Regulate Robotic Surgery Devices By Function, Not Indication, Stakeholders Tell FDA
This article was originally published in The Gray Sheet
Executive Summary
Industry and physicians speaking at a two-day FDA meeting on robotically-assisted surgical devices emphasized the need to regulate the technology as any other surgical tool, with Intuitive Surgical proposing a new regulatory paradigm to accomplish that. Meanwhile, the company and surgeons differ on who should be leading physician training on the robotic systems.
You may also be interested in...
FDA Surgeon Survey Finds Variation In Training With da Vinci System
An FDA survey of 11 surgeons with experience using Intuitive Surgical’s da Vinci robotic surgical system shows respondents reported having difficulty learning how to use the device’s complex user interface.
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.