Page 13 - Breakthrough Devices Program News Today

/PRNewswire/ -- Selux Diagnostics, Inc., which is leading a new era in personalized diagnostics to combat superbug infections and fight antibiotic resistance,...

The MCIT/RN Rule was intended to address concerns that delay or uncertainty around Medicare coverage hampered beneficiary access to innovative technologies.

On September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) published a proposed rule, which (if finalized) would repeal the Agency’s Medicare Coverage...

Centers for Medicare & Medicaid Services CMS proposed rule would repeal Medicare Coverage of Innovative Technology & Definition of Reasonable and Necessary MCIT/R&N final rule; pathway to provide national Medicare coverage of medical devices designated Breakthrough Devices by Food and Drug Administration FDA

Helius Medical Technologies Inc has received Breakthrough Designation from the US Food and Drug Administration for its PoNS device as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, it announces.

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 cant 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 m...

Unlike drugs, which are typically covered by CMS immediately upon FDA approval, seniors cant 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 m...

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...

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,...