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On May 14, 2021, CMS issued a new final rule that will further delay the effective date of the Medicare Coverage of Innovative Technology MCIT and Definition of Reasonable and Necessary Final Rule until no earlier than Dec. 15, 2021.
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...
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...
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 tha...
By Yakir Benzion, United With Israel The Israeli medical device company IceCure received a huge boost after American authorities approved the company’s revolutionary ProSense system for treating cancerous tumors by freezing them, Globes reported Sunday. The U.S. Food and Drug Administration (FDA) gave marketing approval to ProSense as part of the FDA’s Breakthrough Devices Program that fast-tracks new devices to the market. Based in Caesarea, north of Tel Aviv, and with offices in America, IceCure Medical developed a system that uses liquid nitrogen-based technology to freeze tumors so t...