24 January 2022 - Magnesium Development Company's fixation solution, the HC Screw, has received the FDA’s breakthrough device designation, having exceeded ...
21 January 2022 - Cook Medical has received breakthrough device designation from the US FDA on a new drug eluting stent ...
19 January 2022 - Patho-Seq uses next generation sequencing to rapidly identify bacteria from human samples during dangerous and life-threatening ...
19 January 2022 - Sensydia today announced that its cardiac performance system has been granted breakthrough device designation by the United ...
18 January 2022 - First prognostic blood test that can predict likely progression to Alzheimer's disease up to six years in ...
18 January 2022 - NeuroMetrix today announced that its Quell technology has received breakthrough designation from the U.S. FDA for reducing ...
4 January 2022 - Cullinan Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for CLN-081 for ...
4 January 2022 - There are currently no approved cancer therapies specifically for patients with c-Met overexpressing non-small-cell lung cancer. ...
23 December 2021 - First breakthrough therapy designation for patritumab deruxtecan based on results of Phase 1 trial. ...
16 December 2021 - Indication for pre-surgical vein dilation use to promote AV fistula creation. ...
13 December 2021 - InterVene announced today that it has received breakthrough device designation by the FDA for the company’s BlueLeaf ...
9 December 2021 - FDA granted designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy Based on results of REDWOOD-HCM. ...
7 December 2021 - Linus Biotechnology today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health ...
1 December 2021 - RefleXion Medical today announced that the U.S. FDA has granted the company breakthrough device designation for ...
1 December 2021 - The technology is a first of its kind molecular pathway designed to suspend cancer, inhibit pain, and ...