In 2006, FDA launched what the agency refers to as a postmarket transformation initiative. Developed through FDA's Center for Devices and Radiological Health (CDRH), the initiative is designed to ...
Electronic medical devices could provide a route for hackers to gain access to individuals' health data and even interfere with aspects of care delivery. Therefore, a key challenge for device makers ...
Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
HONG KONG, March 13 (Reuters) - China's drug regulator said on Friday that it has given the nod for a brain-computer ...
The integration of connected medical devices into healthcare systems is rapidly transforming patient care, diagnostics, and treatment methodologies. Using technologies such as wireless connectivity, ...
A popular medical monitor is the latest device produced in China to receive scrutiny for its potential cyber risks. However, it is not the only health device we should be concerned about. Experts say ...
The FDA has published medical imaging guidance for patients with electronic medical devices after receiving some reports of device interference occurring during CT scans. The number of reports the FDA ...
In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...
At last year's annual meeting of the Regulatory Affairs Professionals Society (RAPS), the former head of FDA's postmarket management transformation group, Don St. Pierre, updated attendees about the ...
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