As connected medical devices become more commonplace, device manufacturers should prepare for helpful hacking and consider how to address potential recalls that may arise. Kevin Pollack It's difficult ...
Evolving regulatory requirements and AI capabilities are reshaping quality management in the medical device industry. With increasing focus on compliance, traceability and patient safety, ...
Medtronic’s introduction of its Artificial Intelligence (AI) enabled colonoscopy system turned a few heads at JP Morgan this year. J&J’s surgical partnership with NVIDIA is now building on the earlier ...
The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...
In conversations about medical device cybersecurity, attention focuses on the Food and Drug Administration’s (FDA) rules and guidelines. With a refresh in 2023 that emphasized new protocols for ...
The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device technology. In 2024 alone, 30 new devices were approved by the US Food and Drug ...
The healthcare landscape has changed dramatically since I first entered a surgical suite in the early 2000s. Over the past two decades, with the rise of corporate entrants into healthcare—including ...
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