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RSS FeedPosted by Michael Wonder on 09 Feb 2023
CoolHealth enters US market with TargetCool, a breakthrough FDA class II medical device offering unprecedented precise, rapid cooling for pain management and bruise minimisation
8 February 2023 - CoolHealth is entering the US market with a breakthrough FDA Class II medical device, TargetCool. ...
Posted by Michael Wonder on 23 Jan 2023
RenalGuard Therapy receives FDA breakthrough device designation for prevention of cardiac surgery associated AKI
20 January 2023 - CardioRenal Systems announced today that the FDA granted breakthrough device designation for its RenalGuard Therapy device ...
Posted by Michael Wonder on 19 Jan 2023
Abbott receives FDA approval for Navitor, a next generation TAVI system designed to treat aortic stenosis
17 January 2023 - Abbott's new Navitor device features advancements to improve patient care, including reducing or eliminating risk of blood ...
Posted by Michael Wonder on 12 Jan 2023
Medcura receives breakthrough device designation for its LifeGel absorbable surgical hemostat
13 January 2023 - Medcura announces that the US FDA has granted the coveted breakthrough device designation for its LifeGel absorbable ...
Posted by Michael Wonder on 11 Jan 2023
Micronoma receives FDA breakthrough device designation for OncobiotaLUNG, a novel liquid biopsy assay for lung carcinoma detection
10 January 2023 - The OncobiotaLUNG assay is the first blood microbiome driven liquid biopsy with proven effectiveness, including identifying cancer ...
Posted by Michael Wonder on 11 Jan 2023
EndoTheia announces FDA breakthrough device designation for technology to improve endoscopic surgery
10 January 2023 - EndoTheia announced today that it has gained priority status from the FDA by receiving a breakthrough ...
Posted by Michael Wonder on 10 Jan 2023
Four types of bias in medical AI are running under the FDA’s radar
9 January 2023 - Although artificial intelligence is entering health care with great promise, clinical artificial intelligence tools are prone ...
Posted by Michael Wonder on 09 Jan 2023
Opticyte earns FDA breakthrough device designation for the first cell O2 patient monitor for organ failure
9 January 2023 - Opticyte leverages proprietary machine learning to non-invasively assess organ dysfunction due to low cellular oxygenation in ...
Posted by Michael Wonder on 04 Jan 2023
Burning Rock received FDA breakthrough device designation for its OverC multi-cancer detection blood test
3 January 2023 - Burning Rock today announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted breakthrough device ...
Posted by Michael Wonder on 03 Jan 2023
US FDA grants breakthrough designation for blood test to help diagnose inaccessible brain tumours
2 January 2023 - Datar Cancer Genetics now has three breakthrough designations granted by the US FDA, including liquid biopsies ...
Posted by Michael Wonder on 30 Dec 2022
The FDA’s ‘breakthrough’ program for medical devices keeps gaining steam
28 December 2022 - For medical devices in the Breakthrough Devices Program, 2022 has been a breakout year. ...
Posted by Michael Wonder on 28 Dec 2022
EOFlow submits application to the US FDA for its wearable insulin pump 'EOPatch'
27 December 2022 - Plans to finalise its US distribution strategy in 2023. ...
Posted by Michael Wonder on 04 Nov 2022
AVITA Medical announces FDA breakthrough device designations for the Recell system
3 November 2022 - AVITA Medical announced today that the FDA granted the Recell system designations as a breakthrough device for ...
Posted by Michael Wonder on 20 Oct 2022
Sinaptica Therapeutics announces FDA breakthrough device designation for its novel non-invasive neurostimulation treatment for Alzheimer’s disease
19 October 2022 - Breakthrough designation is based on positive outcomes from a Phase 2 clinical trial in mild to ...
Posted by Michael Wonder on 18 Oct 2022
Axoft brain implant technology is granted FDA breakthrough device designation
18 October 2022 - Axoft today launched and announced FDA breakthrough device designation for its brain-machine interface to better treat ...