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.
You may also be interested in...
Intuitive Surgical's latest earnings and procedure numbers beat analysts' expectations and further solidified its leading position in surgical robotics. But potential robotic rivals are in the wings with alternative solutions that could make robotic surgery more affordable and accessible, including Cambridge Medical Robotics, Transenterix, Titan Medical, SOFAR and J&J/Google.
With up to $100m from Abingworth and a recent $75m FOPO, CymaBay has runway to await pivotal data in primary biliary cholangitis in 2023 for seladelpar, after the candidate failed in NASH. It sees a significant market opportunity in the second-line setting cornered by Intercept.
The US agency and the medtech industry still have significant disagreements, which means they will miss a 15 January deadline to send the MDUFA V user-fee deal to Congress. Insiders disagree, however, on how severe those disagreements are and when a deal can be reached.