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RSS FeedPosted by Michael Wonder on 07 Mar 2022
Merit Medical receives FDA breakthrough device designation for Embosphere microspheres for use in genicular artery embolisation for symptomatic knee osteoarthritis
7 March 2022 - Merit Medical Systems announced today that it has received breakthrough device designation from the U.S. FDA ...
Posted by Michael Wonder on 03 Mar 2022
AltPep receives FDA breakthrough device designation for SOBA-AD, a simple blood test for the detection of Alzheimer’s disease
1 March 2022 - AltPep Corporation today announced the U.S. FDA granted the company breakthrough device designation for its SOBA-AD diagnostic ...
Posted by Michael Wonder on 28 Feb 2022
Minimally invasive epilepsy treatment EASEE receives FDA breakthrough device designation
21 February 2022 - Precisis has received breakthrough device designation from the U.S. FDA for its EASEE brain stimulator. FDA’s ...
Posted by Michael Wonder on 25 Feb 2022
Noninvasix receives FDA breakthrough device designation for non-invasive monitoring technology for sepsis
23 February 2022 - LIVOx is first monitoring device to non-invasively monitor sepsis by detecting a key indicator of septic ...
Posted by Michael Wonder on 23 Feb 2022
FDA permits marketing of first condom specifically indicated for anal intercourse
23 February 2022 - Other FDA cleared condoms can continue to be used for contraception and to prevent sexually transmitted infections. ...
Posted by Michael Wonder on 23 Feb 2022
Medtronic receives FDA approval for InterStim X system, the next generation of the most personalised sacral nerve stimulation therapy for bladder and bowel control
22 December 2022 - New InterStim X system provides 10 to 15 years of battery life without the need to recharge. ...
Posted by Michael Wonder on 22 Feb 2022
NeuroSigma receives FDA breakthrough device designation for Monarch eTNS system
22 February 2022 - Monarch eTNS recognised as novel device for drug resistant epilepsy. ...
Posted by Michael Wonder on 16 Feb 2022
Bonalive Biomaterials granted FDA breakthrough device designation for a bone graft substitute that potentially protects against microbial colonisation
16 February 2022 - The Center for Devices and Radiological Health at the U.S. FDA has determined that Bonalive Orthopedics granules, ...
Posted by Michael Wonder on 16 Feb 2022
3D printing medical devices: stakeholders weigh in on FDA’s discussion paper
15 February 2022 - The US FDA has started thinking about how 3D printing of medical devices at the point ...
Posted by Michael Wonder on 16 Feb 2022
Foundation Medicine’s ctDNA monitoring assay, FoundationOne Tracker, granted breakthrough device designation by U.S. Food and Drug Administration
15 February 2022 - Foundation Medicine today announced that the U.S. FDA has granted a breakthrough device designation for its circulating ...
Posted by Michael Wonder on 16 Feb 2022
Cardiosense receives FDA breakthrough device designation for algorithm to identify patients at risk of decompensated heart failure
15 February 2022 - Cardiosense announced today that the U.S. FDA has granted the company breakthrough device status for its ...
Posted by Michael Wonder on 16 Feb 2022
Rapid Medical receives FDA breakthrough device designation for vasospasm treatment
15 February 2022 - Comaneci temporarily expands blood vessels, recognised as novel device for life-threatening disease. ...
Posted by Michael Wonder on 15 Feb 2022
Theradaptive wins additional FDA breakthrough designation for spinal fusion
15 February 2022 - Theradaptive announced that the U.S. FDA has granted breakthrough medical device designation for its OsteoAdapt SP Spinal ...
Posted by Michael Wonder on 04 Feb 2022
BioCardia receives FDA breakthrough device designation for CardiAMP cell therapy system for heart failure
3 February 2022 - BioCardia today announced that the U.S. FDA has granted breakthrough device designation for the CardiAMP Cell ...
Posted by Michael Wonder on 01 Feb 2022
Aussie device that gives eyes to the blind fast tracked in US
1 February 2022 - A world-first bionic eye that restores partial vision to the blind has been given “breakthrough” designation ...