Blog
RSS FeedPosted by Michael Wonder on 20 Apr 2021
Amgen's investigational targeted treatment bemarituzumab granted breakthrough therapy designation
19 April 2021 - Designation is supported by results from the Phase 2 FIGHT trial. ...
Posted by Michael Wonder on 15 Apr 2021
Perimeter Medical Imaging AI receives U.S. FDA breakthrough device designation for its optical coherence tomography imaging system with ImgAssist AI
15 April 2021 - New designation provides potential pathway to expedite adoption of Perimeter's transformative medical imaging technology combined with artificial ...
Posted by Michael Wonder on 13 Apr 2021
vTv Therapeutics receives FDA breakthrough therapy designation for TTP399 for the treatment of type 1 diabetes
13 April 2021 - Designation offers potential for expedited development pathway and reinforces TTP399’s potential to provide a substantial clinical benefit. ...
Posted by Michael Wonder on 07 Apr 2021
IceCure Medical granted FDA breakthrough device designation for Prosense cryoablation system
5 April 2021 - IceCure Medical announced today that it has been granted designation as a breakthrough device from the ...
Posted by Michael Wonder on 01 Apr 2021
FDA grants breakthrough therapy designation for Taiho Oncology's futibatinib for treatment of advanced cholangiocarcinoma
1 April 2021 - Taiho Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for futibatinib (TAS-120), a ...
Posted by Michael Wonder on 31 Mar 2021
Premia Spine announces FDA breakthrough device designation for its TOPS spinal arthroplasty system
31 March 2021 - First-of-a-kind system designed to offer new treatment option for patients with spinal stenosis and spondylolisthesis. ...
Posted by Michael Wonder on 31 Mar 2021
Bluestar Genomics receives FDA breakthrough device designation for first-of-its-kind pancreatic cancer screening test
31 March 2021 - Company accelerates commercialisation efforts to address a million at-risk patients’ unmet needs. ...
Posted by Michael Wonder on 26 Mar 2021
FDA approves first in the world device to treat patients with congenital heart disease
26 March 2021 - New implant device provides less invasive option to treat pulmonary valve regurgitation for patients with a native ...
Posted by Michael Wonder on 24 Mar 2021
FDA grants two new breakthrough device designations for Natera’s Signatera MRD test
24 March 2021 - Natera today announced that the US FDA has granted two breakthrough device designations covering new intended ...
Posted by Michael Wonder on 24 Mar 2021
FDA grants breakthrough device designation to Tempus’ atrial fibrillation ECG analysis platform, developed in collaboration with Geisinger
24 March 2021 - Tempus today announced that the U.S. FDA has granted the company breakthrough device designation for its ECG ...
Posted by Michael Wonder on 18 Mar 2021
Stimdia Medical receives FDA breakthrough device designation for the pdSTIM system designed to facilitate weaning patients from mechanical ventilation
18 March 2021 - Stimdia Medical today announced the company’s pdSTIM system has received breakthrough device designation from the U.S. FDA. ...
Posted by Michael Wonder on 17 Mar 2021
Sparta Biomedical receives FDA breakthrough device designation for SBM-01 biomimetic implant
17 March 2021 - Sparta Biomedical today announced that its SBM-01 biomimetic implant has been granted a breakthrough device designation from ...
Posted by Michael Wonder on 15 Mar 2021
Update on finalisation of MCIT rule to provide national Medicare coverage for FDA breakthrough devices and diagnostics
15 March 2021 - Renalytix AI provides an update on the establishment of the Medicare Coverage of Innovative Technology (MCIT) ...
Posted by Michael Wonder on 15 Mar 2021
BioXcel Therapeutics receives FDA breakthrough therapy designation for BXCL501 for the acute treatment of agitation associated with dementia
15 March 2021 - Designation offers the potential for expedited development and review, highlighting the urgent need for new treatment options ...
Posted by Michael Wonder on 11 Mar 2021
Berlin Heals receives breakthrough device designation from FDA for its C-MIC heart failure device and initiates early feasibility study in the United States
11 March 2021 - Berlin Heals announced today that the US FDA has granted a breakthrough device designation for its ...