Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk ...
After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
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 ...
WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...
Shares of Intuitive Surgical (ISRG) slipped in the morning trading on Wednesday after the U.S. FDA said that the company has issued a safety alert linked to a defective product associated with its da ...
Prodeon Medical, a privately held medical device company focused on advancing minimally invasive therapies for urologic diseases, today announced it has received U.S. Food and Drug Administration (FDA ...
The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release. Dr.
Illinois Sen. Dick Durbin and Rep. Jan Schakowsky want an electronic format for medical device makers to quickly and transparently report recall information to federal regulators to improve what they ...
As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...
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