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    Breaking News

    FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector

    With the 510(k) clearance, practitioners can leverage dual-energy at the bed side for the first time.

    FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector
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    • Spineology Announces FDA Grant of Interbody Fusion System
    KA Imaging09.08.20
    KA Imaging’s portable dual-energy X-ray detector has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Reveal enables bone and soft-tissue differentiation without motion artifacts in a single X-ray exposure. In other words, with one shot, the detector simultaneously delivers DR, bone, and tissue images.

    “We are excited to announce the clearance of Reveal, after years of dedicated work, and we will strive to apply this technology directly to help patients and medical personnel through these trying times,” said Amol Karnick, president and CEO of KA Imaging.

    The different applications for this technology include providing radiologists with unobstructed views of the lungs, which can aid in the visualization of pneumonia, fractures, catheters, and masses with high sensitivity. “The soft tissue and bone images are sharp and free of motion artifacts which increases the diagnostic sensitivity,” said Dr. Karim S. Karim, CTO of KA Imaging.

    Reveal is also portable, and can be taken to the bedside of patients, which is critical during these pandemic times.

    Whereas fixed dual-energy systems can cost as high as half a million dollars, KA Imaging’s Reveal is highly affordable at less than 1/4 of this price.

    “Any hospital can now benefit immediately from higher sensitivity X-ray imaging by simply adding dual energy capability to any installed fixed or portable X-ray machines,” said Karnick.

    A new clinical trial began this week in Toronto to seek early and reliable detection of pneumonia (including COVID-19).

    “Early triaging is an essential countermeasure to prevent the spread of COVID-19 infection, and we are confident that our technology can make a significant contribution,” said Karim.

    Reveal is also being tested on patients with lung cancer at Grand River Hospital in Kitchener, with promising results.
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    First 3D Printed HAnano Surface Modified Implant Gets FDA Approval First 3D Printed HAnano Surface Modified Implant Gets FDA Approval
    MCRA Hires Former FDA Associate Director to Expand Neurology Franchise MCRA Hires Former FDA Associate Director to Expand Neurology Franchise
    IlluminOss Earns FDA Nod for Use in Fibula Fractures IlluminOss Earns FDA Nod for Use in Fibula Fractures
    Safe Orthopaedics Receives FDA 510(k) Approval for Second Generation of SteriSpine PS Safe Orthopaedics Receives FDA 510(k) Approval for Second Generation of SteriSpine PS
    FDA OKs Life Spine FDA OKs Life Spine's PLATEAU-A Ti Anterior Lumbar Spacer System
    Medacta NextAR Platform Cleared by FDA Medacta NextAR Platform Cleared by FDA
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    Related Breaking News

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      Charles Sternberg, Assistant Editor 03.04.21

    • Full-Year Sales Down 12 Percent at Zimmer Biomet

      Full-Year Sales Down 12 Percent at Zimmer Biomet

      Coronavirus prompts deficits in all product categories and geographic regions.
      Michael Barbella, Managing Editor 03.04.21

    • Lincotek Medical Expands Coatings and Additive Capacity

      Lincotek Medical Expands Coatings and Additive Capacity

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    • Spine/Neurology
      Spinal Elements Relaunches the Luna XD and Orbit Systems

      Spinal Elements Relaunches the Luna XD and Orbit Systems

      The first minimally-invasive TLIF with new Spinal Elements products was also performed.
      Sam Brusco, Associate Editor 03.03.21

    • Coronavirus Triggers Double-Digit Revenue Dropoff at Smith+Nephew

      Coronavirus Triggers Double-Digit Revenue Dropoff at Smith+Nephew

      Total 2020 proceeds and operating profit tumble as COVID-19 impacts elective procedures.
      Michael Barbella, Managing Editor 03.03.21

    • Extremities
      FDA Approves Accufix Surgical

      FDA Approves Accufix Surgical's Accu-Joint Hemi Implant

      Hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal (MTP) joint.
      Sam Brusco, Associate Editor 03.02.21


    • Trauma/Sports
      FDA OKs Q-Collar Device to Protect Athletes’ Brains During Head Impacts

      FDA OKs Q-Collar Device to Protect Athletes’ Brains During Head Impacts

      C-shaped collar applies compressive force to the neck and increases blood volume.
      Sam Brusco, Associate Editor 03.02.21

    • Spine/Neurology
      SeaSpine Releases Reef TO (TLIF Oblique) Interbody System

      SeaSpine Releases Reef TO (TLIF Oblique) Interbody System

      Accommodates both direct impact insertion and insert-and-rotate techniques.
      Sam Brusco, Associate Editor 03.02.21

    • Align Technology Inc. Executive Joins Zimmer Biomet Board

      Align Technology Inc. Executive Joins Zimmer Biomet Board

      CEO Bryan Hanson to replace retiring board chairman in May.
      Michael Barbella, Managing Editor 03.02.21


    • Pandemic Pain: NuVasive

      Pandemic Pain: NuVasive's 2020 Sales Fall 10 Percent

      Diluted EPS is cut in half as the company contends with COVID-19's impact.
      Michael Barbella, Managing Editor 03.01.21

    • Spine/Neurology
      Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System

      Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System

      The product offers clinicians greater procedural efficiency.
      Michael Barbella, Managing Editor 02.26.21

    • Kaia Health Unveils Next-Gen Complete MSK Care Solutions

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      Kaia Gateway and Premium Partners help achieve better outcomes while saving money for employers.
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    • Spine/Neurology
      First Implantation of CTL Amedica

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      The product is designed to enable the surgeon to navigate MIS lumbar procedures more freely.
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    • Spine/Neurology
      NuVasive Nabs Simplify Medical for $150M

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      The firm obtains the Simplify Cervical Artificial Disc for cervical total disc replacement.
      Sam Brusco, Associate Editor 02.24.21

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      SeaSpine Begins Limited Launch of WaveForm TA (TLIF Articulating) 3D-Printed Interbody

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    Trending
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    Breaking News
    • Bioventus Appoints Managing Director, China and Asia Pacific
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    CURRENT ISSUE

    January/February 2021

    • Instrumentation Innovations: A Review of Instrument Manufacturing
    • The Total Package: Packaging and Sterilization for Orthopedics
    • Helping Nature Take Its Course: A Biologics Breakdown
    • View More >

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