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Changing Course, CMS Proposes to Repeal Medicare Coverage Pathway for FDA-Designated "Breakthrough Devices" | Nelson Mullins Riley & Scarborough LLP

On September 15, 2021, the Centers for Medicare & Medicaid Services (โ€œCMSโ€ or the โ€œAgencyโ€) published a proposed rule, which (if finalized) would repeal the Agencyโ€™s Medicare Coverage...
Leea Fleisher Nelson Mullins Lee Fleisher Breakthrough Devices Program Centers For Medicare Medicaid Services Agency Medicare Coverage Of Innovative Technology

CMS Medicare Coverage Pathway for FDA-Designated Breakthrough Devices Repeal Proposed

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
Leea Fleisher Lee Fleisher Breakthrough Devices Program Centers For Medicare Medicaid Services Drug Administration Medicare Coverage Of Innovative Technology

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BrainQ raises $40M to transform stroke patient rehabilitation with its home therapy device – TechCrunch

If you injure your elbow, surgery can help. If you lose a leg, prostheses are available. But problems within the brain are more difficult to treat, and for stroke victims, rehabilitation is largely left to the body’s own repair mechanisms. BrainQ aims to change that with a device that stimulates the damaged part of the […]
Yotam Drechsler Dexcel Pharma Breakthrough Device Image Credits Hanaco Ventures Peregrine Ventures

MedRhythms Closes $25M Series B Funding to Advance Digital Therapeutics Platform

MedRhythms Closes $25M Series B Funding to Advance Digital Therapeutics Platform MedRhythms announces the closing of a $25 million Series B financing round co-led by Morningside Ventures and Advantage Capital, with participation from existing investor Werth Family Investment Associates. It has raised a total of $34 million in gross proceeds from private financings since inception. The proceeds from the Series B financing will enable MedRhythms to expand its team and key corporate functions as t...
United States Brian Harris Chris Harris Stephen Bruso Werth Family Investment Associates Drug Administration

Community Scoop » Intestinal Infusion System Wins NZ Medtech Innovation Award

Press Release โ€“ Medical Technology Association of New Zealand The Insides System, a Kiwi-developed therapeutic intestinal contents (chyme) reinfusion system for intestinal failure (a severe condition where the body is unable to maintain adequate nutrition via the intestines) has won the James & Wells โ€ฆ The Insidesโ„ข System, a Kiwi-developed therapeutic intestinal contents (chyme) reinfusion system for intestinal failure (a severe condition where the body is unable to maintain adequate nut...
New Zealand Zealand Dhbs Faye Sumner Martyn Harvey James Wells Giles Chanwai

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