1 March 2021 - Cook Medical’s Zenith fenestrated+ endovascular graft product has received breakthrough device designation from the US FDA. ...
2 March 2021 - Anuncia received U.S. FDA breakthrough device designation for its ReFlow System Mini intended for the treatment of ...
1 March 2021 - Apollo Endosurgery announced today that it has received a breakthrough device designation from the U.S. FDA for ...
25 February 2021 - Exelixis expects to submit supplementary New Drug Application in 2021. ...
24 February 2021 - Algorithm for earlier detection of gastro-intestinal bleeding. ...
24 February 2021 - Kura Oncology today announced that its investigational drug, tipifarnib, has been granted breakthrough therapy designation by the ...
24 February 2021 - The Company’s second FDA Breakthrough Device designation granted in 2021. ...
23 February 2021 - Inovise Medical today announced the U.S. FDA has granted breakthrough device designation for its Audicor heart failure ...
22 February 2021 - Innovent Biologics today jointly announce that the Center for Drug Evaluation of China's National Medical Products Administration ...
19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...
11 February 2021 - Recent Medicare reimbursement ruling provides an additional boost in paving the way for elimination of one of ...
11 February 2021 - The breakthrough device designation, which comes after new trial data, is expected to expedite the device's path ...
11 February 2021 - Cerus Endovascular today announced that it has received breakthrough device designation from the U.S. FDA for ...
8 February 2021 - The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device ...
8 February 2021 - Designation in patients with chronic myeloid leukaemia (CML) resistant or intolerant to prior treatments based on positive ...