Feb 22, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) cleared Brainlab’s Loop-X® Mobile Imaging Robot and Cirq®, a robotic surgical system. The clearance paves way for Brainlab to market in the U.S. market for both devices. Cirq robotic alignment module is meant for... 
Feb 4, 2021 | Health, Language Service Provider, Medical Translation
There is no doubt that medical devices are vital tools that not only enhance quality of life, but also save lives. From invitro diagnostic devices (IVD) like HIV blood diagnostic tests and blood glucose self-testing to software as a medical device (SaMD) that have... 
Jan 19, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as... 
Dec 15, 2020 | News, Regulatory
Under its Abbreviated 510k Program, the U.S. Food and Drug Administration (FDA) outlined guidelines for the Safety and Performance Based Pathway, a fast track for medical devices in well established categories to gain market... 
Nov 25, 2020 | News, Regulatory
A wide variety of medical technology devices are being more rapidly reviewed and tested for patient use through the U.S. Food and Drug Administration (FDA) Breakthrough Device List. Among the list of innovations are two breast cancer diagnostic tests along...
