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RSS FeedPosted by Michael Wonder on 24 Jun 2021
Lilly's donanemab receives U.S. FDA's breakthrough therapy designation for treatment of Alzheimer's disease
24 June 2021 - The U.S. FDA granted breakthrough therapy designation for donanemab, Eli Lilly's investigational antibody therapy for Alzheimer's ...
Posted by Michael Wonder on 24 Jun 2021
Eisai and Biogen announce U.S. FDA grants breakthrough therapy designation for lecanemab (BAN2401), an anti-amyloid beta antibody for the treatment of Alzheimer's disease
24 June 2021 - Eisai and Biogen today announced that the U.S. FDA has granted breakthrough therapy designation for lecanemab (BAN2401), ...
Posted by Michael Wonder on 21 Jun 2021
Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire
21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...
Posted by Michael Wonder on 18 Jun 2021
The FDA grants a breakthrough device designation to the MIScoli, an innovative vertebral body tethering device to treat idiopathic scoliosis
18 June 2021 - Spinologics announced today that the U.S. FDA has granted the company a breakthrough device designation for its ...
Posted by Michael Wonder on 16 Jun 2021
VoluMetrix's NIVA|HF for heart failure patients designated as breakthrough device by U.S. FDA
15 June 2021 - NIVA|HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart ...
Posted by Michael Wonder on 16 Jun 2021
Novartis prostate cancer drug receives U.S. FDA breakthrough designation
17 June 2021 - Swiss drugmaker Novartis has received breakthrough therapy designation from the U.S. FDA for an experimental treatment ...
Posted by Michael Wonder on 09 Jun 2021
Ibex granted FDA breakthrough device designation
9 June 2021 - Ibex's Galen AI powered platform is recognised by the FDA as breakthrough technology with the potential to ...
Posted by Michael Wonder on 08 Jun 2021
Alpha Tau receives breakthrough device designation from the FDA for Alpha DaRT
8 June 2021 - Alpha Tau Medical is pleased to announce that it has received a breakthrough device designation for Alpha ...
Posted by Michael Wonder on 03 Jun 2021
Protagonist Therapeutics receives FDA breakthrough therapy designation for rusfertide in polycythemia vera
3 June 2021 - Designation further validates registrational path for rusfertide in polycythemia vera and facilitates potentially expedited development and review. ...
Posted by Michael Wonder on 01 Jun 2021
Janssen announces U.S. FDA breakthrough therapy designation granted for teclistamab for the treatment of relapsed or refractory multiple myeloma
1 June 2021 - U.S. milestone follows EMA PRIME designation for this BCMA bi-specific antibody for the treatment of relapsed or ...
Posted by Michael Wonder on 31 May 2021
BrainSee novel software is breakthrough for non-invasive detection and monitoring of Alzheimer’s disease at the early stage of mild cognitive impairment
28 May 2021 - Darmiyan’s AI solution reliably guides physicians on prognosis and clinical management of mild cognitive impairment patients. ...
Posted by Michael Wonder on 31 May 2021
FDA grants breakthrough device designation for smart orthopaedic implants
28 May 2021 - Intelligent Implants has announced today that its SmartFuse system has received breakthrough device designation by the ...
Posted by Michael Wonder on 27 May 2021
FDA grants Micro Interventional Devices breakthrough device designation for the MIA-T percutaneous tricuspid annuloplasty system
27 May 2021 - Micro Interventional Devices has received breakthrough device designation from the U.S. FDA for its MIA-T percutaneous ...
Posted by Michael Wonder on 26 May 2021
Woebot Health receives FDA breakthrough device designation for post partum depression treatment
26 May 2021 - WB001 is the first digital therapeutic designed to reduce the burden of post partum depression. ...
Posted by Michael Wonder on 26 May 2021
Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...