16 November 2021 - Blackrock Neurotech today announces that the U.S. FDA has granted breakthrough device designation for its groundbreaking ...
24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. ...
23 November 2021 - Expediting development of GWave technology that may potentially improve the health and quality of life for millions ...
19 November 2021 - TriNetra is a circulating tumour cell detection blood test which is able to identify early stage ...
19 November 2021 - Theradaptive announced that the U.S. FDA has granted breakthrough medical device designation to its Osteo-Adapt SP Spinal ...
10 November 2021 - The U.S. FDA classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the ...
8 November 2021 - Man & Science announced today that it has been granted a breakthrough device designation by the Center ...
4 November 2021 - Soft exoskeleton device for stroke survivors will be for use at home and in the community ...
3 November 2021 - TecTraum today announced that the U.S. FDA has designated its flagship technology, pro2cool, as a breakthrough ...
2 November 2021 - Renew Bioscience announced it has received breakthrough device designation status from the U.S. FDA for the ...
26 October 2021 - Ortek announced today the widespread availability of its ECD device, which provides dental professionals a new diagnostic ...
20 October 2021 - Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita ...
19 October 2021 - The iQ Group Global, on behalf of its subsidiary, Life Science Biosensor Diagnostics, is pleased to announce ...
11 October 2021 - Quanterix Corporation announced today that its Simoa phospho-Tau 181 (pTau-181) blood test has been granted breakthrough ...
8 October 2021 - Alpha Tau Medical is pleased to announce that it has received breakthrough device designation for Alpha ...