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RSS FeedPosted by Michael Wonder on 29 Sep 2021
TransMedics receives FDA approval for its OCS Liver System for preservation and assessment of donor livers for transplantation
29 September 2021 - TransMedics today announced that the U.S. FDA has granted pre-market approval of its OCS Liver System ...
Posted by Michael Wonder on 29 Sep 2021
Nonagen Bioscience granted FDA breakthrough device designation
28 September 2021 - Nonagen Bioscience today announced Oncuria, their non-invasive bladder cancer test capable of predicting response to therapy, has ...
Posted by Michael Wonder on 29 Sep 2021
Selux Diagnostics earns FDA breakthrough device designation for next generation phenotyping platform for positive blood culture and sterile body fluid samples
28 September 2021 - Selux next generation phenotyping now qualifies for expedited FDA review process as single-platform technology for rapid antimicrobial ...
Posted by Michael Wonder on 20 Sep 2021
Abbott receives FDA approval for minimally invasive Portico with Flexnav TAVR system to treat patients with aortic valve disease
20 September 2021 - Transcatheter aortic valve replacement procedure treats people with symptomatic, severe aortic stenosis who are at high or ...
Posted by Michael Wonder on 20 Sep 2021
FDA clears first technology to distinguish between bacterial and viral infections using the body’s immune response – the MeMed BV test and MeMed key platform
20 September 2021 - MeMed BV is a first-of-its kind test that decodes the immune response to accurately distinguish between bacterial ...
Posted 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. ...