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 Amanda Maxwell 27 Nov 2019
There may have been a significant increase in the amount of regulatory activity at EU level of late, but the medtech industry remains alarmed at the lack of readiness of the system, and calls for an urgent focus on IVDs now too.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By ferdous-al-faruque 27 Nov 2019
As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 20 Nov 2019
A newly approved contact lens from CooperVision promises to slow the progression of nearsightedness when prescribed to children aged 8 to 12.
Topic FDA
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Marion Webb 20 Nov 2019
Sweden's Recipharm has agreed to buy UK-based Consort Medical for £505m ($652m) to become a leading inhalation-device company and top five global CDMO.
Topic deal-trends
Medtech Insight: 世界の医療機器・医療技術の最新情報
13 Nov 2019
US Democratic Sens. Elizabeth Warren of Massachusetts and Patty Murray of Washington State recently sent a letter to FDA officials Brett Giroir and Jeff Shuren that raises doubts about a planned bill calling for a progressive approval pathway for medical devices.
Topic FDA Policy and regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
13 Nov 2019
While a government agency shutdown due to lack of agreement between Congress and the Trump administration over funding for the US Food and Drug Administration and other federal agencies seems less likely this year than last, the FDA will still have carry out its 2020 mission in the short term on 2019 continuing resolution funding – probably through December – legislative experts say.
Topic fda policy-and-regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
08 Nov 2019
With a new CEO at its helm, Laboratory for Advanced Medicine is preparing to take on the cancer-diagnostics market. Former AncestryDNA executive Kenneth Chahine has joined the company as it plans to drive global commercialization of its artificial intelligence liquid biopsy pipeline.
Topic cancer company-analysis
Medtech Insight: 世界の医療機器・医療技術の最新情報
By ferdous-al-faruque 08 Nov 2019
Medtronic’s director of quality sterilization and microbiology, Phil Cogdill, sat down with Medtech Insight to talk about setting new ethylene oxide (EtO) standards and what his takeaways were from the first day of a US FDA meeting to understand how to mitigate potential product shortages from closures of EtO sterilization facilities. Check out our podcast here.
Topic fda
Medtech Insight: 世界の医療機器・医療技術の最新情報
01 Nov 2019
Already used by tens of millions of consumers, voice assistants such as Amazon's Alexa are increasingly making their way into hospitals and health organizations. This article outlines multiple use cases where voice is deployed in health systems today, while offering expert insights on trends, opportunities and challenges in this growing space.
Topic Medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
31 Oct 2019
Watch this Informa Pharma Intelligence webinar recording for insights into the revolution of digital health including the latest trends, current and future opportunities, and regulatory efforts and risks. Experts from the medical devices and pharmaceuticals industries present crucial information about the continuing evolution of today’s digital health landscape.
Topic medtech digital-health
Medtech Insight: 世界の医療機器・医療技術の最新情報
25 Oct 2019
Stay aware of key developments and trends in US Medicare and understand their impact on the medtech industry with Medtech Insight. This article pack contains the latest US Medicare updates and late-stage developments.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
25 Oct 2019
Don’t miss a beat with updated coverage of what’s happening with medtech and the US CMS with this article pack. Medtech Insight delivers vital, current news and insights.
Topic Medtech Policy and regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
07 Oct 2019
On the heels of the July 2019 US presidential executive order to advance kidney health, companies like Paragonix have unveiled new technologies aimed at doing just that. Medtech Insight takes you inside what the company has in store.
Topic Medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
07 Oct 2019
Since a presidential executive order to advance kidney health was signed in July of 2019, Medtech Insight has been tracking the subsequent developments in US kidney healthcare, noting an uptick in hemodialysis interest and new payment models around renal disease.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
23 Aug 2019
US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.
Topic policy-and-regulation
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