Source: MedRobot; Edited by: Tang Zijie Reprint Requirements: Can be reprinted 24 hours after the first release, with source acknowledgment This article reviews five orthopedic navigation and surgical robot products that received approval from the U.S. Food and Drug Administration (FDA) from January 2022 to the end of August, from three American companies: Surgalign (NASDAQ: … Read more
So far, more than 10 types of antibody-drug conjugates (ADC) have been approved by the U.S. Food and Drug Administration (FDA) and have contributed to the medical field. Interestingly, they are all manufactured using chemical conjugation techniques. This indicates that chemical conjugation is the primary method for ADC manufacturing. Compared to other conjugation techniques such … Read more
With the intelligence and informatization of medical devices, many off-the-shelf software (OTS) are being applied in medical devices. On August 11, 2023, the FDA released the Guidance for Industry and Food and Drug Administration Staff on Off-The-Shelf Software Use in Medical Devices, which aims to provide information that applicants should include in the documentation submitted … Read more