The FDA has approved a new type of painkiller that doesn't come with the risks of addiction and overdose associated with opioids.

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 Food and Drug Administration announced the approval of a new non-opioid pain medication this week, marking the first time ...

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

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 ...

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.

Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...

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.