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Carthera, a French medtech company that makes ultrasound-based medical devices to treat brain disorders, has earned the FDA’s Breakthrough Device designation for its SonoCloud-9 system. Read More
The antimicrobial susceptibility testing device received a Breakthrough Device designation from the FDA earlier this year, but it has not yet received the agency’s 510(k) clearance. Read More
Due to its ability to differentiate between natural and vaccine-based antibodies, the PictArray test could help in future vaccine development, the company said. Read More