MedCity News June 14, 2024
Erez Kaminski

Cutting-edge technology empowers developers to proactively detect and mitigate issues before they cause problems, reducing recalls and fostering trust in the industry.

In 2023, the FDA identified 62 medical device recalls with 42 identified to date in 2024. Most recently, Tandem Diabetes Care recalled its Apple iOS app after over 200 reported injuries. While the issues behind the 2024 recalls are diverse, software problems are an important theme. Software, while transformative for healthcare and other safety-critical sectors, poses significant risks when it fails — as in the high-profile cases of the Boeing 737 Max 8 and Tesla. For medical device manufacturers, detecting and addressing software issues is vital to ensure patient safety — especially as devices increasingly depend on software...

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