New Treatment From Shockwave Medical For Clogged Arteries Gets CMS Pass-Through Payment
Starting 1 July, Medicare beneficiaries with a certain type of cardiovascular disease will be able to receive an innovative treatment covered under their government plans.
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Shockwave Medical received a FDA premarket approval for its C2 coronary intravascular lithotripsy-based calcification remedy and announced its 2020 results, in line with expectations.
Fees for filing a premarket application with the US FDA increased 2.5% for fiscal year 2022, which is significantly less than the 7% they went up last year.
Research from the University of California, San Francisco claims that many deaths involving medical devices are incorrectly reported to the US agency, and says improving the accuracy of how these deaths are classified could improve patient safety.