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With Thursdays accelerated approval, Fabhalta is now indicated for patients with IgAN who are at risk of rapid disease progression, according to Novartis, defined as patients with a urine protein-to-creatinine ratio of at least 1.5 g/g

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While every care has been taken to ensure this information is always as accurate as possible, food products are regularly improved and nutrition content may occasionally change

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Per the applicant, the existing pass-through code C1747 (Endoscope, single-use ( i.e., disposable), urinary tract, imaging/illumination device (insertable)) does not appropriately describe the LithoVue TM Elite Ureteroscope because the category description does not include the LithoVue TM Elite Ureteroscope's pressure monitoring feature

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We note that we solicited comments on payment policies for software as a service in the CY 2026 OPPS/ASC proposed rule and refer readers to section III.F

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More Resources: TGA website Australian Regulatory Guidelines for Medical Devices (ARGMD) To access more information click on the Read More tab

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