Elon Musk’s Neuralink, the secretive company developing brain-machine interfaces, showed off some of the technology it has been developing to the public for the first time. The goal is to eventually begin implanting devices in paralyzed humans, allowing them to control phones or computers. Continue reading
On May 28, the U.S. Food and Drug Administration (FDA) authorized Theranica, an Israeli biomedical technology company, to market Nerivio Migra®, an electronic device controlled by smartphone for the acute treatment of migraine. Continue reading
FDA has published a 20-page white paper on how to set up certification as a medical device of machine-learning software (SaMD). Continue reading
As foreseen by the new Medical Devices European Rules (UE 2017/45), to be operational from 26 May 2020, and by the Court of Justice sentence of 7 December 2017, medical software shall be certified as medical devices (MD) class IIA (with the exception of software aimed to archive, store and transmit data without any data elaboration and added value). This will have a great impact on the market. Continue reading
