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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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