LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.

Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory ...

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 ...

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...

Impella devices have been the subjects of a series of Abiomed letters and FDA early alerts and recall notices. In January, Abiomed sent an urgent medical device correction about a malfunction risk ...

FDA has scrapped a final rule that was implemented in May 2024, which required the application of medical device rules to laboratory-developed tests. The new rule, effective September 19, 2025, ...

As 2025 draws to a close, the state of the federal system of regulatory affairs in the United States continues to operate in a somewhat chaotic fashion. FDA has perhaps been most affected by changes ...

Key opportunities in the drug delivery devices market include expanding digital health partnerships for innovative injectable and connected solutions, addressing chronic conditions like asthma and ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Ultrasonic spray coating parameters such as drug-to-polymer ratio and carrier gas flow impact coating thickness/profile and ...