM Scanner before visible damage manifests at the skin surface—a world and clinical first.
     
    Current clinical decision making relies on assessing a patient's overall risk for pressure ulcer development and then completing a subjective skin and tissue assessment. Both methods suffer from not being able to direct clinicians to where the risk is building until damage is visible at the skin's surface. Once pressure injuries (also known as pressure ulcers, or bed sores) become visible on the skin's surface, tissue damage has already occurred2.
     
    Elevated readings from the SEM Scanner provide objective clinical information that directs clinicians to heels and sacrums at risk of developing pressure ulcers, even before the damage is visible. These data can facilitate earlier, anatomically specific interventions designed to reverse the damaging effects of pressure and shear and prevent the pressure injuries from breaking through the skin.
     
    Still the number one most reported patient safety harm in many U.S. states, pressure ulcer incidence has remained stubbornly persistent3. More than 2.5 million people annually develop bed sores in the United States, including nearly one out of 10 patients in hospitals and almost one-third of patients in long-term acute care4.
     
    Bed sores can lead to pain, disfigurement, infection, and complications such as sepsis, cellulitis, and MRSA. 60,000 Americans die each year4 from complications from pressure ulcers—an equivalent mortality rate to the opioid crisis5—at an annual cost of up to $11.6 billion to the U.S. health care system6. These injuries result from pressure and shear causing localized damage to the skin and underlying tissue, typically at areas of bony prominence, such as the heels and sacrum.
     
    Outside the United States, clinicians have been using the SEM Scanner in conjunction with existing risk assessment tools since 2014. U.K. NHS and private providers have enjoyed and won numerous awards for innovation and patient safety, including the Health Service Journal's Patient Safety Award for Innovation (2017)7 and the Journal of Wound Care's Most Innovative Product (2018)8 for their use of the SEM Scanner.
     
    Valuable Advance Notice
    FDA granted marketing authorization for the SEM Scanner under its de novo review process for novel low- to moderate-risk devices that are not substantially equivalent to an already legally marketed device. 
     
    FDA authorization was based, in part, on data from a clinical study assessing performance of the SEM Scanner compared to visual skin assessment by nurses in 182 patients at risk for pressure ulcers at 12 hospitals and skilled nursing facilities in the U.S. and United Kingdom9.

    The SEM Scanner received European CE mark approval in 2014 and Health Canada clearance in 2016 and is in full commercial use in Canada and the European Union.
     
    No adverse or serious adverse events have occurred from SEM Scanner use.
     
    "Having anatomically specific risk information gives nurses valuable advance notice to institute additional preventive treatment tailored to a patient's unique needs," said Dr. Ruth Bryant, a SEM Scanner study investigator, author of "Acute & Chronic Wounds" (2016), certified wound ostomy continence nurse, director of nursing research at Abbott Northwestern Hospital in Minneapolis and president-elect of the Association for the Advancement of Wound Care.
     
    "The anatomically specific information combined with tailored preventive actions may ultimately translate into fewer pressure sores, decreased costs, increased quality of patient care, increased patient satisfaction and decreased risk for adverse events due to pressure ulcers such as in-hospital mortality, prolonged length of stay, discharge to an extended care facility rather than to the home, and infection," Dr. Bryant added.
     
    Dr. Barbara Bates-Jensen, a professor at the UCLA School of Nursing and the David Geffen School of Medicine and a co-inventor of the SEM Scanner, said: "Objective, scientific data from the SEM Scanner can give clinicians confidence to take action and intervene with methods to prevent pressure ulcers."
     
    Representative Ted W. Lieu (D-CA), representing the Los Angeles district where BBI is based, stated: "With the SEM Scanner, nurses have a new tool to risk assess patients for injuries that disproportionately impact the elderly, disabled veterans and others with limited mobility."
     
