Market authorization for digital medical devices
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Image: Tablet lying on a table, a person in a doctor's coat reaches for the tablet with both hands

AI: New testing framework to ensure the quality of training data

24/09/2024

A testing framework has been developed at Germany’s national metrology institute, the Physikalisch-Technische Bundesanstalt (PTB), to ensure the quality of training data for medical AI applications. The framework, as well as a tool for the automated testing of algorithms, will be available to all developers.
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Image: Person examining another person's legs for deep vein thrombosis using an ultrasound device

AI-based wearable for early detection and prevention of deep vein thrombosis

13/08/2024

The VDE is participating in the EU project ThrombUS+, which aims to improve risk assessment and prevention of deep vein thrombosis with a portable vein analyzer and an AI-based diagnostic device. In an interview with MEDICA-tradefair.com, Dr. Thorsten Prinz describes the three-and-a-half-year project.
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Image: Preview picture of video

Market authorization for digital medical devices – anything but simple

05/01/2024

At MEDICA 2023, we spoke to exhibitors who advise manufacturers of digital medical devices during the authorization process or who are launching digital medical devices on the market themselves. In the video, you can find out what is particularly important in the authorization process and where the stumbling blocks lie.
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Image: Portrait photo of Stefanie Brückner. A woman with brown hair in a striped shirt; Copyright: Anja Stübner, EKFZ für Digitale Gesundheit

Anja Stübner, EKFZ für Digitale Gesundheit

Informed consent to the use of personal health data

22/11/2023

Millions of people worldwide use health and wellness applications to record health-related parameters such as symptoms, step count or heart rate in their everyday lives. This citizen-generated health data provides previously unknown information about a person's experience of illness and health.
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Image: Three images representing the three areas of the DHU project; a doctor selecting digital icons in the air, an online and offline meeting; Copyright: Digital Health Uptake

Digital Health Uptake

Digitization: "A common vision is missing."

26/10/2023

Digitization is a perennial topic in the healthcare sector. Much has been written about the opportunities and dangers. But why is progress so slow in Germany and where do other EU countries stand?
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Image: Fraunhofer IPA’s experimental hybrid operating theatre in Mannheim; Copyright: Fraunhofer IPA

Fraunhofer IPA

Research project DAIOR: Distributed artificial intelligence for the OR

10/10/2023

A research team of scientists has jointly launched the DAIOR project ("Distributed Artificial Intelligence for the Operating Room"). Within the framework of the project, the project partners are working on realizing the operating room (OR) of the future with help of artificial intelligence (AI) and robot assisted telemedicine.
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Image: A person sits in front of a laptop, a graphic representation of a head in cross-section as an AI is displayed above the laptop; Copyright: AndersonPiza

AndersonPiza

Danger from chatbots: Do they need regulation as a medical device?

12/09/2023

Chatbots like ChatGPT have great potential for medicine. But their unregulated use in healthcare poses a great danger because of their inherent risks. A Nature Medicine article by Prof. Stephen Gilbert et al. calls for medical device approval for chatbots and applications based on them.
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Image: Prof. Stephen Gilbert, blond man in dark blue shirt, poses for the camera; Copyright: EKFZ/ A. Stübner

EKFZ/ A. Stübner

Chatbots like ChatGPT: approval as medical devices

06/07/2023

The new Nature Medicine paper by Prof. Stephen Gilbert, et. al. addresses one of the most pressing international issues of our time: How to regulate Large Language Models (LLMs) in general and specifically in health.
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