MedInsight

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  • Emerging Solutions to Address The Environmental Impact of Pregnancy Tests

    Emerging Solutions to Address The Environmental Impact of Pregnancy Tests

    Disposable digital pregnancy tests add to the plastic waste crisis through e-waste, non-recyclable materials, and toxic batteries. Emerging sustainable options like reusable and biodegradable tests offer greener, eco-friendly alternatives to reduce this environmental impact.
  • The IVDR extension amendment bill was officially published in the EU Official Journal

    The IVDR extension amendment bill was officially published in the EU Official Journal

    The IVDR transition period has been extended, allowing importers to continue selling products certified under the previous IVDD directive. This extension provides more time to comply with labeling, documentation, and certification requirements, minimizing non-compliance risks and maintaining market access.

  • Technological Innovation in the Medical Device Industry: A 2024 Overview

    Technological Innovation in the Medical Device Industry: A 2024 Overview

    Discover how AI, wearables, and cutting-edge diagnostics are driving innovation in the medical device industry in 2024, reshaping healthcare delivery while navigating regulatory and cybersecurity challenges.
  • EU releases Q&A document on IVDR transition period extension and MDR transition period extension Q&A document update

    EU releases Q&A document on IVDR transition period extension and MDR transition period extension Q&A document update

    The European Commission has released a Q&A document regarding the extension of the IVDR transition period, as well as an updated Q&A document on the extension of the MDR transition period, pursuant to Regulation 2024/1860, which was recently published.
  • The application value of AI technology to family diagnosis

    The application value of AI technology to family diagnosis

    The application value of AI technology in family diagnosis is great, making diagnosis more accurate, convenient and efficient. By providing personalized health management solutions and empowering users with more health knowledge, AI is changing the way individuals approach health, leading to better health outcomes and more efficient healthcare systems.
  • FDA and EU expand Mutual Recognition Agreement, again!

    FDA and EU expand Mutual Recognition Agreement, again!

    In 2017, the FDA initiated MRAs with EU and UK, for human drugs. On May 30th, the FDA once again signed an MRA, with 16 EU countries, this time concerning veterinary drugs.
  • Keeping Tabs on Your Kidneys: The Importance of Using a Renal Function Meter

    Keeping Tabs on Your Kidneys: The Importance of Using a Renal Function Meter

    Discovering the significance of maintaining optimal kidney health is crucial for overall well-being. And now, keeping tabs on your kidneys has never been easier with the introduction of the Renal Function Meter. 
  • Reusable Pregnancy Tests Changing the Landscape

    Reusable Pregnancy Tests Changing the Landscape

    Enter the eco-friendly solution: reusable pregnancy tests. These sustainable, innovative devices are not only shaping the way we test for pregnancy but are also harmonizing with the increasing global emphasis on environmental consciousness.
  • Home Healthcare with Hemoglobin Meters

    Home Healthcare with Hemoglobin Meters

    Before exploring their practical uses, it's essential to grasp the fundamental concept of hemoglobin meters.Hemoglobin meters are compact medical instruments meticulously engineered for gauging the hemoglobin concentration in an individual's blood.
  • Promising Outlook: Portable Hemoglobin Meter Market

    Promising Outlook: Portable Hemoglobin Meter Market

    Before delving into the portable hemoglobin meter market, it's important to understand the significance of hemoglobin in healthcare.
  • European Cholesterol Testing Landscape

    European Cholesterol Testing Landscape

    Low-density lipoprotein (LDL), commonly referred to as "bad" cholesterol, is recognized for its role in heightening the vulnerability to heart disease and strokes.
  • Cholesterol Testing Market Analysis

    Cholesterol Testing Market Analysis

    The global cholesterol testing products market achieved a substantial milestone, surging to a value of US$ 8.5 billion in 2022. Anticipating a trajectory of remarkable expansion, the market is poised to ascend to even greater heights, potentially reaching a staggering US$ 15.9 billion by the year 2030.
  • Easier Parenthood: Wee-Enhanced Digital Pregnancy Tests

    Easier Parenthood: Wee-Enhanced Digital Pregnancy Tests

    Embarking on the journey of parenthood is an exhilarating and life-altering experience, filled with anticipation, wonder, and a touch of nervousness. Enter the digital pregnancy test with weeks estimator, an innovation designed to offer expectant parents peace of mind during this pivotal time. 
  • Impact of European AI Act on Medical Devices

    Impact of European AI Act on Medical Devices

    EU AI Act is to be the world's first AI law. European Parliament passed the draft on June 14. However, it faced opposition from industry organizations like MedTech Europe, the Confederation of European Business, and Team-NB (European Association for Medical Devices Notified Bodies).
  • Decoding QMSR: FDA QMSR & ISO 13485 Harmony

    Decoding QMSR: FDA QMSR & ISO 13485 Harmony

    QMSR will align FDA's medical device quality management system with ISO 13485:2016. It will be released by the end of this year and become effective one year later. This harmonization is expected to save medical device companies at least $439 million over the next decade.
  • Advantages: Digital Pregnancy Tests with Weeks Indicator

    Advantages: Digital Pregnancy Tests with Weeks Indicator

    Embracing digital innovation, these tests eliminate the guesswork and provide specific information, empowering you with the knowledge you need as you embark on this incredible journey. 
  • Design Patent vs Utility Patent: the Right One for Your Product - Hangzhou MedAsia

    Design vs Utility Patent: Your Product Choice

    The BP pressure cuffs, stethoscopes, thermometers, and more has been around for a long time and is not protected. No difference between you and competitors.
    Don't panic. Use Design Patents to separate yourself from them!
  • EU MDR transition period extended to 12/2028 - Hangzhou MedAsia

    EU MDR Transition Extended to 12/2028

    With Medasia, you can confidently bring safe and effective medical devices to market while staying up to date with the latest MDR guidelines. Don't risk non-compliance – secure your MDR certification today with Medasia's future-proof homecare products.
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