Electrosurgical Device 510(k) Guides Issued By FDA
Executive Summary
The US agency released two final guidance documents with tips on 510(k)s for electrosurgical devices targeting general tissue cutting, coagulation or sealing indications.
You may also be interested in...
US FDA Updates Electrosurgical Devices Guidance To Reflect Thermal Damage Testing Recommendations
More than three years after issuing a final guidance on electrosurgical devices, the US FDA is clarifying its thermal damage testing recommendations following sponsor feedback. The update includes recommendations for the types of tissue that the devices should be tested on depending on the indicated use.
China VBP, Localization And Other Strategies - How Far And Which Way?
Could health sector players encounter issues similar to those facing Tesla in China, a country which virtually saved the electric vehicle maker but where it is now facing challenges? Are there any lessons to be learned from a success story under China's volume-based procurement scheme? A partner at EY looks at these and other issues in an interview with Scrip.
Ratio Therapeutics On BMS Investment, Radiopharma R&D Trends, AI Use
The CEO and CSO of radiopharmaceutical company Ratio Therapeutics, which now has Bristol Myers Squibb as an investor, talk about Ratio’s R&D platforms, use of AI, an independent FAP-targeted asset and trends in radiopharma research such as combining other modalities like ADCs, in this podcast interview with Scrip