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。
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Medtech Insight: 世界の医療機器・医療技術の最新情報
By ferdous-al-faruque 14 Jan 2022
The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.
Medtech Insight: 世界の医療機器・医療技術の最新情報
14 Jan 2022
Paige, an AI-for-digital-pathology company, and Acarix AB, developers of an acoustic cardiac diagnostic both have new chiefs.
Medtech Insight: 世界の医療機器・医療技術の最新情報
13 Jan 2022
The annual J.P. Morgan Healthcare Conference includes presentations from major medtech companies describing their experience in 2021 and expectations for 2022 as they continue to cope with the impact of the Omicron surge. Here are some of the highlights from the presentations on the fourth day of the meeting.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By ferdous-al-faruque 30 Nov 2021
The MITRE corporation and MDIC have produced a manual on how to use cybersecurity threat modeling to make safer medical devices. The document asks four basic questions and provides helpful examples.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Barnaby Pickering 30 Nov 2021
In an interview with Medtech Insight, Per Vegard Nerserth, CEO of CMR Surgical, discusses how the company adapted to the pandemic, its future plans, and how the competition for market dominance is shaping up.
Medtech Insight: 世界の医療機器・医療技術の最新情報
02 Nov 2021
The medtech sector’s drive to create a fairer health care system and a greener world will go on after the COVID pandemic, which has brought such issues into sharp relief. CEOs at leading companies discuss environmental, social and governance imperatives for their companies and the larger industry.
Medtech Insight: 世界の医療機器・医療技術の最新情報
02 Nov 2021
The once and likely future FDA commissioner emphasized the value of randomized controlled trials, the fact that not all trials are good for people, and how decentralization and digitization are leaving people behind during a panel discussion.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Marion Webb 12 Oct 2021
In this roundup of developments in digital health, we highlight the key news and announcements from August and September.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Barnaby Pickering 12 Oct 2021
In a panel discussion at The Medtech Conference, hosted by AdvaMed, CEOs discussed the challenges, benefits and technicalities surrounding an IPO.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By ferdous-al-faruque 14 Sep 2021
The US Medicare agency has proposed to withdraw a rule that would give temporary automatic coverage to breakthrough devices, stating the rule doesn’t meet its evidence threshold and could put patients at risk.
Medtech Insight: 世界の医療機器・医療技術の最新情報
14 Sep 2021
Gone are the days when notified bodies needed to promote themselves to gain business. Now industry is left struggling to find services ̶ and the EU regulatory outlook is becoming worrisome.
Medtech Insight: 世界の医療機器・医療技術の最新情報
26 Aug 2021
Baxter says customers complained of “multiple pumps within their fleets” encountering system errors after they made changes to their network configuration and server systems. It’s the second software-related setback for the device maker in recent weeks.
Medtech Insight: 世界の医療機器・医療技術の最新情報
20 Aug 2021
The Safety Scalpel N11 is a component of Cardinal Health’s Argyle UVC Insertion Tray, which was recalled because it didn’t include the scalpel’s instructions for use. The recall has been labeled high-risk class I by the US FDA.
Medtech Insight: 世界の医療機器・医療技術の最新情報
13 Aug 2021
There are just 4.5 months left until the new harmonized Eurasian Economic Union medtech system becomes mandatory, signifying major changes in regional market access. EAEU member Russia is meanwhile strengthening its post-market medtech controls.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 13 Aug 2021
Ensuring key standards are available for manufacturers to demonstrate compliance with the MDR and IVDR is one of the top priorities for the European Commission after the summer break.
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