Withings ScanWatch has received CE certification for medical devices and is now available in Europe.
medical device
A kit that allows the doctor to see, hear and measure at a distance
One of the major limitations of the televisit is the difficulty of examining the patient’s main organs due to physical distance.
The effect of COVID-19 on the new medical device regulation
The COVID-19 also affected the regulatory system of medical devices. In fact, in the face of the health emergency, the European Commission has presented a legislative proposal to postpone for one year the date of application of the new regulation on medical devices.
Control phones and computers with your thoughts: Elon Musk’s latest challenge
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
Migraine? Let’s treat her with a smartphone.
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
Certification as a medical device of a machine-learning software: the path of FDA
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
Why the medical software certification will revolutionise the market in EU
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
