Medical devices - World Health Organization (WHO)
2021年6月30日 · A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.
Medical devices - World Health Organization (WHO)
2011年4月6日 · Medical equipment is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury; it can be used either alone or in combination with any accessory, consumable or other piece of medical equipment. Medical equipment excludes implantable, disposable or single-use medical devices.
MeDevIS platform announced to boost access to medical …
2024年7月8日 · MeDevIS references two international naming systems for medical devices - the European Medical Device Nomenclature , mostly used in European countries for registration in the European database, and the Global Medical Device Nomenclature used in regulatory agencies in Australia, Canada, the United Kingdom and the USA and other Member States. The ...
The number of AI medical devices has spiked in the past decade
2024年10月9日 · The FDA last updated the database on Aug. 7, 2024. The FDA compiled the list using product codes and device summaries. The list is not exhaustive, but it is intended to be representative of devices that incorporate AI/ML across medical disciplines, the agency said. The definition of a device includes hardware and software features.
Prioritizing medical devices - World Health Organization (WHO)
2021年7月30日 · Medical devices include from a syringe, catheters and surgical mask, to complex devices like pacemakers and prothesis to magnetic resonance. WHO global lists of priority medical devices help improve access to suitable medical devices, increase safety, support quality of care and strengthen health care systems.
Medical Technology News | MedTech Dive
MedTech Dive provides medical technology news and analysis for industry professionals. We cover medical devices, diagnostics, digital health, FDA regulation and compliance, imaging, and more.
Management and Safe Use of Medical Devices - World Health …
Medical devices should be safe, of good quality and appropriate to the settings in where they are used. Recognizing this important role of health technologies towards universal health coverage, the World Health Assembly adopted resolution WHA60.29 in M
Medical Device News - MedTech Dive
6 天之前 · Medical device industry continues to turn to AI. While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective. By MedTech Dive staff
All Medical Devices & Technology Articles - Harvard Health
2024年12月1日 · One device is a modification of a system to treat mitral valve regurgitation that works by bringing the valve leaflets together at the areas of most severe leakage. The other device delivers a new valve made of cow heart tissue, which …
Nomenclature of medical devices - World Health Organization …
A76/7 Rev.1 Standardization of medical devices nomenclature (13.7) . Decision WHA75(25) Standardization of medical devices nomenclature. Previously, during the 152 Executive Board in January 2023, a report was presented: EB152/11. In May 2023, a decision referring to medical devices codes, terms, and definitions was taken: WHA75(25).