BDX wins FDA 510(k) clearance for the EnCor EnCompass breast biopsy system, set for an early 2026 launch to boost flexibility and patient care.

According to Leadoptik's FDA application, the LIA catheter is an OCT-guided biopsy needle designed for use with endobronchial ...

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 ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a J&J catheter.

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

Milestone Pharmaceuticals, a Canadian company with a U.S. subsidiary in Charlotte, is starting the new year with its first ...

FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...