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世界の医療機器・医療技術に関する最新情報

Medtech Insight(メドテックインサイト)では、世界の医療機器・医療技術に関する最新の開発状況(臨床試験の結果、承認審査、市販後の更新情報等)や投資動向、ディール活動、参入企業の動きなど医療機器・医療技術産業全体の最新情報をお伝えします。

欧州、米国、アジアの各地に拠点を置く経験豊富なジャーナリスト&アナリストが、独自の分析と業界のオピニオンリーダーの考えを交えてニュースをお伝えします。FDAの警告書をモニターするMedtech Insight trackerにもアクセスできます。

下記のようなニーズにお応えします

  • 世界中の医療機器・医療技術の動きをフォローしたい
  • 競合企業の動きをチェックしたい
  • ライセンス導入/導出、投資、提携、M&Aの機会を探したい
  • 医療機器・医療技術のグローバルな薬事規制や承認審査の最新情報を常に把握したい

 

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このサービスの特徴

無料の最新記事&レポート

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    EU Regulatory Roundup November 2018

    05 Dec 2018

    The medtech sector was already quite overwhelmed with the new EU regulations and Brexit uncertainties. Now add into the mix the impact of the global journalistic Implant Files investigation.

    Topic Brexit Medtech

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

    By elizabeth-orr 05 Dec 2018

    A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.

    Topic fda

  • Scrip: 世界の医療用医薬品&製薬産業に関するニュース, Pink Sheet: 世界の薬事規制と承認審査に関するニ...

    医療用医薬品、医療機器、薬事規制ニュース配信サービス

    09 Nov 2018

    Pharma Intelligence offers a wealth of pharmaceutical industry news and strategic insight into the healthcare & biotechnology markets from around the world. Working in an interconnected global network, our 65 journalists and over 300 in-house analysts supply comprehensive analysis and reports.

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Commissioner Says EU MDR/IVDR Implementation 'On Track,' But Fails To Convince Parliament

    31 Oct 2018

    Elżbieta Bieńkowska, a European Commissioner,  is "realistic and confident" when it comes to the implementation of the new EU medtech regulations. She says everything is going to plan. But that is not what members of the European Parliament are hearing.

    Topic medtech

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Embrace The Digital Revolution, But On Your Own Terms, John Nosta Says

    31 Oct 2018

    Digital health and innovation strategist John Nosta talks about the need for medical technology companies to stay true to their technology roots and not get too attached to the "patient centricity" bandwagon. Also: innovating organically and "failing smart."

  • Meddevicetracker: 医療機器の市場調査分析, Medtech Insight: 世界の医療機器・医療技術...

    Neuromodulation Device Market Innovations and Trends Webinar

    By David Filmore 29 Oct 2018

    Join our presenters as they explore the area of neuromodulation, which is seeing significant growth at a time when other medical device markets are facing declining growth. The team focus on three targeted neuromodulation areas, including: spinal cord stimulation (SCS), deep brain stimulation (DBS) and vagus nerve stimulation (VNS).

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Drug/Software Combo Pathway Coming Soon To US FDA, Gottlieb Says

    26 Oct 2018

    Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.

    Topic Digital Health

  • Medtech Insight: 世界の医療機器・医療技術の最新情報

    Philippines Gets Moving On Reg Reform: Asian Medtech Associations Regulatory Networking, October 2018

    26 Oct 2018

    The Asian Medtech Associations Regulatory Networking discussions this month focus on regulatory reforms in the Philippines, where good progress is being made on embedding a new set of medical device, IVD and labeling regulations. Also, updates from Thailand, Hong Kong and India. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

    Topic FDA

  • Medtech Insight:世界の医療機器に特化したニュース配信

    Proposed 510(k) Changes Elicit Some Industry Skepticism

    By elizabeth-orr 18 Oct 2018

    Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

    Topic fda

  • Medtech Insight:世界の医療機器に特化したニュース配信

    US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling

    18 Oct 2018

    A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.

    Topic medtech

  • Medtech Insight:世界の医療機器に特化したニュース配信

    Medtech Insight Awards 2018 Video

    12 Oct 2018

    The inaugural Medtech Insight Awards took place on September 23 in Philadelphia. It was an exciting evening of celebration, camaraderie and spirit, and the participation and enthusiasm of everyone present helped make the event a rousing success.

  • Medtech Insight:世界の医療機器に特化したニュース配信

    TCT 2018: Next-Gen Stents, Key Insights From Leading Experts

    By Marion Webb 26 Sep 2018

    The Transcatheter Cardiovascular Therapeutics meeting held in San Diego featured late-breaking trials of new stent technologiesincluding TALENT, BIONYX, BIOFLOW-V, SORT-OUT IX, LEADERS FREE II and ReCre8.

    Topic medtech

  • Medtech Insight:世界の医療機器に特化したニュース配信

    First EU Notified Body Designations Could Come Earlier Than Expected, But Caution Advised

    26 Sep 2018

    There's been progress toward designating notified bodies against the EU's medtech regulations, but the developments need to be scrutinized so that the sector preserves a sense of reality about capacity issues, MedTech Europe's Oliver Bisazza says.

    Topic Medtech

  • Medtech Insight:世界の医療機器に特化したニュース配信

    Payment 'Sunshine' Requirements Would Expand For Industry Under Senate-Passed Opioid Bill

    By Sue Darcey 20 Sep 2018

    A provision to expand Sunshine Act industry reporting requirements for companies in the Senate-passed “Opioid Crisis Response Act” has caught criticism from the device sector, despite overall industry support for the legislation.

    Topic drug-review

  • Medtech Insight:世界の医療機器に特化したニュース配信

    Start-Up Spotlight: Creavo Medical, Diagnosing Myocardial Ischaemia With MCG

    By Cathering Longworth 12 Sep 2018

    UK medtech company Creavo Medical is trying to bring its magnetocardiography (MCG) technology to emergency departments worldwide for speedier diagnosis of heart disease. Distinguishing between ischemic heart disease and non-cardiac chest pain remains a challenge in emergency departments. Currently, all patients presenting with chest pain are assessed with electrocardiography and blood tests to rule out heart disease, but almost three-quarters of patients with chest pain do not have a cardiac-related condition.

医薬品産業専門のジャーナリスト&アナリスト

Editor

Amanda Maxwell

Editor, Medtech Regulatory Affairs Editor
Amanda Maxwell

Amanda specializes in

  • Policy & Regulation
  • Medtech

+34 year(s) experience

Management

Richard Faint

Management, Head of Medtech
Richard Faint

Richard specializes in

  • Cardiovascular
  • CNS
  • Immunology & Inflammation
  • Infectious Diseases
  • Oncology

+27 year(s) experience

Analyst

Maureen Riordan

Analyst, Senior Deals Analyst
Maureen Riordan

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