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The FDA has named Kevin Fu as acting director of medical device cybersecurity within the Center for Devices and Radiological Health (CDRH) — a newly created position in response to the agency’s growing concerns about cybersecurity threats. Read More
Health officials are using new tools to gather postmarket safety data on COVID-19 vaccines, including a new early warning system called V-Safe. Read More
The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize, as well as a standardized dataset to be included in test result certificates. Read More
According to the company, the system is the first and only neuromodulation technology that has shown statistically significant efficacy in eliminating migraine symptoms within two hours after treatment. Read More
The device is meant to be used as an aid in identifying patients who have an adaptive immune response to the coronavirus in order to detect recent or prior infection. Read More
The point-of-care OCT imaging platform provides ultra-high-resolution image volumes of the margin of an excised tissue specimen, visualizing microscopic tissue structures 1 mm to 2 mm below their surface. Read More
The catheter uses a dynamic cage to separate clots from vessel walls while simultaneously drawing clots into itself, macerating them and transporting them out of the body. Read More