Blog
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 01 Sep 2021
MicroTransponder receives FDA approval for breakthrough device benefiting stroke survivors
31 August 2021 - MicroTransponder today announced US FDA premarket approval of the Vivistim Paired VNS System, which significantly improves the ...
Posted by Michael Wonder on 30 Aug 2021
Zimmer Biomet and Canary Medical announce FDA de novo classification grant and authorisation to market the world's first and only smart knee implant
30 August 2021 - Post-operative gait metrics to provide real world, objective patient data. ...
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 27 Aug 2021
FDA approves first of its kind stroke rehabilitation system
27 August 2021 - The U.S. FDA today approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation ...
Posted by Michael Wonder on 26 Aug 2021
Innovative Health Sciences receives FDA clearance for Insignis subcutaneous needle sets
26 August 2021 - Innovative Health Sciences announced today that it has received FDA clearance for its Insignis subcutaneous needle sets. ...
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 16 Aug 2021
Abbott's Amplatzer Amulet device approved by FDA to treat people with atrial fibrillation at risk of stroke
16 August 2021 - Amulet is the first and only minimally invasive treatment option to offer immediate closure of the left ...
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
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...
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 04 Aug 2021
Kestra Medical Technologies receives FDA premarket approval for ASSURE wearable cardioverter defibrillator
3 August 2021 - Kestra Medical Technologies announced today that the company has received U.S. FDA premarket approval for the ASSURE ...