Tag Archives: Focus Article – Homepage

Thomas Ring

Designing Compliant Wireless Medical Devices

By Thomas Ring
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Thomas Ring

Medical Electronic Products of the future will be largely free from wires and cables, aside from a power source. “Wireless medical devices” offer numerous advantages. However, they are also subject to extensive legal regulations governing aspects such as the radio technology used in them. In addition, they may have to be assessed by a Notified Body such as TÜV SÜD.

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PreciseDX

How AI Can Advance Breast Cancer Detection and Treatment

By Ted M. Diehl, Wayne Brinster
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PreciseDX

The integration of artificial intelligence (AI) into breast cancer detection and treatment is already making a profound impact. AI-powered algorithms enhance early detection by analyzing vast amounts of data and identifying subtle abnormalities often invisible to the human eye. These technologies empower healthcare professionals to make informed decisions, improving the accuracy of diagnoses and tailoring treatment plans to the specific genetic makeup and health conditions of individual patients. This integration represents a paradigm shift in the cancer care continuum.

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Karl Hoelper
Soapbox

Realizing RFID’s Potential in Healthcare: Tackling Closed-Loop System Hurdles

By Karl Hoelper
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Karl Hoelper

The use of Radio-Frequency Identification (RFID) technology in healthcare, particularly within closed-loop systems, presents complexities, including potential limitations on interoperability that can affect patient safety. Here we look at key challenges including data silos, interoperability barriers, market fragmentation, impediments to innovation and operational inefficiencies.

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Christian Götz and Dr. Jara Brenke

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

By Christian Götz, Dr. Jara Brenke
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Christian Götz and Dr. Jara Brenke

Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.

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