Original premarket approvals are taking “substantially longer” than last year, according to a report from BTIG.

The U.S. Food and Drug Administration (FDA) has officially dropped its warning letter and enforcement complaint against Whoop ...

BTIG analyst Ryan Zimmerman said while the increase in approvals is promising, longer decision times may have financial implications.

The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating ...

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, ...

In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...

With increasing interest in and demand for patient-specific medical devices, such as anatomically matched 3D printed implants ...

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 ...

J&J’s Abiomed and manufacturing partner Oscor warned of a bleeding risk from devices used to introduce catheters to the body.