Pharma Intelligenceはインフォーマ株式会社が運営するビジネスインテリジェンス事業部の医薬品部門です。
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。
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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 Sue Darcey 11 Apr 2019
US House Representatives Ron Kind, D-Wis., and Jackie Walorski, R-Ind., have introduced a permanent medical device tax-repeal bill, alongside 225 co-sponsors from both parties.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
By ferdous-al-faruque 11 Apr 2019
International regulators are interested in seeing how they too can apply the US FDA’s precertification program, which is currently in the pilot stage. In an exclusive interview with Medtech Insight, the agency’s top digital health officer, Bakul Patel, talks about global curiosity about the program that could allow companies to get certain medical software on the market based on trust. Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Bob Kronemyer 22 Mar 2019
Transcatheter aortic valve replacement (TAVR) is performed routinely using devices providing protection from stroke as standard of care. However, cerebral embolic protection devices currently available do not capture and remove emboli from all three vessels leading to the brain. The Emblok Embolic Protection System from Innovative Cardiovascular Solutions (ICS) has developed an embolic filter designed to protect all three cerebral vessels during TAVR and remove debris from the entire circulatory system.
Topic Medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
22 Mar 2019
US Senate Finance Committee leaders say some physicians may have failed to disclose their physician-ownership interests in entities that offer medical supplies to the physician’s own practice, as required under the Physician Payment Sunshine Act. The legislators on March 19 prodded the Health and Human Services' Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) to take a closer look into these arrangements.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 07 Mar 2019
Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 07 Mar 2019
4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
27 Feb 2019
The proposed IPO for GE's healthcare business could be off the table, CEO Lawrence Culp said as GE announced plans to sell its biopharma business to Danaher for $21.4bn. The deal will provide the conglomerate with a much needed cash injection to handle its rising debts.
Topic BioPharmaceutical Medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
27 Feb 2019
The UK government is introducing new registration requirements for medical devices in the event of a no-deal Brexit. They will be rolled out according to the risk class of products. But some fundamental questions have arisen.
Medtech Insight: 世界の医療機器・医療技術の最新情報
22 Feb 2019
Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes to the risk classification of spinal implants. Their work could also reduce the amount of unnecessary notified body and expert panel work on some implantable devices.
Topic Medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
22 Feb 2019
The global market for bone densitometers and bone turnover markers will reach $373.1m by 2023, driven in large part by the rising aging population and rising prevalence of osteoporosis.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
By ferdous-al-faruque 14 Feb 2019
Despite a recent report that Sen. Amy Klobuchar, D-Minn., is backing away from leading efforts to repeal the medical device tax due to her presidential ambitions, sources say she is working with Sen. Pat Toomey, R-Pa., to cosponsor a repeal bill this year. Similarly, on the US House-side, Rep. Ron Kind, D-Wisc., is calling on his colleagues to support a full repeal bill as well.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Ashley Yeo 14 Feb 2019
The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
07 Feb 2019
With a growing urgency for medtech manufacturers to take decisive action so their products are not banned from the market under an increasingly likely no-deal Brexit, clients of BSI will be relieved to hear their notified body believes time is on their side.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 07 Feb 2019
The US Department of Homeland Security National Cybersecurity and Communications Integration Center is warning of potential cybersecurity vulnerabilities in Stryker hospital beds and BD diagnostics equipment.
Medtech Insight: 世界の医療機器・医療技術の最新情報
01 Feb 2019
NSF International's Brian Ludovico explains why device-makers that already follow international quality systems standard ISO 13485 shouldn't be nervous about taking part in the Medical Device Single Audit Program. Ludovico also shares MDSAP participation numbers and says firms should feel at ease knowing that the program's auditing organizations undergo a rigorous process to become recognized by the MDSAP Regulatory Authority Council.
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