Cordis
This article was originally published in The Gray Sheet
Executive Summary
Plans to file premarket approval application for its electrophysiology catheter for radiofrequency ablation "within the next month," according to a spokesperson for the firm. Cordis joins Medtronic, with a PMA for an RF ablation catheter on file at FDA, and EP Technologies, whose RF ablation catheter won a recommendation for approval from FDA's Circulatory System Devices Panel in May ("The Gray Sheet" May 9, p. 2)
You may also be interested in...
Helping Organizations Deliver On KPIs And Giving Staff A Voice
ImproveWell has won awards for its software technology that allows health care staff at the sharp end of patient care to report on problems as they happen. The outcome is a real-time learning process that contributes to improved operational efficiencies for health systems, says In Vivo Rising Leader Lara Mott.
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.