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.
IGI Bets On Trispecific Antibody To Make Inroads Into Big Pharma Myeloma Turf
Ichnos Glenmark Innovation’s president and CEO talks to Scrip about the promising activity profile of the alliance’s early stage trispecific antibody versus Janssen’s teclistamab and also maintains that the setback for Gilead’s magrolimab hasn’t eclipsed prospects for its bispecific antibody.
UK Medtech Strategy Sets Out Schedule Of Milestones To FY 2026
Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.