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: 世界の医療機器・医療技術の最新情報
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
The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.
Medtech Insight: 世界の医療機器・医療技術の最新情報
Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But there is a strong lobby pushing for paper IFU to still be made available.
Medtech Insight: 世界の医療機器・医療技術の最新情報
Updates to the EU Medical Devices Regulation are just weeks away from becoming a reality for manufacturers and suppliers. Medtech Insight delivers expert insights into the latest developments and what they could mean for your business.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
Medtronic said it will launch the SenSight DBS in the US after winning FDA approval. The total DBS market is expected to exceed $1bn by 2024, according to Meddevicetracker.
Medtech Insight: 世界の医療機器・医療技術の最新情報
Keep current with comprehensive coverage of today’s deals and their impact on the future of the medtech landscape. Medtech Insight brings you insight and analysis of significant recent deals and what they mean for your strategy. Stay in the know with your free Quarterly Roundup.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.
Medtech Insight: 世界の医療機器・医療技術の最新情報
The UK’s new medical device registration system, one element of the post-Brexit transition being overseen by the MHRA, is going more or less to plan in the early stages of the standstill period.
Medtech Insight: 世界の医療機器・医療技術の最新情報
A US FDA official says the agency’s taking steps to plan for post-pandemic on-site inspections that could look slightly different than typical agency audits pre-COVID-19. But in the interim, some companies are being asked to participate in voluntary Remote Regulatory Assessments.
Medtech Insight: 世界の医療機器・医療技術の最新情報
The next-generation TriClip G4 comes in more sizes than the original TriClip and features enhanced leaflet grasping features.
Medtech Insight: 世界の医療機器・医療技術の最新情報
At last, the EU has reached its milestone of having 20 notified bodies designated under the Medical Device Regulation. And Finland now boasts two.
Medtech Insight: 世界の医療機器・医療技術の最新情報
The US FDA on 24 March gave its highest risk designation to a recall of the company’s Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir. The device is used on newborns, infants and small pediatric patients undergoing a cardiopulmonary bypass procedure.
Medtech Insight: 世界の医療機器・医療技術の最新情報
GE Healthcare has announced the launch of Vscan Air, its first wireless ultrasound device.
Medtech Insight: 世界の医療機器・医療技術の最新情報
The report looks at a broad range of submission and product types and concludes use of RWE/RWD has helped get new products to market faster.
Medtech Insight: 世界の医療機器・医療技術の最新情報
The US FDA issued a new template for serology test-makers that detect or correlate to neutralizing antibodies, and also updated an existing template to reflect concerns over viral mutations
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