Dialysis For Heart Failure? FDA Panel Urges Randomized Trials First
This article was originally published in The Gray Sheet
Executive Summary
Randomized clinical trials are needed to allow blood filtration devices to be labeled for heart failure treatment, according to FDA's gastroenterology and urology devices panel
You may also be interested in...
Devices In Drug Land: Med-Tech Firms Try To Break Into Pharma Territory
Medical device companies are targeting everything from headaches to psychiatric disorders and from digestive diseases to cardiac conditions in an effort to win over just a portion of these and other multibillion-dollar drug-dominated markets
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
How Ochre Bio Bagged Boehringer For Its RNA-Based Regenerative MASH Therapies
UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.