• FDA_logo_high_quality_sq_200-1 FDA Grants Marketing Authorization for Gait Improvement Device
    Fran Kritz
    May 12, 2021
    The Food and Drug Administration recently granted marketing authorization to Helius Medical Inc. for a device designed for short-term treatment of gait deficit caused by symptoms of multiple sclerosis (MS). The device, called the Portable Neuromodulation Stimulator (PoNS) is intended to be used during physical therapy for patients 22 and older.
  • A doctor and surgeon discuss something displayed on a tablet. Survey: Hospital-Based Use of AI Is Reaching a ‘Tipping Point’
    Fran Kritz
    May 12, 2021
    Many more hospitals currently have an AI strategy compared to just two years, according to a recent survey.
  • A sampling of panels from Health First's digital HTM dashboard. Digital Dashboard Spurs Repair Time Renaissance for Health First HTM
    Brian Stallard
    May 12, 2021
    A 2021 Bright Idea: A team of professionals from Health First Health System in Melbourne, FL, and Sodexo HTM recently developed a clever strategy for boosting morale while reducing device repair times. All it took, they said, was a few screens in the right place.
  • A line of formally dressed people applaud. AAMI Announces 2020 Winners of BI&T Awards
    May 10, 2021
    AAMI is recognizing sterility assurance researchers, a cybersecurity expert, and a multidisciplinary team of biomedical engineers, IT professionals, clinicians, human factors engineers, and administrators for their outstanding contributions to AAMI’s peer-reviewed journal, BI&T., in 2020.
  • A woman receives radiation therapy. Her face is covered. Sharing Machine Learning Models for Radiation Treatment Planning
    Emily Patterson, PhD & Dominic Di Costanzo
    May 7, 2021
    Dr. Emily Patterson and PhD student Dominic Di Costanzo share their thoughts on a burgeoning use of machine learning-based algorithms in clinical care, radiation treatment planning, and how to best share these models.
  • Photo portraits of Jesse Ehrenfeld and Pat Baird Co-Chairs Named for New AAMI Standards Committee Focused on Artificial Intelligence
    May 5, 2021
    An AAMI committee created to develop risk management guidance for artificial intelligence and machine learning in medical devices has appointed two co-chairs to lead its work: Pofessor of anesthesiology Dr. Jesse Ehrenfeld, MD, MPH, and  Pat Baird, Head of Global Software Standards at Philips.
  • Researchers in lab coats gather around a work station. The Kilmer Fund Committee Awards its First Kilmer Research Grant
    Erin Clancy
    May 4, 2021
    The AAMI Foundation’s new Kilmer Fund has awarded its first research grant, in the amount of $9,500, to Project Wicked Stability. The group seeks to reduce the need for stability testing of common sterile barrier material systems.
  • A biomedical engineering technician sets up a medical device in a hospital room. BMET Apprenticeship Program Secures First Official Partner
    Chris Hayhurst
    Apr 30, 2021
    AAMI's new BMET Apprenticeship Program is off and running thanks to Jackson, TN-based ReNew Biomedical Services. ReNew signed on with AAMI in April to become its first official partner in the one-of-a-kind program, which combines online and classroom education with up to 6,000 hours of on-the-job learning time. Program partners hire apprentices directly, and provide them with training—and paid work experience—at their own facilities.
  • An N95 mask lies on a table. Respirators No Longer Need to Do Double Duty, FDA Says
    Jennifer Peters
    Apr 29, 2021
    The FDA has issued new guidance to healthcare personnel and facilities saying that medical facilities can stop decontaminating disposable respirators for reuse and can go back to pre-pandemic practices. During a recent webinar, FDA representatives called the practice "one of the most extreme measures of respirator conservation."
  • NursesAndVentilator_226315410_sq ISO 19223 Brings Much Needed Order to Lung Ventilator Terminology and Semantics
    Steven L. Dain
    Apr 28, 2021
    ISO 19223:2019 seeks to play a pivotal role in bringing much needed order to variations in ventilator terminology. Use of standardized vocabulary will go a long way to improving patient safety by facilitating the understanding of ventilator capabilities, expediting training for multiple ventilators, improving device usability, and reducing cognitive load among clinicians.
  • GI Genius highlights a potential colon problem with a green box. FDA Authorizes First AI Device to Detect Colon Cancer
    Fran Kritz
    Apr 28, 2021
    The US FDA has granted premarket authorization to Cosmo Pharmaceuticals N.V. for the GI Genius, the first device to use AI to help detect signs of colon cancer during a colonoscopy
  • Doctors look over x-ray results, an example of diagnostics imaging. Fujifilm Healthcare Finalizes Acquisition of Hitachi’s Imaging Business
    Randolph Fillmore
    Apr 28, 2021
    FujiFilm Corporation announced that the acquisition of Hitachi’s diagnostic imaging business for $1.6 billon has been completed. Fujifilm Healthcare will now begin operating as Fujifilm Group Company.
  • A white N95 mask lies on a table. FDA Recommends Transition Away from Processing Single-Use Respirators
    Randolph Fillmore
    Apr 28, 2021
    The US FDA and CDC agree that the supply of new respirators, including N95s and NIOSH-approved particulate filtering facepiece respirators (FFRs), is adequate and are recommending that healthcare providers transition away from decontaminating disposable respirators for reuse.
  • Photo portrait of Jennifer Benolken One on One: Jennifer Benolken
    Apr 27, 2021
    A Q&A with Jennifer Benolken, CPPL, MDM & Regulatory Specialist, Packaging Engineering, Tyvek Medical Packaging, at DuPont.
  • HTM-levels-guide-02 Updated HTM Levels Guide Adds Online Assessment Tool
    Apr 27, 2021
    AAMI’s new-and-improved HTM Levels guide is now available with an online assessment tool, enabling healthcare technology management (HTM) departments to measure themselves against a national benchmark of excellence.
  • Sterilization professionals in full PPE. Summer Sterilization Webinar Series Introduces Best Practices, New Ideas
    Apr 27, 2021
    AAMI is introducing a new summer webinar series focused on best practices and new knowledge regarding industrial sterilization. The series is uniquely suited to help professionals learn methodology from the cutting edge of sterility assurance.
  • People collaborating over video conference. Online Sterilization Standards Week Attracts Emerging Professionals, New Ideas
    Jennifer Peters
    Apr 22, 2021
    AAMI's Sterilization Standards Week was recently held online, offering a unique opportunity: The chance to welcome more new entrants to standards development activities in the conversation.
  • A robot designed for disinfecting surfaces using UV-C radiation Study: Robots Not Replacing Humans for Hospital Disinfecting—Yet
    Fran Kritz
    Apr 21, 2021
    A study published in the journal Antimicrobial Resistance & Infection Control found that while speculation abounds that disinfecting robots could supplant humans in hospitals, the technology still has a long way to go.
  • Wisps of gas rise from a surface. FDA Approves Chlorine Dioxide Gas for Medical Device Contract Sterilization
    Fran Kritz
    Apr 21, 2021
    The Food and Drug Administration (FDA) recently approved the use of chlorine dioxide gas for contract sterilization of medical devices. The approval was awarded to ClorDiSys Solutions, Inc, based in Branchburg, NJ.
  • FDA_logo_high_quality_sq_200-1 Behind the Scenes at the FDA: Biocompatibility Assessment Resource Center Aims to Smooth the Path to Market
    Martha Vockley
    Apr 21, 2021
    Nearly every medical device that the FDA reviews for premarket approval or clearance requires a biocompatibility assessment from product developers. That’s because devices that come into direct or indirect contact with the human body may contain component materials with the potential for an unacceptable adverse biological response.