The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also ...

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Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making processes, explainability is essential to enhance trust, safety, and ...

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department ...

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...

ExThera Medical has been awarded funding by the Medical Technology Enterprise Consortium (MTEC) to perform a randomized controlled trial to evaluate the efficacy of the Seraph ® 100 Microbind ® ...

Cybersecurity has become a leading priority for manufacturers of embedded systems and IoT devices. The rapid proliferation of ...

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent ...

Here is the review for the handset after using it till two months. The HMD Fusion emerges as an intriguing device with a modular design, likely to attract enthusiasts who enjoy customizing their ...