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RSS FeedPosted by Michael Wonder on 17 Feb 2021
FDA approves first in the world, first-of-its-kind implant for the treatment of rare bone disease as a humanitarian use device
17 February 2021 - Today, the U.S. FDA approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. ...
Posted by Michael Wonder on 17 Feb 2021
Reflections on a record year for novel device innovation despite COVID-19 challenges
16 February 2021 - As we look ahead this year, it is important to pause and reflect on the important milestones ...
Posted by Michael Wonder on 15 Feb 2021
It’s time to fast track innovation in medical devices for children
11 February 2021 - When a baby arrived at Children’s National Hospital with a critically underdeveloped heart, it was clear ...
Posted by Michael Wonder on 11 Feb 2021
BrainCool receives FDA breakthrough device designation for Cooral System for prevention of oral mucositis
11 February 2021 - Recent Medicare reimbursement ruling provides an additional boost in paving the way for elimination of one of ...
Posted by Michael Wonder on 11 Feb 2021
BrainQ gets FDA breakthrough status for its device for reducing disability following stroke
11 February 2021 - The breakthrough device designation, which comes after new trial data, is expected to expedite the device's path ...
Posted by Michael Wonder on 11 Feb 2021
Cerus Endovascular receives FDA breakthrough device designation for its Contour Neurovascular System
11 February 2021 - Cerus Endovascular today announced that it has received breakthrough device designation from the U.S. FDA for ...
Posted by Michael Wonder on 09 Feb 2021
U.S. FDA grants breakthrough device designation to Vascular Perfusion Solutions for its visionary VP.S Encore cardiac transport device
8 February 2021 - The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device ...
Posted by Michael Wonder on 09 Feb 2021
ShiraTronics receives FDA breakthrough device designation for chronic migraine neurostimulation
8 February 2021 - ShiraTronics announced today that it has been granted a breakthrough device designation by the Center of Devices ...
Posted by Michael Wonder on 08 Feb 2021
FDA grants breakthrough device designation for Roche's Elecsys growth differentiation factor-15 assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients
8 February 2021 - FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to ...
Posted by Michael Wonder on 08 Feb 2021
Puzzle Medical Devices receives U.S. FDA breakthrough device designation for its revolutionary minimally invasive transcatheter heart pump
8 February 2021 - Puzzle Medical Devices announced today that the U.S. FDA has granted the company a breakthrough revice designation ...
Posted by Michael Wonder on 06 Feb 2021
FDA authorises marketing of novel device to reduce snoring and mild obstructive sleep apnea in patients 18 years and older
5 February 2021 - Today, the U.S. FDA authorised marketing of a new prescription only device intended to reduce snoring and ...
Posted by Michael Wonder on 03 Feb 2021
Geistlich Pharma granted FDA breakthrough device designation for Chondro-Gide articular cartilage cover
2 February 2021 - Geistlich Pharma announced that the Chondro-Gide articular cartilage cover has been granted a breakthrough device designation from ...
Posted by Michael Wonder on 27 Jan 2021
Alleviant Medical receives breakthrough device designation from FDA for transcatheter technology
25 January 2021 - Alleviant Medical today announced that the US FDA has granted the company a breakthrough device designation ...
Posted by Michael Wonder on 27 Jan 2021
PEDRA Technology receives FDA breakthrough device designation for its PEDRA Xauron real-time tissue perfusion system
25 January 2021 - Novel perfusion monitor achieves FDA breakthrough device Designation for real-time, peri-procedural monitoring of tissue perfusion in patients ...
Posted by Michael Wonder on 26 Jan 2021
FDA approves Theranica's Nerivio for acute treatment of migraine in adolescents
25 January 2021 - Theranica today announced that its Nerivio therapeutic device has received the FDA clearance to market for ...