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    FDA clears iRhythm’s ZEUS system for Zio Watch

    iRhythm Technologies (Nasdaq:IRTC) announced that it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system. ZEUS, produced in partnership with Google’s life sciences...

    Nyxoah Announces CE Mark Approval for Genio® 2.1

    Nyxoah Announces CE Mark Approval for Genio® 2.1 The next generation external activation chip leverages Nyxoah’s scalable platform to continuously enhance patient comfort and therapy...

    Waypoint Orthopedics seeks FDA 510(k) approval for smart bone awl

    The system provides visual feedback regarding the location of the probe and reduces radiation exposure during surgery. Spinal instrumentation firm Waypoint Orthopedics has submitted an application seeking...

    DyAnsys receives US FDA approval for First Relief neurostimulation device

    First Relief is placed behind the ear and provides continuous pulses of low-level electrical current. DyAnsys has received US Food and Drug Administration (FDA) approval for its...

    FDA clears Healthy.io’s smartphone-based AI test for early-stage kidney disease

    At-home diagnostics have been a crucial weapon in the war against the COVID-19 pandemic, and after proving their mettle on that battlefield, they’re now...

    Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System

    Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, announced that the U.S. Food and Drug Administration (FDA) has...

    Stereotaxis Announces CE Mark Submission for Robotically Navigated MAGiC Catheter

    Stereotaxis has announced the CE Mark submission for its MAGiC™ catheter. The MAGiC catheter is a robotically navigated magnetic interventional ablation catheter for minimally invasive...

    Nyxoah receives FDA approval to begin Genio system trial

    The trial will assess the use of the Genio system to treat moderate to severe OSA and CCC in adult patients. Medical technology firm Nyxoah...

    Renovia receives FDA clearance for leva® Pelvic Health System as first-line treatment for chronic fecal incontinence

    Renovia Inc. ("Renovia"), a developer of non-surgical, treatments for female pelvic floor disorders and an advocate for women's health, announced that the U.S....

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