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RSS FeedPosted 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 15 Feb 2022
MTAA welcomes patent box legislation
11 February 2022 - MTAA has welcomed the introduction of the Government’s Patent Box Bill into the House of Representatives ...
Posted by Michael Wonder on 15 Feb 2022
NICE recommends new diagnostic devices for men with suspected prostate cancer in draft guidance
15 February 2022 - Four new diagnostic devices for men with suspected prostate cancer, which reduce the chances of biopsy related ...
Posted by Michael Wonder on 14 Feb 2022
New CGM device for Australians with diabetes
14 February 2022 - Australians with diabetes will now have access to the next generation Dexcom G6 Continuous Glucose Monitoring, ...
Posted by Michael Wonder on 04 Feb 2022
To hell and back: devices meant to ease pain are causing trauma
5 February 2022 - A $35,000 treatment at the forefront of medical technology which pumps electric pulses into the spine ...
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 ...
Posted by Michael Wonder on 01 Feb 2022
Blue Note Therapeutics receives breakthrough device designation for prescription only digital therapeutic for acute myeloid leukaemia
31 January 2022 - Blue Note Therapeutics, a prescription digital therapeutics company dedicated to easing the burden of cancer and improving ...
Posted by Michael Wonder on 01 Feb 2022
Applaud Medical receives FDA breakthrough device designation for the company’s acoustic enhancer for use in conjunction with ureteroscopy with laser lithotripsy for the fragmentation of calcium based kidney stones
31 January 2022 - Applaud Medical today announced that its acoustic enhancer technology has received breakthrough device designation from the U.S. ...
Posted by Michael Wonder on 25 Jan 2022
Magnesium Development Company announces FDA breakthrough device designation for resorbable HC screw
24 January 2022 - Magnesium Development Company's fixation solution, the HC Screw, has received the FDA’s breakthrough device designation, having exceeded ...
Posted by Michael Wonder on 24 Jan 2022
Cook Medical receives FDA breakthrough designation for new drug eluting stent
21 January 2022 - Cook Medical has received breakthrough device designation from the US FDA on a new drug eluting stent ...