Artificial Intelligence: Revolutionizing Medical Imaging

Recent developments in artificial intelligence hardware and software are revolutionizing the development of medical devices, and the technology is now widely used to process, predict and visualize medical data in real-time. AI is used in more than 350 FDA-approved medical devices, and countless more devices that provide operational savings in healthcare settings. Kimberly Powell, vice […]

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Toripalimab becomes the first domestically produced anti-PD-1 monoclonal antibody designated by the U.S. FDA as a breakthrough therapy

September 10thJunshi Bio announced that the company’s self-developed anti-PD-1 monoclonal antibody toripalimab (Tuoyi) for the treatment of nasopharyngeal carcinoma has recently been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA). Toripalimab became the first domestic anti-PD-1 monoclonal antibody to be granted breakthrough therapy designation by the US FDA, which is another […]

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Centrifugal Blood Pump Model Using COMSOL® Software

Computational fluid dynamics (CFD) modeling is an effective method for modeling fluid flow in cardiovascular applications and devices, and has been widely used to simulate hemodynamics in blood-contacting medical devices. Virtual testing using CFD modeling instead of physical testing methods enables device developers to speed development cycles, reduce costs, and validate device safety and efficacy […]

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Using Static Code Analysis of Medical Device Software

Medical devices use more software code than ever before. However, while software provides medical devices with more functionality and flexibility, it also introduces additional complexity that increases the risk of failure. About 20 percent of medical device recalls today are caused by software defects, and that number is rising. The Federal Drug Administration (FDA) oversees […]

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Future medical treatment is based on the progress of MATLAB, signal processing, machine learning and deep learning algorithms

Driving force | unveil the mystery of the application of artificial intelligence and machine learning in medicine After approval by the US Food and Drug Administration (FDA), the first batch of wearable digital health monitors have just been launched and integrated into consumer products such as smart watches. With the rapid development of medical sensor […]

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Development of technology in medical device industry

Development of technology in medical device industry 1. Overview of global medical device industry The medical device industry concerns human health and life safety. It is a multi-disciplinary, knowledge intensive and capital intensive high-tech industry. With the development of global aging and the continuous emergence of new technologies, the medical device industry has always maintained […]

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Two new features of applewatchseries 4 are licensed by FDA

According to foreign media reports, on September 12 local time, Apple announced that two new features of Apple watch series 4 have been licensed by the U.S. Food and Drug Administration (FDA). One is a heart monitoring function called electrocardiogram (EKG), and the other is a function that can detect the user’s irregular heart rhythm […]

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FDA approved a wearable tracking device, the remote patient monitoring platform

Recently, FDA approved a wearable tracking device from current health, That is, remote patient monitoring platform (RPM), as a class II medical device, is used for treatment and rehabilitation services after discharge. The approved device includes Bluetooth integration with other devices to track patient indicators, and the patient terminal is equipped with a chat device […]

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FDA introduces a tool for non clinical testing of ultrasound equipment

FDA has established the mddt program to support the development of validated, qualified methods, materials, and measurements. The goal is to reduce the risk and uncertainty of equipment development by providing the company with a set of tools and technologies accepted by FDA, rather than evaluating the tools used in the industry on a case […]

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Dhera takes the lead in digital healthcare for Alzheimer’s disease

The FDA has awarded the digital therapy of dthera sciences as a breakthrough device for patients with Alzheimer’s disease. Dthra’s device, dthr-alz, provides memory therapy to treat agitation and depression in some patients with Alzheimer’s disease. Upon receipt of the status information, dthera will benefit from FDA input and will give priority to review after […]

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