    BBI CEO Martin Burns welcomed FDA's decision: "Our singular objective is to reduce pressure injury incidence by helping clinicians make prevention real. Total prevention of avoidable pressure injuries is mathematically impossible under the current standard of care. Prevention success demands objective, early, anatomically specific data. For the first time, clinicians will have access to anatomically specific risk assessment data that can be gathered from increased risk patients in all care settings. We are optimistic about the impact these data will have on prevention strategies here in the U.S.A. With this FDA decision, wound prevention has finally caught up with other areas of healthcare that have long benefited from medical technologies."
     
    Burns continued, "We have very carefully recruited talented and experienced sales leaders, implementation and education professionals for the U.S. market. Approximately 20 U.S. and EU professionals are scheduled to attend formal office and field-based training in the U.K. in mid-January 2019."
     
    References
    1 Glenn Smith R.N., Clinical Nurse Specialist Nutrition and Tissue Viability at Isle of Wight NHS Trust, St. Mary's Hospital, Isle of Wight
    2 Oomens CW1, Bader DL, Loerakker S, Baaijens F. (2015) Pressure induced deep tissue injury explained. Ann Biomed Eng.Feb;43(2):297-305. doi: 10.1007/s10439-014-1202-6. Epub 2014 Dec 6.
    3 Padula, W., et al (2018) Value of hospital resources for effective pressure injury prevention: a cost-effectiveness analysis. BMJ Qual Saf. 0:1-10 doi:10.1136/bmjqs-2017-007505
    4 Preventing Pressure Ulcers in Hospitals. (2014, October 02). Retrieved from https://www.ahrq.gov/professionals/systems/hospital/pressureulcertoolkit/index.html 
    5 https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates  
    6 Russo CA, Steiner C, Spector W. Hospitalizations Related to Pressure Ulcers among Adults 18 Years and Older, 2006. Healthcare Cost and Utilization Project (HCUP. Rockville, MD: Agency for Healthcare Research and Quality, 2008. 
    7 https://awards.patientsafetycongress.co.uk/patient-safety-awards-winners-2017-1  
    8 https://www.jwcawards.com/winners  
    9 Evaluation of a Novel Device Using Capacitance of the Detection of Early Pressure Ulcers (PU), a Multi-Site Longitudinal Study.  Okonkwo H. Milne et al. (2018). Accepted and presented at NPUAP 2018. Retrieved from https://epostersonline.com/wounds2017/node/814
    Related Searches
    • ucla
    • ce mark
    • health
    • president-elect
    Related Knowledge Center
    • Patient Monitoring
    Suggested For You
    Aziyo Biologics Begins De Novo CanGaroo Clinical Study Aziyo Biologics Begins De Novo CanGaroo Clinical Study
    Memic Innovative Surgery Raises $96 Million Memic Innovative Surgery Raises $96 Million
    FDA Grants De Novo Clearance to Medtronic’s GI Genius Model FDA Grants De Novo Clearance to Medtronic’s GI Genius Model
    FDA OKs Baxter FDA OKs Baxter's AK 98 Hemodialysis Machine
    Memic Receives FDA Marketing Authorization for Hominis Memic Receives FDA Marketing Authorization for Hominis
    FDA Breakthrough Device Designation Awarded to BrainCool AB FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval
    Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes
    Global Central Venous Catheter Market to Surpass $3.06 Billion by 2027 Global Central Venous Catheter Market to Surpass $3.06 Billion by 2027
    FDA Grants Breakthrough Device Designation to Cala Trio FDA Grants Breakthrough Device Designation to Cala Trio
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    FDA OKs SentiAR FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter

    Related Breaking News

    • Aziyo Biologics Begins De Novo CanGaroo Clinical Study

      Aziyo Biologics Begins De Novo CanGaroo Clinical Study

      Trial aims to provide insights into the profiles of patients selected for CanGaroo Envelope implantation.
      Globe Newswire 06.29.21

