How Proactive Cybersecurity Can Protect Insulin Pump Users
Medtech Insight spoke to MedCrypt director Naomi Schwartz about how proactive cybersecurity can ease premarket burdens for diabetes care manufacturers.
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The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.
A discussion of Japanese and American digital health regulations at CRT2023 in Washington, DC, explored the similarities between the two countries and how we regulate software and connected devices.
The pace of artificial intelligence development has accelerated in recent years and now most of the artificial intelligence devices approved by the FDA are imaging devices.