Updates to this list: The FDA plans to update this list on a periodic basis based on publicly available information. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information. This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. The FDA assembled this list by searching FDA’s publicly-facing information, as well as by reviewing information in the publicly available resources cited below (*) and in other publicly available materials published by the specific manufacturers.
The FDA is providing this list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area.Ĭontents of this list: This list contains publicly available information on AI/ML-enabled devices. Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed (via 510(k) clearance, granted De Novo request, or approved PMA) with ML across many different fields of medicine-and expects this trend to continue. Interest in medical devices incorporating ML functionality has increased in recent years. One of the greatest potential benefits of ML resides in its ability to create new and important insights from the vast amount of data generated during the delivery of health care every day. With this update, the FDA has also added the ability to download the list as an Excel file.Īs technology continues to advance every aspect of health care, software incorporating artificial intelligence (AI), and specifically the subset of AI known as machine learning (ML), has become an important part of an increasing number of medical devices. Some patients would require cardiopulmonary support during surgery.Octoupdate: 178 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices were added to the list below. Not all patients are candidates for beating heart procedures. Multiple sizes are available to accommodate all vessel diameters, including the first 1mm intracoronary shunt. The soft silicone body with tapered tips is designed for atraumatic insertion and removal. The ClearView Shunt provides a clear anastomotic site during the procedure while providing blood flow to the distal myocardium. An irrigation mist gently clears blood from the site, improving visualisation without drying or desiccating delicate tissue. The ClearView™ Blower/Mister is designed to improve visualisation of the surgical site.
Specialised nozzle, utilising a micro-orifice for fluid delivery and a separate orifice for gas delivery.The malleable shaft and on/off control on the handpiece make it an excellent choice for facilitating a bloodless field. The AccuMist™ Device offers advanced fluid/gas mixing technology to create a consistent, predictable blood clearing mist.
Accessory Overview AccuMist Blower/Mister
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