    • Memic Innovative Surgery Raises $96 Million

      Memic Innovative Surgery Raises $96 Million

      Funding will primarily support commercialization of the Hominis surgical robot in the United States.
      Michael Barbella, Managing Editor 06.01.21

    • Diagnostics
      FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

      FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

      Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.
      Charles Sternberg, Assistant Editor 04.15.21


    • Chronic Disease
      FDA OKs Baxter

      FDA OKs Baxter's AK 98 Hemodialysis Machine

      Can be used alongside Theranova, Baxter’s novel dialysis membrane.
      Sam Brusco, Associate Editor 03.15.21

    • Surgical
      Memic Receives FDA Marketing Authorization for Hominis

      Memic Receives FDA Marketing Authorization for Hominis

      Its robot-assisted surgical platform is now available for use in transvaginal gynecologic procedures including benign hysterectomy.
      Charles Sternberg, Assistant Editor 03.02.21

    Loading, Please Wait..

    Trending
    • The Future Of Biomedical Engineering Advancements
    • Cirtec Medical Corporation Acquires Precision Components Business From QMD
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • Coloplast Launches New Catheter In The U.S.
    • A New Approach To Post-Market Surveillance
    Breaking News
    • The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
    • Coloplast Launches New Catheter in the U.S.
    • Josh Ghaim and Sachin Jain Join Cue Health Board of Directors
    • NAMSA Relaunches Medtech Outsourcing Solution
    • Rollomatic Inc. Welcomes Joe Kane as CEO
    View Breaking News >
    CURRENT ISSUE

    November 2022

    • MPO's 2022 Year in Review
    • Fine Print: A Discourse on Additive Manufacturing
    • Grab and Go: Examining the Thrombectomy Device Market
    • 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

    BAPP Paper Reviews Common Adulteration Practices Which Go Undetected
    CRN Announces Promotions and Welcomes New Staff Member
    Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study
    Coatings World

    Latest Breaking News From Coatings World

    PPG Achieves ISO 14001 Certification of Environmental Management System
    AmCoat’s Rhino Shield and Floor Shield Break Records in 2022
    Automotive Industry Leaders Form Cofinity-X JV
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
    Coloplast Launches New Catheter in the U.S.
    Josh Ghaim and Sachin Jain Join Cue Health Board of Directors
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Jones Healthcare Group Installs BOBST NOVACUT 106 ER Flatbed Die-Cutter
    Pfizer Revenues Soar to Record-Breaking $100B in 2022
    iuvo BioScience Appoints Industry Exec to Lead Lab Biz
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Pacifica is our Packager of the Year
    La Roche-Posay Named the Fastest Growing Skincare Brand of 2022 by NielsenIQ
    Disney Collaborates with Nailtopia on Limited-Edition Nail Collection
    Happi

    Latest Breaking News From Happi

    Color Street Launches ‘Through the Cosmos’ Collection
    Curl Care Collection is New at Native
    Color Street Pledges $100K To Support Military & Veteran Appreciation
    Ink World

    Latest Breaking News From Ink World

    International Paper Reports Full-Year, 4Q 2022 Results
    UFlex Exhibits Sustainable Printing, Packaging Solutions at Plast India 2023
    Early-Bird Registration Opens for Print UV 2023
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    SABIC announces value chain partnerships
    Digital Embellishment Alliance launches new website community
    FLAG achieves record membership in 2022
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Superior Felt & Filtration Adds Domestic Injection Molding to its Medical Filtration Capabilities
    Ahlstrom Launches New Generation FluoroFree Technology
    Berry to Begin Production at India Healthcare Hub Early This Year
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Mobi-C Cervical Disc Replacement Procedures Top 200,000
    OPUM, Corflex Global Partner on Knee Assessment Technology
    ODT's Most-Read Stories This Week—Jan. 28
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Johan Hjertonsson Proposed as New Chairman of ASSA ABLOY
    Durak Highlights SilverPro Conductive Threads
    Arkema Partners with Research Institute to Open Lab in Mulhouse, France

    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