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RSS FeedPosted by Michael Wonder on 01 Sep 2021
U.S. FDA grants breakthrough device designation for innovative EndoSound vision ultrasound system
1 September 2021 - Endosound announced today that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. FDA. ...
Posted by Michael Wonder on 30 Aug 2021
FDA grants breakthrough device designation for ImpediMed's SOZO digital health platform for renal failure
30 August 2021 - FDA recognises potential of SOZO digital health platform to assist clinicians in measuring exact fluid volume of ...
Posted by Michael Wonder on 26 Aug 2021
CellMax Life earns FDA breakthrough device designation for colon cancer & pre-cancerous adenomas screening blood test
25 August 2021 - FirstSight now qualifies for expedited FDA review process as a blood test for detection of advanced neoplasia ...
Posted by Michael Wonder on 24 Aug 2021
FDA grants breakthrough device designation for renal failure
23 August 2021 - ImpediMed is pleased to announce SOZO has received FDA breakthrough device designation for a proposed indication ...
Posted by Michael Wonder on 18 Aug 2021
FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
18 August 2021 - The United States FDA has granted breakthrough device designation to Abiomed’s Impella ECP expandable percutaneous heart ...
Posted by Michael Wonder on 17 Aug 2021
Helius Medical Technologies announces FDA breakthrough device designation for the treatment of dynamic gait and balance deficits following a stroke
17 August 2021 - Helius Medical Technologies today announced that it has received breakthrough designation from the U.S. FDA for its ...
Posted by Michael Wonder on 12 Aug 2021
Second U.S. FDA breakthrough device designation granted to CytoSorbents' DrugSorb-ATR anti-thrombotic removal system adding the removal of market leading direct oral anti-coagulants during urgent cardiothoracic surgery
12 August 2021 - FDA breakthrough designation granted to CytoSorbents' DrugSorb-ATR for removal of apixaban and rivaroxaban to reduce the risk ...
Posted by Michael Wonder on 12 Aug 2021
Junshi Biosciences and Coherus announce U.S. FDA breakthrough therapy designation granted for toripalimab for first-line treatment of nasopharyngeal carcinoma
12 August 2021 - First-line nasopharyngeal indication and second/third line indications to be concurrently submitted 3Q 2021 in the toripalimab ...
Posted by Michael Wonder on 11 Aug 2021
Swing Therapeutics receives FDA breakthrough device designation for digital therapeutic for the management of fibromyalgia, launches real world study
11 August 2021 - Approach based on acceptance and commitment therapy and a foundational clinically validated digital program licensed from University ...
Posted by Michael Wonder on 06 Aug 2021
Altoida awarded FDA breakthrough designation for development of world’s first precision neurology device for prediction of Alzheimer's disease
5 August 2021 - Breakthrough designation will advance the development of industry’s first predictive diagnostic device for conversion to Alzheimer’s disease, ...
Posted by Michael Wonder on 05 Aug 2021
Eiger announces FDA breakthrough therapy designation for avexitide for treatment of congenital hyperinsulinism
5 August 2021 - All five orphan programs now have breakthrough therapy designation. ...
Posted by Michael Wonder on 04 Aug 2021
Cerus Corporation announces CMS has granted new technology add-on payment for INTERCEPT fibrinogen complex
3 August 2021 - New technology add-on payment provides incremental reimbursement under CMS’ Inpatient Prospective Payment System for INTERCEPT Fibrinogen Complex. ...
Posted by Michael Wonder on 04 Aug 2021
FDA grants breakthrough device designation status for Hancock Jaffe's VenoValve
3 August 2021 - VenoValve is a potential treatment for approximately 2.4 million U.S. patients that suffer from severe chronic venous ...
Posted by Michael Wonder on 29 Jul 2021
Biofourmis earns FDA's first ever breakthrough device designation for a novel digital therapeutic for heart failure
29 July 2021 - BiovitalsHF approved for expedited FDA review process as a first-in-class digital therapeutic for heart failure that augments ...
Posted by Michael Wonder on 29 Jul 2021
Arrowhead Pharmaceuticals receives breakthrough therapy designation from U.S. FDA for ARO-AAT for the treatment of alfa-1 anti-trypsin deficiency associated liver disease
29 July 2021 - Full enrollment reached in Phase 2 SEQUOIA study of ARO-AAT. ...