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 Shawn M. Schmitt 14 Aug 2019
Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.
Topic fda
Medtech Insight: 世界の医療機器・医療技術の最新情報
14 Aug 2019
The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
06 Aug 2019
US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.
Topic fda digital-health medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
06 Aug 2019
Cancer diagnostics company Exact Sciences is combining with Genomic Health in a major merger valued at $2.8bn. The combined company will offer two of the fastest growing brands in cancer diagnostics, Cologuard and Oncotype DX.
Topic Cancer Business strategies
Medtech Insight: 世界の医療機器・医療技術の最新情報
26 Jul 2019
The fear of losing business by being transparent about cybersecurity vulnerabilities means there's "a perverse incentive in some parts of the market that encourages a lack of disclosure," Siemens' Harrison Wadsworth says. But the US FDA's Suzanne Schwartz believes coordinated vulnerability disclosure legislation could "level the playing field."
Medtech Insight: 世界の医療機器・医療技術の最新情報
By ferdous-al-faruque 26 Jul 2019
In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.
Topic fda policy-and-regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
12 Jul 2019
This year, Omron Healthcare launched its new HeartGuide smartwatch and the first FDA-cleared blood pressure monitor with EKG capability. Medtech Insight sat down with Omron's CEO Ranndy Kellogg to learn about upcoming plans.
Topic fda digital-health
Medtech Insight: 世界の医療機器・医療技術の最新情報
12 Jul 2019
The US agency's Case for Quality Voluntary Improvement Program – used to measure a device-maker's manufacturing maturity and quality – has surprisingly been used to assess some pharmaceutical facilities. Meanwhile, regulators from other countries have been reaching out informally to the FDA to learn more about CFQ VIP.
Topic fda policy-and-regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Bernard Murphy 05 Jul 2019
Enhancing trust in medical devices and medtech companies is the aim of a new agreement between the Spanish medtech industry and an organization specializing in helping businesses meet and maintain high legal and ethical standards.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 05 Jul 2019
The European Commission came under a great deal of pressure in June to deliver the fundamental structures and documents needed for implementing the EU’s new medtech regulations. It has hit the ground running so far this month.
Topic Policy and regulation
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Amanda Maxwell 03 Jul 2019
The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.
Topic Brexit
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Ian Schofield 03 Jul 2019
Changes are being made to the UK’s Accelerated Access Collaborative to help streamline access to ground-breaking medicines and diagnostic tools in areas like dementia, diabetes and cancer.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By Bob Kronemyer 02 Jul 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
Meddevicetracker: 医療機器の市場調査分析・データベース, Medtech Insight: 世界の医療...
02 Jul 2019
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
By Amanda Maxwell 02 Jul 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.
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