The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

A federal judge in Texas has ruled that the FDA does not have the authority to regulate laboratory developed tests as medical devices, striking down the agency’s recently finalized rule. The decision, ...

FDA can take action if it believes the changes require a new marketing submission. The recent Warning Letter highlights a critical aspect of medical device regulation: while a device may initially ...

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services.

RFK Jr. should accept the ruling and instruct the agency to immediately halt all efforts to regulate laboratory-developed and ...

The first stage of the new FDA rule was set to take effect May 6, requiring compliance with medical device reporting, correction and removal, and maintenance of complaint files. The rule would then ...

April 18, 2025 /PRNewswire/ -- On April 7, 2025, the U.S. Food and Drug Administration ("FDA" or "the agency ... Q'Apel has submitted three Medical Device Reportable events for the Hippo ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...

which reflects the FDA’s commitment to device innovation and protecting public health, is intended to help patients and health care providers receive more timely access to select medical devices.