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のページにアクセスすると、各記事の冒頭部分のみご覧になれます。お気軽に無料トライアルもお試しください。
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.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Brian Bossetta 03 Aug 2021
After much wrangling, the US agency finally clarified its position on what evidence can determine "intended use" of a product – and industry is not happy.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Barnaby Pickering 03 Aug 2021
The global market for robotically assisted surgical devices will reach $11.5bn by 2025 as system improvements drive sales.
Medtech Insight: 世界の医療機器・医療技術の最新情報
13 Jul 2021
Based on the results of a study with 234 smokers, the FDA cleared an updated indication for Carrot’s Pivot breath sensor, an over-the-counter carbon monoxide sensor that helps motivate people to stop smoking.
Medtech Insight: 世界の医療機器・医療技術の最新情報
13 Jul 2021
EU rapidly revises new guidance document on registration requirements under the new MDR and IVDR to address question of when importers need to register in Eudamed medical device database.
Medtech Insight: 世界の医療機器・医療技術の最新情報
22 Jun 2021
Onward has been granted three FDA breakthrough designations for ARC Therapy, a spinal cord stimulation therapy that aims to restore movement and improve quality of life of people with spinal cord injuries.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 22 Jun 2021
The exemptions allow for face masks, diagnostics and oxygen tanks, among others, to be shipped to Iran, Syria and Venezuela without specific permission.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Brian Bossetta 18 Jun 2021
Starting 1 July, Medicare beneficiaries with a certain type of cardiovascular disease will be able to receive an innovative treatment covered under their government plans.
Medtech Insight: 世界の医療機器・医療技術の最新情報
16 Jun 2021
With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 15 Jun 2021
The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.
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