Update to Food and Drug Administration Regulation of Stroke Neurological Devices

被引：6

作者：

Pena, Carlos ^{[1
]}

Anderson, Leigh ^{[1
]}

Brooks, Claudette ^{[1
]}

Bydon, Mohamad ^{[1
]}

Fusco, Matthew ^{[1
]}

Heetderks, William ^{[1
]}

Herrmann, Robert ^{[1
]}

Hoffmann, Michael ^{[1
]}

Loftus, Christopher ^{[1
]}

Raben, Samuel ^{[1
]}

Seog, Joonil ^{[1
]}

Noonan, Patrick ^{[1
]}

Smith, Myra ^{[1
]}

Williams, Dhanya ^{[1
]}

Zheng, Xiaolin ^{[1
]}

机构：

[1] US FDA, Div Neurol & Phys Med Devices, Ctr Devices & Radiol Hlth, 10993 New Hampshire Ave, Silver Spring, MD 20993 USA

来源：

STROKE | 2019年 / 50卷 / 02期

关键词：

cosmetics; diagnosis; radiologic health; stroke; tobacco;

D O I：

10.1161/STROKEAHA.118.021078

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Today, many medical devices are currently marketed for the treatment of large vessel occlusions in ischemic stroke, for use in patients who suffer from these life-threatening conditions. The Agency is also committed to monitoring devices through the product’s total life cycle, and cooperating with the diverse parties primarily involved at each phase of the cycle (research, development, clinical investigation, performance in the real world of clinical practice after market release, and incorporating the subsequent technological improvements or changes into devices making them available for the US public). The FDA stands ready to assist any Sponsor and Principal Investigator(s) to address stroke intervention and to accelerate promising medical devices to the public.2 Ongoing dialogs with all stakeholders, continuing research and development of medical products, and expediting innovative technologies to better treat patients and provide hope to their families will be essential if we are to continue to realize more safe and effective treatments for this devastating disease. © 2018 American Heart Association, Inc.

引用

页码：524 / 528

页数：5

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