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RSS FeedPosted by Michael Wonder on 20 Jan 2022
Pathogenomix granted FDA breakthrough device designation
19 January 2022 - Patho-Seq uses next generation sequencing to rapidly identify bacteria from human samples during dangerous and life-threatening ...
Posted by Michael Wonder on 19 Jan 2022
Sensydia receives FDA breakthrough device designation for CPS non-invasive cardiac monitoring device
19 January 2022 - Sensydia today announced that its cardiac performance system has been granted breakthrough device designation by the United ...
Posted by Michael Wonder on 19 Jan 2022
FDA grants breakthrough device designation to Diadem's AlzoSure predict prognostic blood test for the early prediction of Alzheimer's disease
18 January 2022 - First prognostic blood test that can predict likely progression to Alzheimer's disease up to six years in ...
Posted by Michael Wonder on 19 Jan 2022
NeuroMetrix receives FDA breakthrough device designation for treatment of chronic chemotherapy induced peripheral neuropathy with its wearable neurostimulation technology
18 January 2022 - NeuroMetrix today announced that its Quell technology has received breakthrough designation from the U.S. FDA for reducing ...
Posted by Michael Wonder on 19 Dec 2021
Fist Assist Devices receives FDA “breakthrough device” designation for the world’s first wearable vein dilation device for ESRD patients
16 December 2021 - Indication for pre-surgical vein dilation use to promote AV fistula creation. ...
Posted by Michael Wonder on 14 Dec 2021
Health technology assessment: European Commission welcomes the adoption of new rules to improve access to innovative technologies
13 December 2021 - Today, the Regulation on Health Technology Assessment, a deliverable of the EU Pharmaceutical Strategy, has been adopted. ...
Posted by Michael Wonder on 14 Dec 2021
EU regulation passed: G-BA works on European HTA assessment
14 December 2021 - Today the EU Parliament passed the EU-HTA regulation for a joint health technology assessment, which includes, ...
Posted by Michael Wonder on 14 Dec 2021
FDA publishes discussion paper and seeks public input on 3D printing of medical devices at the point of care
10 December 2021 - Today, the U.S. FDA published a discussion paper regarding 3D printing medical devices at the point of ...
Posted by Michael Wonder on 13 Dec 2021
InterVene’s BlueLeaf Endovenous Valve Formation System granted breakthrough device designation by the FDA
13 December 2021 - InterVene announced today that it has received breakthrough device designation by the FDA for the company’s BlueLeaf ...
Posted by Michael Wonder on 07 Dec 2021
Linus Biotechnology receives FDA breakthrough device designation for StrandDx-ASD exposome sequencing diagnostic
7 December 2021 - Linus Biotechnology today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health ...
Posted by Michael Wonder on 06 Dec 2021
HCF calls for independent regulator of medical devices
6 December 2021 - Health insurer HCF has raised concerns that some doctors may be deciding what device to implant ...
Posted by Michael Wonder on 05 Dec 2021
RefleXion receives breakthrough device designation for lung cancer treatment
1 December 2021 - RefleXion Medical today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 04 Dec 2021
Reforms needed for FDA’s regulation of medical devices
3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex ...
Posted by Michael Wonder on 03 Dec 2021
ZetaMet receives breakthrough device designation from U.S. FDA for treatment of metastatic bone cancers
1 December 2021 - The technology is a first of its kind molecular pathway designed to suspend cancer, inhibit pain, and ...
Posted by Michael Wonder on 01 Dec 2021
Silverlon receives FDA breakthrough device designation for radiation dermatitis and cutaneous radiation injury
30 November 2021 - Innovative Silverlon silver plated nylon dressing contains more metallic silver than any other dressing; anti-microbial properties of ...