UW Medicine is unveiling an FDA-approved spinal cord therapy in an effort to offer new hope for paralyzed patients.

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

The U.S. Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or ...

WASHINGTON — Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and ...

The prescription pills, sold under the brand name Journavx and made by Vertex Pharmaceuticals, are taken twice a day and represent the first new class of pain medications in 20 years—and the first non ...

Alterity plans to seek US FDA fast-track approval after posting positive phase II results for multiple system atrophy ...

An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...

The FDA has granted medical manufacturer Beckman Coulter a Breakthrough Device Designation for its new plasma ratio, a blood ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

TAVIPILOT Soft is said to be a ‘world-first’ provision for real-time surgical guidance during TAVI and TAVR procedures.

This piece is part of a series that dives deeper into the most prevalent themes of this year’s iteration of our flagship research piece, Charting Disruption. Click to read.