1. Medtech Insight
  2. >>Device Area
  3. >>Surgery
  4. >>Surgical Procedures

FDA Green-Lights Medrobotics' Flex Robotic System For Transoral Head And Neck Surgery

Medrobotics Corp. recently received US FDA 510(k) clearance for its Flex Robotic System for transoral head and neck surgery, a market estimated at roughly $1 billion in the US alone. Although Medrobotics is only the second company to bring a robotic soft-tissue surgical system to market in the US, other novel systems are in development, including a unique robotic system for needlescopic procedures.

In July, Medrobotics Corp. became the second company ever to receive FDA 510(k) clearance for a robotic soft-tissue surgical system. Unlike the da Vinci Surgical System from Intuitive Surgical Inc., which was approved in 2000 and uses rigid, straight instruments with articulating ends, the Flex Robotic System features a flexible scope and instruments that a surgeon can precisely direct with up to 180-degree turns through the body’s tortuous paths. In March 2014, the device received CE mark in Europe, where it has garnered great success, according to Medrobotics president and CEO Samuel Straface, PhD.

Flex was invented and then patented in 2005 by Carnegie Mellon University in Pittsburgh, PA, where Medrobotics was incubated,...

More from Surgical Procedures

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Bone Surgery Startup Surgify Medical Raises $7.9m

 
• By Natasha Barrow

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

More from Surgery

Bone Surgery Startup Surgify Medical Raises $7.9m

 
• By Natasha Barrow

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Axoft Starts Commercializing Soft BCI-Enabling Materials For R&D Use, Aims To Rewrite BCI Playbook

 
• By Marion Webb

After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.