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RSS FeedPosted 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 30 Nov 2022
Swiss National Council votes to accept FDA approved medical devices
29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...
Posted by Michael Wonder on 18 Nov 2022
Diabetic accuses PHARMAC of faulty analysis of glucose monitors
17 November 2022 - Insulin-dependent diabetics say PHARMAC's decision to delay funding a potentially life-saving device appears to be based ...
Posted by Michael Wonder on 15 Nov 2022
Government supporting Australians living with type 1 diabetes
13 November 2022 - The Albanese Government is changing the lives for the 130,000 Australians living with type 1 diabetes by ...
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 02 Nov 2022
New reimbursement approved by the Japanese Ministry of Health, Labor and Welfare for the Accuray CyberKnife system to treat trigeminal neuralgia, a condition often causing severe facial pain
26 October 2022 - Accuray Incorporated announced today that the Japanese MHLW has approved reimbursement for the CyberKnife system for the ...
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 ...