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Pretesting : a targeted first analysis to investigate on induced risks due to medical devices in MRI

The exposure of a medical device to the MRI environment may induce risks, especially when the device consists of conductive, magnetic or metallic materials. These risks must be assessed to meet regulatory requirements in most markets.For regulatory affairs, testing is required. However, while essential to accurately assess risks, testing is often time-consuming and costly. With […]

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Update of the FDA Guidance „Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment“

📣 We would like to inform you of the recent publication of an update about the guidance „Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment“ by the #FDA (Food and Drug Administration). 📚 This FDA guidance is a valuable resource for medical device manufacturers wishing to assess the safety of their products in […]

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Numerical modelling : reliability, experience and dedicated tools

In MRI environment, the radiofrequency heating of implanted medical devices can be significant, and may be a risk for patients. This heating is acute and depends on multiple factors, thus for multi-configurational devices, it is often impossible to predict the worst-case by a simple rationale. At Healtis, we have an expert team and specific tools dedicated to the numerical modeling of heating due to […]

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Update RE: ASTM F2503 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment)

Healtis would like to inform all medical device manufacturers that on May 25th of this year, a new version of the MRI Labelling document ASTM F2503 ‘Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment’ was issued. Healtis is currently studying the impact this new version has on […]

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