Blog
RSS FeedPosted by Michael Wonder on 15 Sep 2021
Final report on the Australian Government response to the recommendations of the Senate Community Affairs References Committee Report
15 September 2021 - The Government acknowledges the efforts and actions detailed in this progress report to implement the Senate ...
Posted by Michael Wonder on 14 Sep 2021
Nyxoah announces U.S. FDA breakthrough device designation granted for the Genio system for obstructive sleep apnea and complete concentric collapse
14 September 2021 - Nyxoah today announced that the U.S. FDA has granted the Genio bilateral hypoglossal nerve stimulation system breakthrough ...
Posted by Michael Wonder on 10 Sep 2021
FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer
9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...
Posted by Michael Wonder on 08 Sep 2021
Intelivation Technologies received FDA approval for the Advantage-C PEEK cervical interbody fusion device
8 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Advantage-C PEEK cervical ...
Posted by Michael Wonder on 08 Sep 2021
FDA grants Madorra breakthrough device designation status for treatment of moderate to severe vulvovaginal atrophy
8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...
Posted by Michael Wonder on 01 Sep 2021
In2Bones receives FDA clearance for pre-surgery OrthoPlanify patient specific planning software and 3D printed cutting guides for Quantum Total Ankle System
1 September 2021 - In2Bones Global today announces the FDA clearance of OrthoPlanify patient-specific planning software and 3D printed cutting ...
Posted by Michael Wonder on 01 Sep 2021
Intelivation Technologies received FDA approval for the Golden Isles Pedicle Screw System
1 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Golden Isles Pedicle ...
Posted 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 ...