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Op-Ed: FDA Needs to OK Rule Giving Seniors Access to FDA-Approved Medical Devices Under Medicare

Unlike drugs, which are typically covered by CMS immediately upon FDA approval, seniors can t access many FDA approved or cleared medical diagnostics and devices unless they can participate in a clinical study sanctioned by CMS. Those studies can take years requiring additional data and a lengthy regulatory process to determine coverage criteria and keep potentially lifesaving medical interventions from Medicare beneficiaries in the meantime. A new policy that was set to take effect in mid-March would have allowed seniors and their doctors decide whether or not they need those devices, but it was put on hold along with other pending regulations when the Biden administration took office. The proposed Medicare Coverage of Innovative Technology policy, which was delayed until May 15 pending regulatory review, leverages existing FDA legal authority through the Breakthrough Devices Program to identify a limited number of promising medical technologies and offers those products a shor

Op-Ed: Medicare Needs to OK Rule Giving Seniors Access to FDA-Approved Medical Devices

Unlike drugs, which are typically covered by CMS immediately upon FDA approval, seniors can t access many FDA approved or cleared medical diagnostics and devices unless they can participate in a clinical study sanctioned by CMS. Those studies can take years requiring additional data and a lengthy regulatory process to determine coverage criteria and keep potentially lifesaving medical interventions from Medicare beneficiaries in the meantime. A new policy that was set to take effect in mid-March would have allowed seniors and their doctors decide whether or not they need those devices, but it was put on hold along with other pending regulations when the Biden administration took office. The proposed Medicare Coverage of Innovative Technology policy, which was delayed until May 15 pending regulatory review, leverages existing FDA legal authority through the Breakthrough Devices Program to identify a limited number of promising medical technologies and offers those products a shor

CytoSorbents to Report Q1 2021 Operating and Financial Results

CytoSorbents to Report Q1 2021 Operating and Financial Results News provided by Share this article Share this article MONMOUTH JUNCTION, N.J., April 27, 2021 /PRNewswire/  CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, will report Q1 2021 financial results after the market close on Tuesday, May 4, 2021 at 4:45PM EST.  CytoSorbents management will host a live conference call and presentation webcast that will recount both operational and financial progress during Q1 2021 followed by a question and answer session. CytoSorbents Corporation to Report Q1 2021 Operating and Financial Results on Tuesday, May 4, 2021

CytoSorbents to Report Q1 2021 Operating and Financial Results

CytoSorbents to Report Q1 2021 Operating and Financial Results
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