1. Articles from mpo-mag.com

  2. 1-26 of 26
    1. VoCare Develops Mobile Professional Grade Medical Multi-Diagnostic Device - Your online source for medical device product information - Medical Product Outsourcing

      VoCare Develops Mobile Professional Grade Medical Multi-Diagnostic Device - Your online source for medical device product information - Medical Product Outsourcing

      VoCare Inc. has developed the world's first professional grade medical diagnostic device which collects six different health vitals and is equipped with WiFi, Bluetooth, 4G LTE for data transmission, without the need for separate peripherals or an external hub.

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      Mentions: Jorg Lorscheider
    2. Cook Medical’s Cellvizio Receives Further 510(k) Clearance

      Cook Medical’s Cellvizio Receives Further 510(k) Clearance

      Cook Medical’s Cellvizio Confocal Laser Endomicroscopy (CLE) System and the Confocal Miniprobes have received additional 510(k) clearance from the U.S. Food and Drug Administration (FDA). Additional data provided in multiple peer-reviewed medical journals paved the way for this new clearance and indication for the Cellvizio system.

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    3. AngioDynamics Receives FDA Expedited Access Pathway Designation For The NanoKnife System

      AngioDynamics Receives FDA Expedited Access Pathway Designation For The NanoKnife System

      AngioDynamics Inc., a provider of minimally invasive medical devices for vascular access, peripheral vascular disease, surgery, and oncology, announced that the U.S. Food and Drug Administration (FDA) has granted the Expedited Access Pathway (EAP) designation to the company’s NanoKnife System and proposed indication for use for the treatment of Stage III pancreatic cancer.

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    4. A Holistic Approach To Software Outsourcing

      A Holistic Approach To Software Outsourcing

      The days of basic, minimally functional devices being accepted in the medtech market are long gone. Like it or not, today’s users expect their medical devices to be like their iPhones or tablet computers. Screen buttons should animate when pressed, lists should scroll gracefully, and graphics should be attractive. Also, usability engineering is no longer an option. Human-computer interaction must now be considered, incorporated into the product design, and blessed by the U.S, Food and Drug Administration (FDA). A well-designed user interface/user experience (UI/UX) is essential for increasing safety and reducing errors.

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    5. Zero-Defect Manufacturing: Paramit Comes Close (with Video) - Your online source for medical device product information - Medical Product Outsourcing

      Paramit Corporation

      Zero-defect manufacturing. Is that even possible? Paramit Corporation claims it is. Well, they are as close to zero-defect as possible for a medical device manufacturer.

      The Morgan Hill, Calif.-based company reports that it is able to achieve this manufacturing quality from its long-time focus on assembling printed circuit board assemblies (PCBAs) at Six Sigma quality levels, combined with its patent-pending vPoke system that enables defect-free mechanical assembly. The vPoke system is meant to simplify the mechanical assembly and testing of a complex product into hundreds or thousands of steps using sophisticated computer systems to validate and verify each step.

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    1-26 of 26
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